A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
Status: | Completed |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 11/28/2018 |
Start Date: | March 2, 2016 |
End Date: | November 7, 2018 |
A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects
with schizophrenia.
with schizophrenia.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
50
sites
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