At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Brexpiprazole +1 moredrug
Likely dose
Brexpiprazole 3mgfrom 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.
A Phase 1, Multicenter, Randomized, Double-blind, Sequential Cohort, Placebo-controlled Trial to Assess the Safety and Tolerability of Ascending Multiple Oral Doses of Brexpiprazole as Adjunctive Therapy in the Treatment of Elderly Subjects With Major Depressive Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 22, 2012·Updated Feb 4, 2016
In Brief
A Phase 1 clinical trial evaluating Brexpiprazole and Placebo for Major Depressive Disorder. Completed, enrolled 18 participants across 4 sites.
Detailed Summary
The purpose of this study is to assess the safety and tolerability of ascending multiple oral doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedAug 2012
Primary CompletionMay 2013
TodayJul 2026
First PostedAug 22, 2012
Enrollment StartJul 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.9 years ago
Interventions
Brexpiprazoledrug
up to 3mg oral dose once daily
Placebodrug