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:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT06081634
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 and 40 years of age whose disease onset (first episode) is within the last 5 years.
* Fulfill diagnostic criteria for bipolar disorder (type I or type II) or schizoaffective disorder, bipolar type, according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-5) based on a semi-structured clinical interview.
* Patients in clinical remission or partial remission at the time of assessment, defined as scores ≤ 10 on the Young Mania Rating Scale (YMRS) (Young, 1978) and ≤ 14 points on the Hamilton Depression Rating Scale (HAMD) (Hamilton, 1960).
* Signed informed consent to participate in the study.
Exclusion Criteria:
* Estimated IQ less than 85.
* Any medical condition that may affect neuropsychological performance (such as neurological diseases).
* Presence of any comorbid psychiatric condition (except substance use/abuse).
* Patients who have received any type of psychological intervention in the 6 months prior to the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06081634
Study Brief:
Protocol Section:
NCT06081634