At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 732 enrolled
Drug / intervention
Placebo +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.
Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
In Brief
A Phase 2 clinical trial evaluating Placebo, Cariprazine, and 1 other intervention for Schizophrenia. Completed, enrolled 732 participants across 65 sites in 5 countries.
Detailed Summary
This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesIndia, Malaysia, Russia, Ukraine, United States
CollaboratorsGedeon Richter Ltd.
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2008
Enrollment StartJun 2008
Primary CompletionAug 2009
TodayJul 2026
First PostedJun 10, 2008
Enrollment StartJun 30, 2008
Primary CompletionAug 31, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.1 years ago
Interventions
Placebodrug
Placebo was supplied in capsules.
Cariprazinedrug
Cariprazine was supplied in capsules
Risperidonedrug
Risperidone was supplied in capsules