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: 20.0Level: PTClassification code 10004939Term: Bipolar I disorderSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 21.1Level: PTClassification code 10039647Term: Schizophreniform disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2017-000497-11-IT
• Lead Sponsor: ALKERMES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-14
• Study Completion: 2021-12-01
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 426

Inclusion Criteria

For US sites, subject is more =16 and less 40 years of age at screening. For European sites, subject is more =18 and less40 years of age at screening
Subjects will have a body-mass index (BMI) of less 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 experienced an acute episode of mania as defined by DSM-5 within 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