At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 765 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Cariprazine 1.5 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 Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Placebo and Cariprazine for Schizophrenia. Completed, enrolled 765 participants across 73 sites in 5 countries.
Detailed Summary
The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesIndia, Romania, Slovakia, Ukraine, United States
CollaboratorsGedeon Richter Ltd.
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartSep 2011
Primary CompletionSep 2014
TodayJul 2026
First PostedAug 8, 2011
Enrollment StartSep 27, 2011
Primary CompletionSep 3, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 14.9 years ago
Interventions
Placebodrug
Placebo was supplied in capsules.
Cariprazinedrug
Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.