Pub Date : 2025-01-01DOI: 10.1001/jamapsychiatry.2024.2752
M Ishrat Husain, Tayyeba Kiran, Rabia Sattar, Ameer B Khoso, Ming Wai Wan, Daisy R Singla, Madeha Umer, Rabdino Mangrio, Paul Bassett, Imran B Chaudhry, Shehla N Zafar, Farhat A Jafri, Nasim Chaudhry, Nusrat Husain
<p><strong>Importance: </strong>Male postpartum depression is prevalent across populations; however, there is limited evidence on strategies to address it, particularly in low-income settings.</p><p><strong>Objective: </strong>To evaluate the effectiveness of Learning Through Play Plus Dads (LTP + Dads), a nonspecialist-delivered psychosocial intervention, in improving symptoms of male postpartum depression compared to treatment as usual.</p><p><strong>Design, setting, and participants: </strong>This cluster randomized clinical trial was conducted in Karachi, Pakistan, between June 2018 and November 2019. Assessors were blind to treatment allocation. Participants were recruited from 2 large towns in the city of Karachi via basic health units. Fathers aged 18 years and older with a DSM-5 diagnosis of major depressive episode and a child younger than 30 months were recruited. Of 1582 fathers approached, 1527 were screened and 357 were randomized in a 1:1 ratio to either the intervention or treatment as usual; 328 were included in the final analysis. Data were analyzed from April to June 2022.</p><p><strong>Interventions: </strong>LTP + Dads is a manualized intervention combining parenting skills training, play therapy, and cognitive behavior therapy. The intervention was delivered by community health workers via 12 group sessions over 4 months.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was change in 17-item Hamilton Depression Rating Scale score at 4 months. Secondary outcomes included anxiety symptoms; parenting stress; intimate partner violence; functioning; quality of life; and child social, emotional, and physical health outcomes. Assessments were completed at baseline and 4 and 6 months postrandomization.</p><p><strong>Results: </strong>Of the 357 fathers included (mean [SD] age, 31.44 [7.24] years), 171 were randomized to the intervention and 186 to treatment as usual. Participants randomized to the intervention demonstrated significantly greater improvements in depression (group difference ratio [GDR], 0.66; 95% CI, 0.47 to 0.91; P < .001), anxiety (GDR, 0.62; 95% CI, 0.48 to 0.81; P < .001), parenting stress (GDR, -12.5; 95% CI, -19.1 to -6.0; P < .001), intimate partner violence (GDR, 0.89; 95% CI, 0.80 to 1.00; P = .05), disability (GDR, 0.77; 95% CI, 0.61 to 0.97; P = .03), and health-related quality of life (GDR, 12.7; 95% CI, 0.17 to 0.34; P < .001) at 4 months. The difference in depression and parenting stress was sustained at 6 months. Children of fathers randomized to the parenting intervention had significantly greater improvements in social-emotional development scores (mean difference, -20.8; 95% CI, -28.8 to -12.9; P < .001) at 6 months.</p><p><strong>Conclusions and relevance: </strong>The psychosocial parenting intervention in this study has the potential to improve paternal mental health and child development in Pakistan. Further studies in other populations and with longer follow-up are warranted
{"title":"A Group Parenting Intervention for Male Postpartum Depression: A Cluster Randomized Clinical Trial.","authors":"M Ishrat Husain, Tayyeba Kiran, Rabia Sattar, Ameer B Khoso, Ming Wai Wan, Daisy R Singla, Madeha Umer, Rabdino Mangrio, Paul Bassett, Imran B Chaudhry, Shehla N Zafar, Farhat A Jafri, Nasim Chaudhry, Nusrat Husain","doi":"10.1001/jamapsychiatry.2024.2752","DOIUrl":"10.1001/jamapsychiatry.2024.2752","url":null,"abstract":"<p><strong>Importance: </strong>Male postpartum depression is prevalent across populations; however, there is limited evidence on strategies to address it, particularly in low-income settings.</p><p><strong>Objective: </strong>To evaluate the effectiveness of Learning Through Play Plus Dads (LTP + Dads), a nonspecialist-delivered psychosocial intervention, in improving symptoms of male postpartum depression compared to treatment as usual.</p><p><strong>Design, setting, and participants: </strong>This cluster randomized clinical trial was conducted in Karachi, Pakistan, between June 2018 and November 2019. Assessors were blind to treatment allocation. Participants were recruited from 2 large towns in the city of Karachi via basic health units. Fathers aged 18 years and older with a DSM-5 diagnosis of major depressive episode and a child younger than 30 months were recruited. Of 1582 fathers approached, 1527 were screened and 357 were randomized in a 1:1 ratio to either the intervention or treatment as usual; 328 were included in the final analysis. Data were analyzed from April to June 2022.</p><p><strong>Interventions: </strong>LTP + Dads is a manualized intervention combining parenting skills training, play therapy, and cognitive behavior therapy. The intervention was delivered by community health workers via 12 group sessions over 4 months.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was change in 17-item Hamilton Depression Rating Scale score at 4 months. Secondary outcomes included anxiety symptoms; parenting stress; intimate partner violence; functioning; quality of life; and child social, emotional, and physical health outcomes. Assessments were completed at baseline and 4 and 6 months postrandomization.</p><p><strong>Results: </strong>Of the 357 fathers included (mean [SD] age, 31.44 [7.24] years), 171 were randomized to the intervention and 186 to treatment as usual. Participants randomized to the intervention demonstrated significantly greater improvements in depression (group difference ratio [GDR], 0.66; 95% CI, 0.47 to 0.91; P < .001), anxiety (GDR, 0.62; 95% CI, 0.48 to 0.81; P < .001), parenting stress (GDR, -12.5; 95% CI, -19.1 to -6.0; P < .001), intimate partner violence (GDR, 0.89; 95% CI, 0.80 to 1.00; P = .05), disability (GDR, 0.77; 95% CI, 0.61 to 0.97; P = .03), and health-related quality of life (GDR, 12.7; 95% CI, 0.17 to 0.34; P < .001) at 4 months. The difference in depression and parenting stress was sustained at 6 months. Children of fathers randomized to the parenting intervention had significantly greater improvements in social-emotional development scores (mean difference, -20.8; 95% CI, -28.8 to -12.9; P < .001) at 6 months.</p><p><strong>Conclusions and relevance: </strong>The psychosocial parenting intervention in this study has the potential to improve paternal mental health and child development in Pakistan. Further studies in other populations and with longer follow-up are warranted","PeriodicalId":14800,"journal":{"name":"JAMA Psychiatry","volume":" ","pages":"22-30"},"PeriodicalIF":22.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11447622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1001/jamapsychiatry.2024.2871
Artur Menegaz de Almeida, Francisco Cezar Aquino de Moraes, Maria Eduarda Cavalcanti Souza, Jorge Henrique Cavalcanti Orestes Cardoso, Fernanda Tamashiro, Celso Miranda, Lilianne Fernandes, Michele Kreuz, Francinny Alves Kelly
Importance: Seasonal humor disorders are prone to have a link with daylight exposure. However, the effect of external light on nonseasonal disorders remains unclear. Evidence is lacking for the validity of bright light therapy (BLT) as an adjunctive treatment for these patients.
Objective: To assess BLT effectiveness as an adjunctive treatment for nonseasonal depressive disorders.
Data sources: In March 2024, a comprehensive search was performed of publications in the MEDLINE, Embase, and Cochrane databases for randomized clinical trials (RCTs) evaluating BLT effects in patients with nonseasonal depression.
Study selection: RCTs published since 2000 were eligible. Comparisons between BLT and dim red light or antidepressant monotherapy alone were considered for inclusion.
Data extraction and synthesis: Using the systematic review approach on RCTs published from January 1, 2000, through March 25, 2024, differences between patients treated with and without BLT were estimated using the Mantel-Haenszel method; heterogeneity was assessed using I2 statistics.
Main outcomes and measures: Remission of symptoms, response to treatment rates, and depression scales were assessed.
Results: In this systematic review and meta-analysis of 11 unique trials with data from 858 patients (649 female [75.6%]), statistically significant better remission and response rates were found in the BLT group (remission: 40.7% vs 23.5%; odds ratio [OR], 2.42; 95% CI, 1.50-3.91; P <.001; I2 = 21%; response: 60.4% vs 38.6%; OR, 2.34; 95% CI, 1.46-3.75; P <.001; I2 = 41%). With BLT, subgroup analysis based on follow-up times also showed better remission (<4 weeks: 27.4% vs 9.2%; OR, 3.59; 95% CI, 1.45-8.88; P = .005; I2 = 0% and >4 weeks: 46.6% vs 29.1%; OR, 2.18; 95% CI, 1.19-4.00; P = .01; I2 = 47%) and response (<4 weeks: 55.6% vs 27.4%; OR, 3.65; 95% CI, 1.81-7.33; P <.001; I2 = 35% and >4 weeks: 63.0% vs 44.9%; OR, 1.79; 95% CI, 1.01-3.17; P = .04; I2 = 32%) rates.
Conclusions and relevance: Results of this systematic review and meta-analysis reveal that BLT was an effective adjunctive treatment for nonseasonal depressive disorders. Additionally, results suggest that BLT may improve the response time to the initial treatment.
{"title":"Bright Light Therapy for Nonseasonal Depressive Disorders: A Systematic Review and Meta-Analysis.","authors":"Artur Menegaz de Almeida, Francisco Cezar Aquino de Moraes, Maria Eduarda Cavalcanti Souza, Jorge Henrique Cavalcanti Orestes Cardoso, Fernanda Tamashiro, Celso Miranda, Lilianne Fernandes, Michele Kreuz, Francinny Alves Kelly","doi":"10.1001/jamapsychiatry.2024.2871","DOIUrl":"10.1001/jamapsychiatry.2024.2871","url":null,"abstract":"<p><strong>Importance: </strong>Seasonal humor disorders are prone to have a link with daylight exposure. However, the effect of external light on nonseasonal disorders remains unclear. Evidence is lacking for the validity of bright light therapy (BLT) as an adjunctive treatment for these patients.</p><p><strong>Objective: </strong>To assess BLT effectiveness as an adjunctive treatment for nonseasonal depressive disorders.</p><p><strong>Data sources: </strong>In March 2024, a comprehensive search was performed of publications in the MEDLINE, Embase, and Cochrane databases for randomized clinical trials (RCTs) evaluating BLT effects in patients with nonseasonal depression.</p><p><strong>Study selection: </strong>RCTs published since 2000 were eligible. Comparisons between BLT and dim red light or antidepressant monotherapy alone were considered for inclusion.</p><p><strong>Data extraction and synthesis: </strong>Using the systematic review approach on RCTs published from January 1, 2000, through March 25, 2024, differences between patients treated with and without BLT were estimated using the Mantel-Haenszel method; heterogeneity was assessed using I2 statistics.</p><p><strong>Main outcomes and measures: </strong>Remission of symptoms, response to treatment rates, and depression scales were assessed.</p><p><strong>Results: </strong>In this systematic review and meta-analysis of 11 unique trials with data from 858 patients (649 female [75.6%]), statistically significant better remission and response rates were found in the BLT group (remission: 40.7% vs 23.5%; odds ratio [OR], 2.42; 95% CI, 1.50-3.91; P <.001; I2 = 21%; response: 60.4% vs 38.6%; OR, 2.34; 95% CI, 1.46-3.75; P <.001; I2 = 41%). With BLT, subgroup analysis based on follow-up times also showed better remission (<4 weeks: 27.4% vs 9.2%; OR, 3.59; 95% CI, 1.45-8.88; P = .005; I2 = 0% and >4 weeks: 46.6% vs 29.1%; OR, 2.18; 95% CI, 1.19-4.00; P = .01; I2 = 47%) and response (<4 weeks: 55.6% vs 27.4%; OR, 3.65; 95% CI, 1.81-7.33; P <.001; I2 = 35% and >4 weeks: 63.0% vs 44.9%; OR, 1.79; 95% CI, 1.01-3.17; P = .04; I2 = 32%) rates.</p><p><strong>Conclusions and relevance: </strong>Results of this systematic review and meta-analysis reveal that BLT was an effective adjunctive treatment for nonseasonal depressive disorders. Additionally, results suggest that BLT may improve the response time to the initial treatment.</p>","PeriodicalId":14800,"journal":{"name":"JAMA Psychiatry","volume":" ","pages":"38-46"},"PeriodicalIF":22.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11447633/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1001/jamapsychiatry.2024.3543
Sarah Herzog, Elizabeth A Bartlett, Francesca Zanderigo, Hanga C Galfalvy, Ainsley Burke, Akiva Mintz, Mike Schmidt, Eric Hauser, Yung-Yu Huang, Nadine Melhem, M Elizabeth Sublette, Jeffrey M Miller, J John Mann
<p><strong>Importance: </strong>Brain translocator protein 18k Da (TSPO) binding, a putative marker of neuroinflammatory processes (eg, gliosis), is associated with stress and elevated in depressed and suicidal populations. However, it is unclear whether neuroinflammation moderates the impact of daily life stress on suicidal ideation and negative affect, thereby increasing risk for suicidal behavior.</p><p><strong>Objective: </strong>To examine the association of TSPO binding in participants with depression with real-world daily experiences of acute stress-related suicidal ideation and negative affect, as well as history of suicidal behavior and clinician-rated suicidal ideation.</p><p><strong>Design, setting, and participants: </strong>Data for this cross-sectional study were collected from June 2019 through July 2023. Procedures were conducted at a hospital-based research center in New York, New York. Participants were recruited via clinical referrals, the Columbia University research subject web portal, and from responses to internet advertisements. Of 148 participants who signed informed consent for study protocols, 53 adults aged 18 to 60 years who met DSM-5 diagnostic criteria for current major depressive disorder completed procedures with approved data and were enrolled. Participants were free of schizophrenia spectrum disorders, active physical illness, cognitive impairment, and substance intoxication or withdrawal at the time of scan.</p><p><strong>Exposures: </strong>All participants underwent positron emission tomography imaging of TSPO binding with 11C-ER176 and concurrent arterial blood sampling.</p><p><strong>Main outcome and measures: </strong>A weighted average of 11C-ER176 total distribution volume (VT) was computed across 11 a priori brain regions and made up the primary outcome measure. Clinician-rated suicidal ideation was measured via the Beck Scale for Suicidal Ideation (BSS). A subset of participants (n = 21) completed 7 days of ecological momentary assessment (EMA), reporting daily on suicidal ideation, negative affect, and stressors.</p><p><strong>Results: </strong>In the overall sample of 53 participants (mean [SD] age, 29.5 [9.8] years; 37 [69.8%] female and 16 [30.2%] male), 11C-ER176 VT was associated at trend levels with clinician-rated suicidal ideation severity (β, 0.19; 95% CI, -0.03 to 0.39; P = .09) and did not differ by suicide attempt history (n = 15; β, 0.18; 95% CI, -0.04 to 0.37; P = .11). Exploratory analyses indicated that presence of suicidal ideation (on BSS or EMA) was associated with higher 11C-ER176 VT (β, 0.21; 95% CI, 0.01 to 0.98; P = .045). In 21 participants who completed EMA, 11C-ER176 VT was associated with greater suicidal ideation and negative affect during EMA periods with stressors compared with nonstress periods (β, 0.12; SE, 0.06; 95% CI, 0.01 to 0.23; P = .03 and β, 0.19; SE, 0.06; 95% CI, 0.08 to 0.30; P < .001, respectively).</p><p><strong>Conclusion and relevance: </strong>TSPO bindi
{"title":"Neuroinflammation, Stress-Related Suicidal Ideation, and Negative Mood in Depression.","authors":"Sarah Herzog, Elizabeth A Bartlett, Francesca Zanderigo, Hanga C Galfalvy, Ainsley Burke, Akiva Mintz, Mike Schmidt, Eric Hauser, Yung-Yu Huang, Nadine Melhem, M Elizabeth Sublette, Jeffrey M Miller, J John Mann","doi":"10.1001/jamapsychiatry.2024.3543","DOIUrl":"10.1001/jamapsychiatry.2024.3543","url":null,"abstract":"<p><strong>Importance: </strong>Brain translocator protein 18k Da (TSPO) binding, a putative marker of neuroinflammatory processes (eg, gliosis), is associated with stress and elevated in depressed and suicidal populations. However, it is unclear whether neuroinflammation moderates the impact of daily life stress on suicidal ideation and negative affect, thereby increasing risk for suicidal behavior.</p><p><strong>Objective: </strong>To examine the association of TSPO binding in participants with depression with real-world daily experiences of acute stress-related suicidal ideation and negative affect, as well as history of suicidal behavior and clinician-rated suicidal ideation.</p><p><strong>Design, setting, and participants: </strong>Data for this cross-sectional study were collected from June 2019 through July 2023. Procedures were conducted at a hospital-based research center in New York, New York. Participants were recruited via clinical referrals, the Columbia University research subject web portal, and from responses to internet advertisements. Of 148 participants who signed informed consent for study protocols, 53 adults aged 18 to 60 years who met DSM-5 diagnostic criteria for current major depressive disorder completed procedures with approved data and were enrolled. Participants were free of schizophrenia spectrum disorders, active physical illness, cognitive impairment, and substance intoxication or withdrawal at the time of scan.</p><p><strong>Exposures: </strong>All participants underwent positron emission tomography imaging of TSPO binding with 11C-ER176 and concurrent arterial blood sampling.</p><p><strong>Main outcome and measures: </strong>A weighted average of 11C-ER176 total distribution volume (VT) was computed across 11 a priori brain regions and made up the primary outcome measure. Clinician-rated suicidal ideation was measured via the Beck Scale for Suicidal Ideation (BSS). A subset of participants (n = 21) completed 7 days of ecological momentary assessment (EMA), reporting daily on suicidal ideation, negative affect, and stressors.</p><p><strong>Results: </strong>In the overall sample of 53 participants (mean [SD] age, 29.5 [9.8] years; 37 [69.8%] female and 16 [30.2%] male), 11C-ER176 VT was associated at trend levels with clinician-rated suicidal ideation severity (β, 0.19; 95% CI, -0.03 to 0.39; P = .09) and did not differ by suicide attempt history (n = 15; β, 0.18; 95% CI, -0.04 to 0.37; P = .11). Exploratory analyses indicated that presence of suicidal ideation (on BSS or EMA) was associated with higher 11C-ER176 VT (β, 0.21; 95% CI, 0.01 to 0.98; P = .045). In 21 participants who completed EMA, 11C-ER176 VT was associated with greater suicidal ideation and negative affect during EMA periods with stressors compared with nonstress periods (β, 0.12; SE, 0.06; 95% CI, 0.01 to 0.23; P = .03 and β, 0.19; SE, 0.06; 95% CI, 0.08 to 0.30; P < .001, respectively).</p><p><strong>Conclusion and relevance: </strong>TSPO bindi","PeriodicalId":14800,"journal":{"name":"JAMA Psychiatry","volume":" ","pages":"85-93"},"PeriodicalIF":22.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1001/jamapsychiatry.2024.3592
Hugo Bottemanne, Lucie Joly
{"title":"How the Paternal Brain Is Wired by Pregnancy.","authors":"Hugo Bottemanne, Lucie Joly","doi":"10.1001/jamapsychiatry.2024.3592","DOIUrl":"10.1001/jamapsychiatry.2024.3592","url":null,"abstract":"","PeriodicalId":14800,"journal":{"name":"JAMA Psychiatry","volume":" ","pages":"8-9"},"PeriodicalIF":22.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-18DOI: 10.1001/jamapsychiatry.2024.3996
Lori L. Davis, Saloni Behl, Daniel Lee, Hui Zeng, Taisa Skubiak, Shelley Weaver, Nanco Hefting, Klaus Groes Larsen, Mary Hobart
ImportanceNew pharmacotherapy options are needed for posttraumatic stress disorder (PTSD).ObjectiveTo investigate the efficacy, safety, and tolerability of brexpiprazole and sertraline combination treatment (brexpiprazole + sertraline) compared with sertraline + placebo for PTSD.Design, Setting, and ParticipantsThis was a parallel-design, double-blind, randomized clinical trial conducted from October 2019 to August 2023. The study had a 1-week, placebo run-in period followed by an 11-week, double-blind, randomized, active-controlled, parallel-arm period (with 21-day follow-up) and took place at 86 clinical trial sites in the US. Adult outpatients with PTSD were enrolled (volunteer sample).InterventionsOral brexpiprazole 2 to 3 mg per day (flexible dose) + sertraline 150 mg per day or sertraline 150 mg per day + placebo (1:1 ratio) for 11 weeks.Main Outcomes and MeasuresThe primary end point was change in Clinician-Administered PTSD Scale for <jats:italic>DSM-5</jats:italic> (CAPS-5) total score (which measures the severity of 20 PTSD symptoms) from randomization (week 1) to week 10 for brexpiprazole + sertraline vs sertraline + placebo. Safety assessments included adverse events.ResultsA total of 1327 individuals were assessed for eligibility. After 878 screen failures, 416 participants (mean [SD] age, 37.4 [11.9] years; 310 female [74.5%]) were randomized. Completion rates were 137 of 214 participants (64.0%) for brexpiprazole + sertraline and 113 of 202 participants (55.9%) for sertraline + placebo. At week 10, brexpiprazole + sertraline demonstrated statistically significant greater improvement in CAPS-5 total score (mean [SD] at randomization, 38.4 [7.2]; LS mean [SE] change, −19.2 [1.2]; n = 148) than sertraline + placebo (randomization, 38.7 [7.8]; change, −13.6 [1.2]; n = 134), with LS mean difference, −5.59 (95% CI, −8.79 to −2.38; <jats:italic>P</jats:italic> &lt; .001). All key secondary and other efficacy end points were also met. Treatment-emergent adverse events with incidence of 5% or greater for brexpiprazole + sertraline (and corresponding incidences for sertraline + placebo) were nausea (25 of 205 [12.2%] and 23 of 196 [11.7%]), fatigue (14 of 205 [6.8%] and 8 of 196 [4.1%]), weight increase (12 of 205 [5.9%] and 3 of 196 [1.5%]), and somnolence (11 of 205 [5.4%] and 5 of 196 [2.6%]). Discontinuation rates due to adverse events were 8 of 205 participants (3.9%) for brexpiprazole + sertraline and 20 of 196 participants (10.2%) for sertraline + placebo.Conclusions and RelevanceResults of this randomized clinical trial show that brexpiprazole + sertraline combination treatment statistically significantly improved PTSD symptoms vs sertraline + placebo, indicating its potential as a new efficacious treatment for PTSD. Brexpiprazole + sertraline was tolerated by most participants, with a safety profile consistent with that of brexpiprazole in approved indications.Trial RegistrationClinicalTrials.gov Identifier: <jats:ext-link x
{"title":"Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder","authors":"Lori L. Davis, Saloni Behl, Daniel Lee, Hui Zeng, Taisa Skubiak, Shelley Weaver, Nanco Hefting, Klaus Groes Larsen, Mary Hobart","doi":"10.1001/jamapsychiatry.2024.3996","DOIUrl":"https://doi.org/10.1001/jamapsychiatry.2024.3996","url":null,"abstract":"ImportanceNew pharmacotherapy options are needed for posttraumatic stress disorder (PTSD).ObjectiveTo investigate the efficacy, safety, and tolerability of brexpiprazole and sertraline combination treatment (brexpiprazole + sertraline) compared with sertraline + placebo for PTSD.Design, Setting, and ParticipantsThis was a parallel-design, double-blind, randomized clinical trial conducted from October 2019 to August 2023. The study had a 1-week, placebo run-in period followed by an 11-week, double-blind, randomized, active-controlled, parallel-arm period (with 21-day follow-up) and took place at 86 clinical trial sites in the US. Adult outpatients with PTSD were enrolled (volunteer sample).InterventionsOral brexpiprazole 2 to 3 mg per day (flexible dose) + sertraline 150 mg per day or sertraline 150 mg per day + placebo (1:1 ratio) for 11 weeks.Main Outcomes and MeasuresThe primary end point was change in Clinician-Administered PTSD Scale for <jats:italic>DSM-5</jats:italic> (CAPS-5) total score (which measures the severity of 20 PTSD symptoms) from randomization (week 1) to week 10 for brexpiprazole + sertraline vs sertraline + placebo. Safety assessments included adverse events.ResultsA total of 1327 individuals were assessed for eligibility. After 878 screen failures, 416 participants (mean [SD] age, 37.4 [11.9] years; 310 female [74.5%]) were randomized. Completion rates were 137 of 214 participants (64.0%) for brexpiprazole + sertraline and 113 of 202 participants (55.9%) for sertraline + placebo. At week 10, brexpiprazole + sertraline demonstrated statistically significant greater improvement in CAPS-5 total score (mean [SD] at randomization, 38.4 [7.2]; LS mean [SE] change, −19.2 [1.2]; n = 148) than sertraline + placebo (randomization, 38.7 [7.8]; change, −13.6 [1.2]; n = 134), with LS mean difference, −5.59 (95% CI, −8.79 to −2.38; <jats:italic>P</jats:italic> &amp;lt; .001). All key secondary and other efficacy end points were also met. Treatment-emergent adverse events with incidence of 5% or greater for brexpiprazole + sertraline (and corresponding incidences for sertraline + placebo) were nausea (25 of 205 [12.2%] and 23 of 196 [11.7%]), fatigue (14 of 205 [6.8%] and 8 of 196 [4.1%]), weight increase (12 of 205 [5.9%] and 3 of 196 [1.5%]), and somnolence (11 of 205 [5.4%] and 5 of 196 [2.6%]). Discontinuation rates due to adverse events were 8 of 205 participants (3.9%) for brexpiprazole + sertraline and 20 of 196 participants (10.2%) for sertraline + placebo.Conclusions and RelevanceResults of this randomized clinical trial show that brexpiprazole + sertraline combination treatment statistically significantly improved PTSD symptoms vs sertraline + placebo, indicating its potential as a new efficacious treatment for PTSD. Brexpiprazole + sertraline was tolerated by most participants, with a safety profile consistent with that of brexpiprazole in approved indications.Trial RegistrationClinicalTrials.gov Identifier: <jats:ext-link x","PeriodicalId":14800,"journal":{"name":"JAMA Psychiatry","volume":"53 1","pages":""},"PeriodicalIF":25.8,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142841809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-18DOI: 10.1001/jamapsychiatry.2024.4105
M. Catalina Camacho, Rebecca F. Schwarzlose, Michael T. Perino, Alyssa K. Labonte, Sanju Koirala, Deanna M. Barch, Chad M. Sylvester
ImportanceThe brain enters distinct activation states to support differential cognitive and emotional processes, but little is known about how brain activation states differ in youths with clinical anxiety.ObjectiveTo characterize brain activation states during socioemotional processing (movie stimuli) and assess associations between state characteristics and movie features and anxiety symptoms.Design, Setting, and ParticipantsThe Healthy Brain Network is an ongoing cross-sectional study of individuals aged 5 to 21 years experiencing difficulties in school, of whom approximately 45% met criteria for a lifetime anxiety disorder diagnosis. Data used in this study are from the first 9 releases (collected in a nonclinical research setting in the New York City metropolitan area from 2015 to 2020) and include 620 youths aged 5 to 15 years (53% of whom met criteria for a lifetime anxiety disorder diagnosis) who watched an emotional video during functional magnetic resonance imaging and completed questionnaires and clinical evaluation. Of those with functional magnetic resonance imaging data, 432 youths aged 7 to 15 years also self-reported on anxiety symptoms. Data were processed and analyzed between February 2020 and August 2024.Main Outcomes and MeasuresA hidden Markov model was trained to identify brain activation states across participants during video watching. Time spent in each state and the moment-to-moment probability of being in each state were extracted. Videos were annotated for emotion-specific and nonspecific information using the EmoCodes system. Self-reported anxiety symptoms were assessed using the Screen for Child Anxiety Related Disorders. Time spent in each state across the video and during and outside of peaks in negative content correlated with generalized and social anxiety scores.ResultsAmong the 620 youths in the overall analysis, 369 were male and the mean (SD) age was 10.4 (2.8) years. In the anxiety symptom analysis, 263 of 432 youths were male and the mean (SD) age was 11.5 (2.2) years. Three brain activation states were identified: a high somatomotor activation state (state 1), a high cingulo-opercular network activation state (state 2), and a high ventral attention and default mode state (state 3). The probability of being in state 3 was correlated with video content that was more negative, quieter, and with less visual motion (ρ &lt; 0.08; <jats:italic>P</jats:italic> &lt; .001). Increased generalized anxiety was associated with greater time in state 3 (B, 0.10; 95% CI, 0.01 to 0.20; false discovery rate [FDR]–corrected <jats:italic>P</jats:italic> = .048) and less time in state 2 (B, −0.11; 95% CI, −0.21 to −0.02; FDR-corrected <jats:italic>P</jats:italic> = .048) when negative social cues were present.Conclusions and RelevanceYouths entered 3 distinct brain activation states during movie watching, and youths with anxiety spent more time in a state with high ventral attention and default activation during
{"title":"Youth Generalized Anxiety and Brain Activation States During Socioemotional Processing","authors":"M. Catalina Camacho, Rebecca F. Schwarzlose, Michael T. Perino, Alyssa K. Labonte, Sanju Koirala, Deanna M. Barch, Chad M. Sylvester","doi":"10.1001/jamapsychiatry.2024.4105","DOIUrl":"https://doi.org/10.1001/jamapsychiatry.2024.4105","url":null,"abstract":"ImportanceThe brain enters distinct activation states to support differential cognitive and emotional processes, but little is known about how brain activation states differ in youths with clinical anxiety.ObjectiveTo characterize brain activation states during socioemotional processing (movie stimuli) and assess associations between state characteristics and movie features and anxiety symptoms.Design, Setting, and ParticipantsThe Healthy Brain Network is an ongoing cross-sectional study of individuals aged 5 to 21 years experiencing difficulties in school, of whom approximately 45% met criteria for a lifetime anxiety disorder diagnosis. Data used in this study are from the first 9 releases (collected in a nonclinical research setting in the New York City metropolitan area from 2015 to 2020) and include 620 youths aged 5 to 15 years (53% of whom met criteria for a lifetime anxiety disorder diagnosis) who watched an emotional video during functional magnetic resonance imaging and completed questionnaires and clinical evaluation. Of those with functional magnetic resonance imaging data, 432 youths aged 7 to 15 years also self-reported on anxiety symptoms. Data were processed and analyzed between February 2020 and August 2024.Main Outcomes and MeasuresA hidden Markov model was trained to identify brain activation states across participants during video watching. Time spent in each state and the moment-to-moment probability of being in each state were extracted. Videos were annotated for emotion-specific and nonspecific information using the EmoCodes system. Self-reported anxiety symptoms were assessed using the Screen for Child Anxiety Related Disorders. Time spent in each state across the video and during and outside of peaks in negative content correlated with generalized and social anxiety scores.ResultsAmong the 620 youths in the overall analysis, 369 were male and the mean (SD) age was 10.4 (2.8) years. In the anxiety symptom analysis, 263 of 432 youths were male and the mean (SD) age was 11.5 (2.2) years. Three brain activation states were identified: a high somatomotor activation state (state 1), a high cingulo-opercular network activation state (state 2), and a high ventral attention and default mode state (state 3). The probability of being in state 3 was correlated with video content that was more negative, quieter, and with less visual motion (ρ &amp;lt; 0.08; <jats:italic>P</jats:italic> &amp;lt; .001). Increased generalized anxiety was associated with greater time in state 3 (B, 0.10; 95% CI, 0.01 to 0.20; false discovery rate [FDR]–corrected <jats:italic>P</jats:italic> = .048) and less time in state 2 (B, −0.11; 95% CI, −0.21 to −0.02; FDR-corrected <jats:italic>P</jats:italic> = .048) when negative social cues were present.Conclusions and RelevanceYouths entered 3 distinct brain activation states during movie watching, and youths with anxiety spent more time in a state with high ventral attention and default activation during","PeriodicalId":14800,"journal":{"name":"JAMA Psychiatry","volume":"48 1","pages":""},"PeriodicalIF":25.8,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142841852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-10DOI: 10.1001/jamapsychiatry.2024.4387
Ethan G. Dutcher, Andrew D. Krystal
This randomized controlled trial secondary analysis examines the association between treatment expectancies and the relative efficacy of psilocybin compared with escitalopram for major depressive disorder.
{"title":"Treatment Expectancies and Psilocybin vs Escitalopram for Depression","authors":"Ethan G. Dutcher, Andrew D. Krystal","doi":"10.1001/jamapsychiatry.2024.4387","DOIUrl":"https://doi.org/10.1001/jamapsychiatry.2024.4387","url":null,"abstract":"This randomized controlled trial secondary analysis examines the association between treatment expectancies and the relative efficacy of psilocybin compared with escitalopram for major depressive disorder.","PeriodicalId":14800,"journal":{"name":"JAMA Psychiatry","volume":"29 1","pages":""},"PeriodicalIF":25.8,"publicationDate":"2024-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142797023","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01DOI: 10.1001/jamapsychiatry.2024.3419
Felix Teufel, Aastha Aggarwal, Lydia Chwastiak, Vikram Patel, Mohammed K Ali
<p><strong>Importance: </strong>Depression is a leading contributor to mental health burdens globally and in India, the world's most populous country. National-level evidence on health coverage for adults with depression in India is lacking.</p><p><strong>Objective: </strong>To estimate proportions of middle-aged and older adults with depression in India who used health care services, were diagnosed with depression, received treatment, and were in remission.</p><p><strong>Design, setting, and participants: </strong>This cross-sectional study used individual-level survey data from the 2017-2018 Longitudinal Ageing Study in India, which represents all 36 states and union territories of India. Data were collected from April 1, 2017, to December 31, 2018. The sample included adults 45 years or older with data on depression, health care service use, depression diagnosis and treatment, and sociodemographic characteristics. The response rates were 96% for households and 87% for individuals. Data were analyzed from January 15, 2024, to July 23, 2024.</p><p><strong>Main outcomes and measures: </strong>Major depressive episodes in the past 12 months were assessed using the Composite International Diagnostic Interview short-form symptom scale. We estimated self-reported health service use, depression diagnosis, and treatment for depression using sampling weights and stratified the data by rural vs urban residence. Participants were considered in remission if they received treatment and had fewer than 3 symptoms.</p><p><strong>Results: </strong>Among 65 121 participants, the median age was 57 years (IQR, 50-65 years); 53.3% were men and 46.7% were women. In terms of residence, 32.1% of participants resided in urban areas and 67.9% resided in rural areas. The weighted prevalence of depression was 8.6% (95% CI, 8.3%-8.9%). Of all participants with depression, 63.7% (95% CI, 62.0%-65.3%) had used any health services in the past year and 3.1% (95% CI, 2.6%-3.7%) had been diagnosed with depression; 1.6% (95% CI, 1.2%-2.0%) received some form of treatment (51% of those diagnosed) and 1.0% (95% CI, 0.7%-1.3%) were in remission (62% of those treated). The prevalence of depression was higher in rural areas (9.8% [95% CI, 9.4%-10.1%]) than in urban areas (6.2% [95% CI, 5.8%-6.7%]), although health service use, diagnosis, and treatment were lower in rural areas (61.2% [95% CI, 59.2%-63.1%], 2.6% [95% CI, 2.1%-3.3%], and 1.1% [95% CI, 0.8%-1.6%], respectively) than in urban areas (71.8% [95% CI, 68.5%-74.9%], 4.6% [95% CI, 3.5%-6.2%], and 3.0% [95% CI, 2.1%-4.4%], respectively). Among 29.6 million (95% CI, 28.6-30.6 million) middle-aged and older adults with depression across India, 29.1 million (95% CI, 28.2-30.1 million) were untreated, of whom 22.4 million (95% CI, 21.6-23.3 million) lived in rural areas.</p><p><strong>Conclusions and relevance: </strong>The findings of this cross-sectional study suggest that despite health service use by nearly two-thirds of middle-
{"title":"Depression Diagnosis, Treatment, and Remission Among Adults in India.","authors":"Felix Teufel, Aastha Aggarwal, Lydia Chwastiak, Vikram Patel, Mohammed K Ali","doi":"10.1001/jamapsychiatry.2024.3419","DOIUrl":"10.1001/jamapsychiatry.2024.3419","url":null,"abstract":"<p><strong>Importance: </strong>Depression is a leading contributor to mental health burdens globally and in India, the world's most populous country. National-level evidence on health coverage for adults with depression in India is lacking.</p><p><strong>Objective: </strong>To estimate proportions of middle-aged and older adults with depression in India who used health care services, were diagnosed with depression, received treatment, and were in remission.</p><p><strong>Design, setting, and participants: </strong>This cross-sectional study used individual-level survey data from the 2017-2018 Longitudinal Ageing Study in India, which represents all 36 states and union territories of India. Data were collected from April 1, 2017, to December 31, 2018. The sample included adults 45 years or older with data on depression, health care service use, depression diagnosis and treatment, and sociodemographic characteristics. The response rates were 96% for households and 87% for individuals. Data were analyzed from January 15, 2024, to July 23, 2024.</p><p><strong>Main outcomes and measures: </strong>Major depressive episodes in the past 12 months were assessed using the Composite International Diagnostic Interview short-form symptom scale. We estimated self-reported health service use, depression diagnosis, and treatment for depression using sampling weights and stratified the data by rural vs urban residence. Participants were considered in remission if they received treatment and had fewer than 3 symptoms.</p><p><strong>Results: </strong>Among 65 121 participants, the median age was 57 years (IQR, 50-65 years); 53.3% were men and 46.7% were women. In terms of residence, 32.1% of participants resided in urban areas and 67.9% resided in rural areas. The weighted prevalence of depression was 8.6% (95% CI, 8.3%-8.9%). Of all participants with depression, 63.7% (95% CI, 62.0%-65.3%) had used any health services in the past year and 3.1% (95% CI, 2.6%-3.7%) had been diagnosed with depression; 1.6% (95% CI, 1.2%-2.0%) received some form of treatment (51% of those diagnosed) and 1.0% (95% CI, 0.7%-1.3%) were in remission (62% of those treated). The prevalence of depression was higher in rural areas (9.8% [95% CI, 9.4%-10.1%]) than in urban areas (6.2% [95% CI, 5.8%-6.7%]), although health service use, diagnosis, and treatment were lower in rural areas (61.2% [95% CI, 59.2%-63.1%], 2.6% [95% CI, 2.1%-3.3%], and 1.1% [95% CI, 0.8%-1.6%], respectively) than in urban areas (71.8% [95% CI, 68.5%-74.9%], 4.6% [95% CI, 3.5%-6.2%], and 3.0% [95% CI, 2.1%-4.4%], respectively). Among 29.6 million (95% CI, 28.6-30.6 million) middle-aged and older adults with depression across India, 29.1 million (95% CI, 28.2-30.1 million) were untreated, of whom 22.4 million (95% CI, 21.6-23.3 million) lived in rural areas.</p><p><strong>Conclusions and relevance: </strong>The findings of this cross-sectional study suggest that despite health service use by nearly two-thirds of middle-","PeriodicalId":14800,"journal":{"name":"JAMA Psychiatry","volume":" ","pages":"1265-1269"},"PeriodicalIF":22.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01DOI: 10.1001/jamapsychiatry.2024.3403
Ian C Fischer, Peter J Na, Sheila T Nagamatsu, Dilip V Jeste, Brenda Cabrera-Mendoza, Janitza L Montalvo-Ortiz, John H Krystal, Renato Polimanti, Joel Gelernter, Robert H Pietrzak
{"title":"Posttraumatic Stress Disorder, Obesity, and Accelerated Epigenetic Aging Among US Military Veterans.","authors":"Ian C Fischer, Peter J Na, Sheila T Nagamatsu, Dilip V Jeste, Brenda Cabrera-Mendoza, Janitza L Montalvo-Ortiz, John H Krystal, Renato Polimanti, Joel Gelernter, Robert H Pietrzak","doi":"10.1001/jamapsychiatry.2024.3403","DOIUrl":"10.1001/jamapsychiatry.2024.3403","url":null,"abstract":"","PeriodicalId":14800,"journal":{"name":"JAMA Psychiatry","volume":" ","pages":"1276-1277"},"PeriodicalIF":22.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11581715/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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