Study to evaluate the efficacy of ALKS 3831 on body weight in young adults who have been recently diagnosed with Schizophrenia, Schizophreniform or Bipolar I Disorder

Phase 1

• Conditions: Schizophrenia, schizophreniform disorder or bipolar I disorder; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: PTClassification code 10039647Term: Schizophreniform disorderSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 20.0Level: PTClassification code 10004939Term: Bipolar I disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2017-000497-11-DE
• Lead Sponsor: Alkermes Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-13
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 425

Inclusion Criteria

For US sites, men and women =16 through <40 years of age at Screening.
For European non-US sites, men and women =18 through <40 years of age at Screening. Subjects will have a body-mass index (BMI) of <30.0 kg/m2 at Screening and Visit 2, with a Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder and meet Sponsor criteria for previous antipsychotic treatment and duration of illness. Subjects with bipolar I disorder must have been experiencing an acute episode of mania as defined by DSM-5 within the last 14 days prior to Visit 1.

Please refer to the protocol for full list of Inclusion Criteria
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 425
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects may be excluded based on diagnosis of additional psychiatric conditions, use of prohibited or contraindicated drugs and medications, pre-existing medical conditions, abnormal lab results during Screening, participation in any recent clinical trials or previous clinical trials of ALKS 3831 or samidorphan, pregnancy and relationship to an employee of the study Sponsor, CRO, Investigator, or study site.

Please refer to the protocol for full list of Exclusion Criteria

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 effect of ALKS 3831, compared to olanzapine, on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness;Secondary Objective: To evaluate the safety and tolerability of ALKS 3831 in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness;Primary end point(s): Percent change from baseline in body weight at week 12;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Proportion of subjects with =10% weight gain at week 12<br>- Proportion of subjects with =7% weight gain at week 12<br>- Change from baseline in waist circumference at Week 12<br>- Change from baseline in CGI-S score within the ALKS 3831 Group at Week 12;Timepoint(s) of evaluation of this end point: - Weight gain – week 12<br>