A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | May 2014 |
| End Date: | February 1, 2017 |
A Phase 2, Efficacy, Safety and Tolerability Study of ALKS 3831 in Schizophrenia With Alcohol Use Disorder
This double-blind, randomized study will evaluate the efficacy, safety and tolerability of
ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
Inclusion Criteria:
- Has a BMI between 18.0 and 40.0 kg/m2, inclusive
- Has a diagnosis of schizophrenia
- Has a diagnosis of alcohol use disorder (AUD)
- Has experienced an acute exacerbation of schizophrenia within the past 6 months
- Additional criteria may apply
Exclusion Criteria:
- Is pregnant or breastfeeding
- Had first lifetime psychotic episode less than 1 year before screening or has
experienced only a single lifetime psychotic episode
- Has a known or suspected intolerance, allergy, or hypersensitivity to olanzapine
- Has current or pending legal charges with the potential for incarceration
- Has a positive drug screen for opiates
- Additional criteria may apply
We found this trial at
59
sites
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