At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 55 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Brexpiprazole 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Interventional, Open-label, Flexible-dose, Exploratory Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Major Depressive Disorder and Irritability. Completed, enrolled 55 participants across 15 sites.
Detailed Summary
To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a naturalistic setting of depressed patients with irritability.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Irritability
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartOct 2013
Primary CompletionJul 2014
TodayJul 2026
First PostedSep 16, 2013
Enrollment StartOct 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.8 years ago
Interventions
Brexpiprazoledrug
2-3 mg/day, once daily dose, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgement.