Study to evaluate the long term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, 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: EUCTR2017-000918-36-BG
• Lead Sponsor: Alkermes Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-09
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Subject is willing and able to give informed consent/assent as per local requirements
2. Subject agrees to use an acceptable method of contraception during the study and until 30 days after any study drug administration during, unless surgically sterile or post-menopausal
3. Subject has the potential to benefit from the administration of ALKS 3831, in the opinion of the Investigator
4. Subject met eligibility criteria and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307

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 494
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Subject has any finding that in the view of the investigator or medical monitor would compromise the safety of the subject or affect his/her ability to fulfill the protocol visit schedule or visit requirements
2. Subject has a positive drug screen for drugs of abuse at study entry
3. Subject is currently pregnant. breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified