Brexpiprazole as an adjunctive treatment in young adults with major depressive disorder who are in a school or work environment.
Major depressive disorder (MDD) is a common, debilitating disorder with substantial socioeconomic burden. Many patients with MDD experience symptoms that impair functioning and productivity, often negatively affecting work or educational pursuits. This Phase 3b open-label study evaluated adjunctive brexpiprazole in young adults with MDD, who were in work or study.



Young patients (18-35 years) with MDD (inadequate responders to 1-3 antidepressant treatments [ADT] for their current episode) received brexpiprazole 1-3mg/day (target dose, 2mg/day) adjunctive to the same stable dose of ADT for 12 weeks.



Depressive symptoms improved during treatment with adjunctive brexpiprazole (primary endpoint, least squares [LS] mean change from baseline in Montgomery-Åsberg Depression Rating Scale [MADRS] total score, -18.1 [p<0.0001]). Reductions from baseline in Sheehan Disability Scale Score (SDS; LS mean change -11.2 [p<0.0001]) and Work Limitations Questionnaire (WLQ; p<0.0001) indicated improvements in the effects of patients' symptoms on functioning (work/school, social life, and home responsibilities). Changes from baseline in additional measures supported improvements in patient functioning and depression symptoms. The most common adverse events were headache (21.3%), weight increase (17.0%), and somnolence (17.0%); reported rates of akathisia were low (6.4%). Clinically relevant increases in weight (≥7%) occurred in 10.5% of patients.



Open-label design; absence of comparator.



Brexpiprazole may represent an effective therapy for adjunctive treatment strategy of young adults with MDD who are working or studying. The observed improvements in work/school functioning in patients with MDD, whose depression was treated with ADT+brexpiprazole, suggests potential to reduce socioeconomic burden.
Duke University Medical Center Durham, University of North Carolina, Chapel Hill, NC, USA; Richard H Weisler Md And Association, MD, PA, Raleigh, NC, USA. Electronic address: rweisler@aol.com.
Richard H
RH
Weisler
Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.
Ai
A
Ota
Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.
Kana
K
Tsuneyoshi
Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ 08540, USA.
Pamela
P
Perry
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.
Emmanuelle
E
Weiller
Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ 08540, USA.
Ross A
RA
Baker
University of South Florida College of Medicine, Tampa, FL, USA.
David V
DV
Sheehan
D000293:Adolescent; D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004651:Employment / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000627:therapeutic use*; D013334:Students / Q000523:psychology; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D000928:Antidepressive Agents; D015363:Quinolones; D013876:Thiophenes; C000591922:brexpiprazole
Brexpiprazole; Functioning; Major depressive disorder; Work; Young adults