Hannah S Ishimuro, Paula K Yanes-Lukin, Pablo H Goldberg, H Blair Simpson, Moira A Rynn
{"title":"Ketamine Treatment for Pediatric Refractory Obsessive: Five Open Label Cases.","authors":"Hannah S Ishimuro, Paula K Yanes-Lukin, Pablo H Goldberg, H Blair Simpson, Moira A Rynn","doi":"10.1089/cap.2024.0127","DOIUrl":null,"url":null,"abstract":"<p><p><b><i>Importance:</i></b> Selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy are the first-line treatments for pediatric obsessive-compulsive disorder (OCD) populations. Due to their limited effectiveness, additional treatment options are needed. A new potential pharmacological medication treatment avenue for OCD is intravenous (IV) ketamine. <b><i>Objective:</i></b> This study aimed to establish the feasibility, acceptability, and preliminary efficacy of an IV ketamine infusion for the treatment of refractory OCD in adolescents. <b><i>Design:</i></b> In this clinical pilot trial, every participant received IV ketamine infusion. Symptom severity and side effects were assessed daily for 2 weeks following the infusion. <b><i>Setting:</i></b> Study procedures were conducted at the New York State Psychiatric Institute, including a combination of in-person visits and phone calls. <b><i>Participants:</i></b> Five adolescents with OCD (age M, SD: 16.6 ± 1.5), who had previously failed trials of first-line treatments were enrolled. <b><i>Intervention:</i></b> All participants received an IV infusion of 0.5 mg/kg ketamine hydrochloride. <b><i>Main Outcomes and Measures:</i></b> A multimethod approach was applied, including physiological, self-report, and clinician-rated measures. To assess feasibility and acceptability, vital signs, electrocardiogram suicidality, self-reported adverse events, and dissociative symptoms were obtained. Obsessive-compulsive (OC) (Yale-Brown Obsessive Compulsive Challenge Scale, CY-BOCS) and depressive symptom severity, as well as global clinical impression, were assessed to investigate preliminary efficacy. <b><i>Results:</i></b> The mean (SD) pre- and 14-day posttreatment CY-BOCS were 29 (5.5) and 26.2 (5.6). There were no incidents of abnormal vital signs, mortality, or suicidal ideation in the 2 weeks following the infusion. All participants experienced mild dissociative symptoms in the 40 minutes after the IV ketamine infusion. Descriptively, OC symptom severity decreased immediately after the infusion but was not maintained over the course of the study. <b><i>Conclusions and Clinical Significance:</i></b> Ketamine is well-tolerated in adolescents with OCD and therefore appropriate for further efficacy testing. <b><i>Trial Registration:</i></b> ClinicalTrials.gov Identifier: NCT02422290.</p>","PeriodicalId":15277,"journal":{"name":"Journal of child and adolescent psychopharmacology","volume":" ","pages":""},"PeriodicalIF":1.5000,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of child and adolescent psychopharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1089/cap.2024.0127","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PEDIATRICS","Score":null,"Total":0}
引用次数: 0
Abstract
Importance: Selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy are the first-line treatments for pediatric obsessive-compulsive disorder (OCD) populations. Due to their limited effectiveness, additional treatment options are needed. A new potential pharmacological medication treatment avenue for OCD is intravenous (IV) ketamine. Objective: This study aimed to establish the feasibility, acceptability, and preliminary efficacy of an IV ketamine infusion for the treatment of refractory OCD in adolescents. Design: In this clinical pilot trial, every participant received IV ketamine infusion. Symptom severity and side effects were assessed daily for 2 weeks following the infusion. Setting: Study procedures were conducted at the New York State Psychiatric Institute, including a combination of in-person visits and phone calls. Participants: Five adolescents with OCD (age M, SD: 16.6 ± 1.5), who had previously failed trials of first-line treatments were enrolled. Intervention: All participants received an IV infusion of 0.5 mg/kg ketamine hydrochloride. Main Outcomes and Measures: A multimethod approach was applied, including physiological, self-report, and clinician-rated measures. To assess feasibility and acceptability, vital signs, electrocardiogram suicidality, self-reported adverse events, and dissociative symptoms were obtained. Obsessive-compulsive (OC) (Yale-Brown Obsessive Compulsive Challenge Scale, CY-BOCS) and depressive symptom severity, as well as global clinical impression, were assessed to investigate preliminary efficacy. Results: The mean (SD) pre- and 14-day posttreatment CY-BOCS were 29 (5.5) and 26.2 (5.6). There were no incidents of abnormal vital signs, mortality, or suicidal ideation in the 2 weeks following the infusion. All participants experienced mild dissociative symptoms in the 40 minutes after the IV ketamine infusion. Descriptively, OC symptom severity decreased immediately after the infusion but was not maintained over the course of the study. Conclusions and Clinical Significance: Ketamine is well-tolerated in adolescents with OCD and therefore appropriate for further efficacy testing. Trial Registration: ClinicalTrials.gov Identifier: NCT02422290.
期刊介绍:
Journal of Child and Adolescent Psychopharmacology (JCAP) is the premier peer-reviewed journal covering the clinical aspects of treating this patient population with psychotropic medications including side effects and interactions, standard doses, and research on new and existing medications. The Journal includes information on related areas of medical sciences such as advances in developmental pharmacokinetics, developmental neuroscience, metabolism, nutrition, molecular genetics, and more.
Journal of Child and Adolescent Psychopharmacology coverage includes:
New drugs and treatment strategies including the use of psycho-stimulants, selective serotonin reuptake inhibitors, mood stabilizers, and atypical antipsychotics
New developments in the diagnosis and treatment of ADHD, anxiety disorders, schizophrenia, autism spectrum disorders, bipolar disorder, eating disorders, along with other disorders
Reports of common and rare Treatment Emergent Adverse Events (TEAEs) including: hyperprolactinemia, galactorrhea, weight gain/loss, metabolic syndrome, dyslipidemia, switching phenomena, sudden death, and the potential increase of suicide. Outcomes research.