At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,022 enrolled
Drug / intervention
Cariprazine +2 moredrug
Likely dose
Cariprazine 4.5 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.
A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Cariprazine, Placebo, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 1,022 participants across 85 sites in 2 countries.
Detailed Summary
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesPuerto Rico, United States
CollaboratorsGedeon Richter Ltd.
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartNov 2012
Primary CompletionJun 2016
TodayJul 2026
First PostedOct 29, 2012
Enrollment StartNov 15, 2012
Primary CompletionJun 24, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.7 years ago
Interventions
Cariprazinedrug
Cariprazine capsules 1.5 to 4.5 mg/day
Placebodrug
Dose-matched placebo capsule once per day
Antidepressant Therapy (ADT)drug
ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.