At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 752 enrolled
Drug / intervention
Cariprazine +2 moredrug
Likely dose
Not stated in 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 Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone
In Brief
A Phase 3 clinical trial evaluating Cariprazine, Placebo, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 752 participants across 112 sites in 8 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 who have had an inadequate response to antidepressants alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesCanada, Czechia, Finland, Poland, Puerto Rico, Serbia, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartNov 2018
First PostedNov 2018
Primary CompletionSep 2021
TodayJul 2026
First PostedNov 13, 2018
Enrollment StartNov 10, 2018
Primary CompletionSep 6, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.6 years ago
Interventions
Cariprazinedrug
Cariprazine supplied in capsules
Placebodrug
Placebo supplied in capsules
Antidepressant Therapy (ADT)drug
ADT as prescribed by the physician per standard of care in clinical practice.