NCT03187769

Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

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

Detailed description

In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.

Conditions

• Schizophrenia
• Schizophreniform Disorders
• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	ALKS 3831	Olanzapine + samidorphan, daily oral dosing
DRUG	Olanzapine	Daily oral dosing

Timeline

• Start date: 2017-06-08
• Primary completion: 2021-12-01
• Completion: 2022-01-03
• First posted: 2017-06-15
• Last updated: 2023-01-19
• Results posted: 2023-01-19

Locations

57 sites across 12 countries: United States, Austria, Germany, Ireland, Israel, Italy, Poland, Russia, South Korea, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study