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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT07220460
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) ≥ 18.0 to ≤ 40.0 kg/m\^2, inclusive.
* Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neuropsychiatric Interview (MINI 7.0.2), currently experiencing a depressive episode of at least 4 weeks and not exceeding 12 months.
* Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at screening or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF
* Participant with the following psychiatric history:
* No history of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.
* No lifetime history of schizophrenia, other psychotic disorders, dissociative disorders, or neurocognitive disorders.
* No history of moderate or severe substance use disorder (except nicotine) in the past 6 months prior to screening.
Exclusion Criteria:
* A total score greater than 12 on the Young Mania Rating Scale (YMRS) at baseline.
* History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
* A concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal impairment or disease (subjects with eGFR \< 30 mL/min), hepatic (including history of severe hepatic impairment), gastrointestinal, or neurological disorder (if there is a history of such disease but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with participation in the study, the subject may be included in the study).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07220460
Study Brief:
Protocol Section:
NCT07220460