A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.

Key facts

Study ID

NCT02694328

Run by

Alkermes, Inc.

People needed

561

Starts

2016-03-02

Expected to finish

2018-11-07

Last updated by the study team

2020-02-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has a body mass index (BMI) of 18.0-30.0 kg/m\^2, inclusive, at Visit 1 and Visit 2
• Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia
• Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1
• Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report
• Additional criteria may apply

You may not qualify if…

• Subject has any of the following psychiatric conditions per DSM-5 criteria:
• Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder
• Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study
• Drug-induced or toxic psychosis
• Any other psychiatric condition that could interfere with participation in the study
• Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator
• Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder
• Additional criteria may apply

Where it is running

• 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 — Long Beach, California, United States
• Alkermes Investigational Site — National City, California, United States
• Alkermes Investigational Site — Oakland, California, United States
• Alkermes Investigational Site — Oceanside, California, United States
• Alkermes Investigational Site — Orange, California, United States
• Alkermes Investigational Site — Pico Rivera, California, United States
• Alkermes Investigational Site — Redlands, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — San Diego, California, United States
• Alkermes Investigational Site — Temecula, California, United States
• Alkermes Investigational Site — Torrance, California, United States
• Alkermes Investigational Site — Washington D.C., District of Columbia, United States
• Alkermes Investigational Site — Lauderhill, Florida, United States
• Alkermes Investigational Site — Miami, Florida, United States
• Alkermes Investigational Site — North Miami, Florida, United States
• Alkermes Investigational Site — Oakland Park, Florida, United States
• Alkermes Investigational Site — Tampa, Florida, United States
• Alkermes Investigational Site — Atlanta, Georgia, United States
• Alkermes Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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