Clinical Study of ALKS 3831 in Schizophrenia with Alcohol Use Disorder

Phase 1

Conditions: Schizophrenia with alcohol use disorder
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2014-001211-39-BG

Lead Sponsor: Alkermes, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

Inclusion Criteria

1. Has a BMI between 18.0 and 40.0 kg/m2, inclusive
2. Has a diagnosis of schizophrenia
3. Has a diagnosis of alcohol use disorder (AUD)
4. Has experienced an acute exacerbation of schizophrenia within the
past 6 months
5. Additional criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Is pregnant or breastfeeding
2. Had first lifetime psychotic episode less than 1 year before screening
or has experienced only a single lifetime psychotic episode
3. Has a known or suspected intolerance, allergy, or hypersensitivity to
olanzapine
4. Has current or pending legal charges with the potential for
incarceration
5. Has a positive drug screen for opiates
6. Additional criteria may apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of olanzapine coadministered with samidorphan (ALKS 3831) compared with olanzapine coadministered with placebo in schizophrenia with alcohol use disorder (AUD).;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability of ALKS 3831 in schizophrenia with AUD.;Primary end point(s): The primary efficacy endpoint is defined as the time from randomization to exacerbation of disease symptoms. ;Timepoint(s) of evaluation of this end point: The timepoints will be evaluated on specified visits per schedule of assessments. <br> <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Rate and number of subjects with events indicative of exacerbation of symptoms during the double-blind treatment period<br>- Change from baseline in PANSS total and sub-scale score during the double-blind treatment period<br>- Change from baseline in CGI-S score during the double-blind treatment period<br>- CGI-I score during the double-blind treatment period<br>- Complete response profile of drinking during the double-blind treatment period<br>- Change from baseline in VAS score for desire for alcohol during the double-blind treatment period;Timepoint(s) of evaluation of this end point: The timepoints will be evaluated on specified visits per schedule of assessments. <br> <br>