Study is 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.
- Conditions
- Schizophrenia, schizophreniform disorder or bipolar I disorderMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: PTClassification code 10039647Term: Schizophreniform disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: PTClassification code 10004939Term: Bipolar I disorderSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2017-000918-36-ES
- Lead Sponsor
- Alkermes Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
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 30 days prior to the study, during the study, and until 30 days after any study drug administration, 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 has completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307
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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
4. Subject is employed by Alkermes, the Investigator or study site (permanent, temporary contract worker, or designee responsible for the conduct of the study) or is immediate family1 of an Alkermes, clinical research organization, or study site employee
5. 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 long term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder.;Secondary Objective: None;Primary end point(s): Incidence of Adverse Events;Timepoint(s) of evaluation of this end point: At monthly visits 2, 3, 5, 6, 8, 9, 11, 12, 14, 15, 17, 18, 20, 21, 23, 24, quarterly visits 4, 7, 10, 13, 16, 19, 22, and EOT/Safetly f-u visits 25/26
- Secondary Outcome Measures
Name Time Method Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None