M. Thase, Peter Zhang, A. Skuban, M. Hobart, C. Weiss, E. Weiller, J. Nelson
{"title":"辅助布雷哌唑治疗重度抑郁症的疗效:临床综述","authors":"M. Thase, Peter Zhang, A. Skuban, M. Hobart, C. Weiss, E. Weiller, J. Nelson","doi":"10.2174/1573400512999160901094451","DOIUrl":null,"url":null,"abstract":"Objective: To summarize efficacy data from two phase 2 and two phase 3 short-term, multicenter, randomized, double-blind, placebo-controlled studies of brexpiprazole adjunctive to antidepressant treatments (ADTs) in patients with major depressive disorder (MDD) with inadequate response to ADTs. Methods: Patients with MDD who were inadequate responders to 1–3 prior ADTs entered an 8-week single-blind prospective treatment phase on physician-determined ADT. Patients with inadequate response throughout the prospective treatment phase were randomized to receive either placebo or brexpiprazole (phase 2: flexible dosage 0.15–3.0 mg/day; phase 3: fixed-dosages 1, 2, or 3 mg/day) as adjunctive treatment to their ADT. The primary endpoint was change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week 6. Results: Phase 2 studies suggested brexpiprazole doses of 1–3 mg/day were effective as an adjunctive therapy. These observations were confirmed across the two phase 3 studies utilizing a pooled placebo group versus brexpiprazole 1, 2, and 3 mg/day and a pooled analysis of all four studies (brexpiprazole 1–3 mg/day). Greater improvements were observed in MADRS total score with brexpiprazole+ADT versus placebo+ADT (1 mg/day, p<0.01; 2 mg/day, p<0.01; 3 mg/day, p<0.001; brexpiprazole 1–3 mg/day, p<0.0001). Conclusion: Adjunctive brexpiprazole is an efficacious treatment option for patients with MDD and inadequate response to ADT. ClinicalTrials.gov: NCT00797966; NCT01052077; NCT01360632; NCT01360645.","PeriodicalId":51774,"journal":{"name":"Current Psychiatry Reviews","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2016-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2174/1573400512999160901094451","citationCount":"9","resultStr":"{\"title\":\"Efficacy of Adjunctive Brexpiprazole in Patients with Major Depressive Disorder: A Clinical Overview\",\"authors\":\"M. Thase, Peter Zhang, A. Skuban, M. Hobart, C. Weiss, E. Weiller, J. Nelson\",\"doi\":\"10.2174/1573400512999160901094451\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Objective: To summarize efficacy data from two phase 2 and two phase 3 short-term, multicenter, randomized, double-blind, placebo-controlled studies of brexpiprazole adjunctive to antidepressant treatments (ADTs) in patients with major depressive disorder (MDD) with inadequate response to ADTs. Methods: Patients with MDD who were inadequate responders to 1–3 prior ADTs entered an 8-week single-blind prospective treatment phase on physician-determined ADT. Patients with inadequate response throughout the prospective treatment phase were randomized to receive either placebo or brexpiprazole (phase 2: flexible dosage 0.15–3.0 mg/day; phase 3: fixed-dosages 1, 2, or 3 mg/day) as adjunctive treatment to their ADT. The primary endpoint was change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week 6. Results: Phase 2 studies suggested brexpiprazole doses of 1–3 mg/day were effective as an adjunctive therapy. These observations were confirmed across the two phase 3 studies utilizing a pooled placebo group versus brexpiprazole 1, 2, and 3 mg/day and a pooled analysis of all four studies (brexpiprazole 1–3 mg/day). Greater improvements were observed in MADRS total score with brexpiprazole+ADT versus placebo+ADT (1 mg/day, p<0.01; 2 mg/day, p<0.01; 3 mg/day, p<0.001; brexpiprazole 1–3 mg/day, p<0.0001). Conclusion: Adjunctive brexpiprazole is an efficacious treatment option for patients with MDD and inadequate response to ADT. ClinicalTrials.gov: NCT00797966; NCT01052077; NCT01360632; NCT01360645.\",\"PeriodicalId\":51774,\"journal\":{\"name\":\"Current Psychiatry Reviews\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2016-08-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.2174/1573400512999160901094451\",\"citationCount\":\"9\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current Psychiatry Reviews\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2174/1573400512999160901094451\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Psychiatry Reviews","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2174/1573400512999160901094451","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Efficacy of Adjunctive Brexpiprazole in Patients with Major Depressive Disorder: A Clinical Overview
Objective: To summarize efficacy data from two phase 2 and two phase 3 short-term, multicenter, randomized, double-blind, placebo-controlled studies of brexpiprazole adjunctive to antidepressant treatments (ADTs) in patients with major depressive disorder (MDD) with inadequate response to ADTs. Methods: Patients with MDD who were inadequate responders to 1–3 prior ADTs entered an 8-week single-blind prospective treatment phase on physician-determined ADT. Patients with inadequate response throughout the prospective treatment phase were randomized to receive either placebo or brexpiprazole (phase 2: flexible dosage 0.15–3.0 mg/day; phase 3: fixed-dosages 1, 2, or 3 mg/day) as adjunctive treatment to their ADT. The primary endpoint was change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week 6. Results: Phase 2 studies suggested brexpiprazole doses of 1–3 mg/day were effective as an adjunctive therapy. These observations were confirmed across the two phase 3 studies utilizing a pooled placebo group versus brexpiprazole 1, 2, and 3 mg/day and a pooled analysis of all four studies (brexpiprazole 1–3 mg/day). Greater improvements were observed in MADRS total score with brexpiprazole+ADT versus placebo+ADT (1 mg/day, p<0.01; 2 mg/day, p<0.01; 3 mg/day, p<0.001; brexpiprazole 1–3 mg/day, p<0.0001). Conclusion: Adjunctive brexpiprazole is an efficacious treatment option for patients with MDD and inadequate response to ADT. ClinicalTrials.gov: NCT00797966; NCT01052077; NCT01360632; NCT01360645.
期刊介绍:
Current Psychiatry Reviews publishes frontier reviews on all the latest advances on clinical psychiatry and its related areas e.g. pharmacology, epidemiology, clinical care, and therapy. The journal’s aim is to publish the highest quality review articles dedicated to clinical research in the field. The journal is essential reading for all clinicians, psychiatrists and researchers in psychiatry.