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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT00852592
Eligibility Criteria:
Inclusion Criteria:
* Ages 18-65 years
* DSM-IV Criteria BD I or II depressive episode,
* SIGH-ADS \>20; duration \>2 weeks.
* Stable dose antidepressant drug \>8 weeks with concurrent antimanic drug
* Controlled thyroid disease
* Subjects with preexisting eye diseases will be included.
* Able to provide informed consent
* Stable minimum dose antimanic drug \>4weeks: lithium 0.5 mEq/L, divalproex Na 50 mcg/mL, olanzapine 5mg daily, carbamazepine 4mg/L; lamotrigine 100mg daily, risperidone 2mg daily, quetiapine 400 mg daily, ziprasidone 10 mg bid, and aripiprazole 5 mg qd.
* Stable unchanged psychotherapy for \>16weeks
Exclusion Criteria:
* The following eye diseases: retinal disease, cataract surgery and lens removal, macular degeneration,
* Taking photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
* Acute psychosis (DSM-IV Criteria)
* Rapid cycling in the past 1 year
* Obsessive compulsive disorder
* Alcohol or substance abuse or dependence in the past 6 months.
* MRS\>5
* Recent history of a suicide attempt (3 months) or active suicidal Ideation (SIGHADS item H11 \>2)
* Beta-adrenergic blockers, exogenous melatonin, chronic NSAIDS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00852592
Study Brief:
Protocol Section:
NCT00852592