At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 347 enrolled
Drug / intervention
Samidorphan (Low Dose) +4 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 Phase 2, Randomized, Multicenter, Safety, Tolerability, and Dose-Ranging Study of Samidorphan, a Component of ALKS 3831, in Adults With Schizophrenia Treated With Olanzapine
In Brief
A Phase 2 clinical trial evaluating Samidorphan (Low Dose), Samidorphan (Medium Dose), and 3 other interventions for Schizophrenia. Completed, enrolled 347 participants across 61 sites in 3 countries.
Detailed Summary
This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Czechia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJul 2013
Primary CompletionDec 2014
Study CompletionMar 2015
TodayJul 2026
First PostedJul 19, 2013
Enrollment StartJun 1, 2013
Primary CompletionDec 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.0 years ago
Interventions
Samidorphan (Low Dose)drug
Tablets taken once daily
Samidorphan (Medium Dose)drug
Tablets taken once daily
Samidorphan (High Dose)drug
Tablets taken once daily
Placebodrug
Tablets taken once daily
Olanzapinedrug
Tablets taken once daily