Loading clinical trials...

A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia

NCT02873208•Alkermes, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Agrees to use an acceptable method of contraception for the duration of the study
•Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
•Additional criteria may apply

Exclusion Criteria

•Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
•Subject has a positive test for drugs of abuse at study entry
•Subject is pregnant, planning to become pregnant, or breastfeeding during the study
•Additional criteria may apply

Locations (45)

Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Springdale, Arkansas, United States

Alkermes Investigational Site

Anaheim, California, United States

Alkermes Investigational Site

Cerritos, California, United States

Alkermes Investigational Site

Culver City, California, United States

Alkermes Investigational Site

Garden Grove, California, United States

Alkermes Investigational Site

Glendale, California, United States

Alkermes Investigational Site

Lemon Grove, California, United States

Alkermes Investigational Site

Long Beach, California, United States

Alkermes Investigational Site

Oakland, California, United States

Key Dates

Start Date

August 7, 2016

Primary Completion Date

October 17, 2019

Completion Date

October 17, 2019

Last Updated

July 21, 2021

Enrollment

266

ACTUAL participants

Conditions

Schizophrenia

Interventions

ALKS 3831

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Brain Stimulation to the Hippocampus in Schizophrenia

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques