At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 426 enrolled
Drug / intervention
ALKS 3831 +1 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 Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults With Schizophrenia, Schizophreniform, or Bipolar I Disorder Who Are Early in Their Illness
In Brief
A Phase 3 clinical trial evaluating ALKS 3831 and Olanzapine for Schizophrenia and 2 related conditions. Completed, enrolled 426 participants across 57 sites in 12 countries.
Detailed Summary
This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Germany, Ireland, Israel, Italy, Poland, Russia, South Korea, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJun 2017
First PostedJun 2017
Primary CompletionDec 2021
Study CompletionJan 2022
TodayJul 2026
First PostedJun 15, 2017
Enrollment StartJun 8, 2017
Primary CompletionDec 1, 2021
Study CompletionJan 3, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.0 years ago
Interventions
ALKS 3831drug
Olanzapine + samidorphan, daily oral dosing
Olanzapinedrug
Daily oral dosing