NCT03201757

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 523 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Conditions

• Schizophrenia
• Schizophreniform Disorder
• Bipolar I Disorder

Interventions

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

Timeline

• Start date: 2017-06-15
• Primary completion: 2023-09-06
• Completion: 2023-09-06
• First posted: 2017-06-28
• Last updated: 2024-09-26
• Results posted: 2024-09-26

Locations

85 sites across 13 countries: United States, Austria, Bulgaria, Ireland, Israel, Italy, Poland, Puerto Rico, Russia, Serbia, South Korea, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study