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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT02746367
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with BDI, BDII, or MDD, confirmed with the Structured Clinical Interview for DSM-5 (SCID).
* Currently depressed for ≥4 weeks and ≤104 weeks, without psychotic features,
* MADRS score ≥ 20 (consistent with at least moderately-severe depression)
* YMRS score ≤ 8 (consistent with the absence of hypomanic symptoms)
Exclusion Criteria:
* At high risk for suicide, defined as a score ≥4 on item 10 of the MADRS
* Current depression has psychotic features, diagnosed with the SCID
* Meeting criteria for severe alcohol, cannabis, or THC use disorders, as defined by DSM-5 and confirmed by the SCID, in the past 3 months, or meeting criteria for other substance use disorders of any severity (eg. cocaine use disorder). For substances other than alcohol, cannabis, and opioids, a positive drug screen at both the screening and baseline visits is also exclusionary. Caffeine and nicotine use disorders of any severity will not be exclusionary.
* Diagnosis of borderline personality disorder, diagnosed with the Zanarini Rating Scale for Borderline Personality Disorder.
* Medical conditions with neurological sequelae (eg. stroke, brain cancer, multiple sclerosis, loss of consciousness \> 30 min, HIV)
* Severe chronic pain, at the discretion of the investigator
* Receiving treatment with high-potency immune-modulating medications, such as corticosteroids, chemotherapy, monoclonal antibodies, or disease-modifying agents for arthritis, multiple sclerosis
* Any acute unstable medical illness (at the discretion of the site investigator)
* In MDD patients: strong risk factors for bipolarity, including 1) short (1-3 day) mood elevations not meeting DSM-5 time criteria for hypomania; 2) a family history of BDI or BDII in a first-degree relative; and 3) a history of antidepressant-induced symptoms suggestive of bipolarity, particularly antidepressant-induced hypo/mania.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02746367
Study Brief:
Protocol Section:
NCT02746367