Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT04186403
Eligibility Criteria:
Inclusion Criteria:
* Participants, who completed the last treatment visit of the previous double-blind brexpiprazole BPD trial and who, in the opinion of the investigator, could potentially benefit from administration of brexpiprazole for the treatment of BPD.
* Male or female outpatients, ages 18 to 65 years, inclusive, at the time of informed consent of the previous double-blind brexpiprazole BPD trial.
Exclusion Criteria:
* Sexually active males or females of childbearing potential (FOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. Male participants must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of investigational medicinal product (IMP).
* Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
* Participants who participated in a clinical trial within 90 days prior to screening/baseline (with the exception of a previous brexpiprazole double-blind BPD trial) or who participated in more than 2 clinical trials within a year prior to screening/baseline.
* Participants who develop a medically significant abnormality.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04186403
Study Brief:
Protocol Section:
NCT04186403