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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT03427892
Eligibility Criteria:
Inclusion Criteria:
* Outpatient men and women ages 18-65
* Bipolar I or II disorders, currently depressed mood state based on a SCID for DSM-5; Mixed features in DSM-5 are allowed, but those with a Young Mania Rating Scale score ≥ 15 will be excluded
* Baseline MADRS score ≥ 20
Exclusion Criteria:
* Mood disorders other than bipolar I or II disorders (e.g., bipolar NOS, or cyclothymic disorders, schizophrenia, schizoaffective disorder, or unipolar depression based on the SCID), other disorders, e.g. anxiety disorders, will be allowed
* Current (last 14 days) treatment with an antipsychotic or antidepressant
* History of neuroleptic malignant syndrome or tardive dyskinesia
* Prior history of brexpiprazole use
* Vulnerable populations (e.g., pregnant, nursing, cognitively impaired, incarcerated)
* High risk for suicide defined as \> 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
* Severe or life-threatening medical condition, or laboratory or physical examination findings consistent with serious medical illness (e.g., dangerously abnormal electrolytes)
* Moderate or severe hepatic or renal impairment based on medical history and laboratory analyses
* Taking moderate or strong induces or inhibitors of CYP2D6 or CYP3A4
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03427892
Study Brief:
Protocol Section:
NCT03427892