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 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT01944969
Eligibility Criteria:
Inclusion Criteria:
* The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
* The patient had MDD at entry in lead-in brexpiprazole studies, NCT01838681 / 14570A or NCT01837797 / 14571A, diagnosed according to DSM-IV-TR™.
* The patient agrees to protocol-defined use of effective contraception.
Exclusion Criteria:
* The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
* The patient has been diagnosed with a psychiatric disorder other than MDD during the lead-in studies NCT01838681 / 14570A or NCT01837797 / 14571A.
* The patient, in the opinion of the investigator or according to C-SSRS, is at significant risk of suicide.
* The patient has any relevant medical history or current presence of systemic disease.
* The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
* The patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01944969
Study Brief:
Protocol Section:
NCT01944969