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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT04950868
Eligibility Criteria:
Inclusion Criteria:
* Outpatient woman between ages 18 - 45
* Within 6 months of delivery
* Have a DSM-5 diagnosis of MDD or BD I, BD II or other specified bipolar or related disorder with peripartum onset
* Have a score of \>18 on the 17-item Hamilton Depression Rating Scale (HDRS)
* Have a score of ≤12 Young Mania Rating Scale (YMRS) at both the screening and baseline visits
* Able to communicate in English
* Capable of providing informed consent
Exclusion Criteria:
* A diagnosis of schizophrenia spectrum or other psychotic disorders, obsessive-compulsive disorder, eating disorders, substance-related and addictive disorders
* At high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the HDRS)
* Receiving a psychotropic drug such a mood stabilizer, an antidepressant or a sedative/hypnotic.
* Receiving psychotherapy
* Have a physical illness that is a contraindication to the use of quetiapine, or who have a history of intolerance or nonresponse to quetiapine
* Pregnant or planning on becoming pregnant during the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04950868
Study Brief:
Protocol Section:
NCT04950868