Phase 2
Completed N=255
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
Source: ClinicalTrials.gov NCT02161718 ↗Enrolled (actual)
255
Serious AEs
4.8%
Results posted
Oct 2021
Primary outcomePrimary: Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) — 25; 29; 87; 88 Participants — p=0.746
Summary
This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) |
25; 29; 87; 88 | 0.746 |
| SECONDARY Number of Events of Exacerbation of Disease (EEDS) |
35; 49 | 0.372 |
| SECONDARY Number and Percentage of Subjects With at Least 1 Level Decrease in World Health Organization (WHO) Drinking Risk Level From Baseline to Week 24 of the Double-blind Treatment (Study Week 27) |
45; 44; 66; 72 | 0.963 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02161718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.