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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT00280293
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of bipolar I, II, not otherwise specified or cyclothymic disorders
* Currently depressed or mixed mood state
* Ages 18-70 years
* Men or women
* Self-reported cocaine use within 14 days prior to randomization
* English or Spanish speaking
* Baseline Hamilton Depression Rating Scale (HRSD17) score ≥ 10
Exclusion Criteria:
* Currently taking an enzyme inducing or inhibiting anticonvulsant (e.g. valproic acid, carbamazepine)
* Current severe psychotic features (e.g. daily auditory hallucinations, fixed delusions, severely disorganized thought processes) that require antipsychotic therapy, and that do not appear to be secondary to cocaine use
* Active suicidal ideation (plan and intent) or ≥2 attempts in past 12 months or any attempt in the past month
* Highly unstable medical condition
* Change in concomitant psychiatric medications (e.g. initiated antipsychotic) or in other substance abuse treatment (e.g. began intensive outpatient treatment) within 7 days prior to study entry
* Vulnerable populations (e.g. pregnant or nursing women, prisoners, mentally retarded)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00280293
Study Brief:
Protocol Section:
NCT00280293