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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT02048995
Eligibility Criteria:
Inclusion Criteria:
* Ages 18-50 years.
* DSM-IV BD Type I or II, current major depressive episode
* Stable-dosed antidepressant drug for 4 weeks or more only with concurrent antimanic drug.
* Controlled thyroid disease.
* Subjects with preexisting eye diseases will be included specific exceptions are described in the Exclusion Criteria.
* Able to provide informed consent.
* Stable minimum dose of antimanic drug for 4weeks or more.
* Stable unchanged psychotherapy for 16 weeks or more.
* Permitted drugs for sleep at low doses.
Exclusion Criteria:
* Certain specific eye diseases (retinal disease, untreated cataracts or macular degeneration)
* Photosensitizing drugs such as phenothiazines (chlorpromazine), antimalarial drugs, melatonin and hypericum.
* Acute psychosis (DSM-IV Criteria)
* Rapid cycling in the past 1 year
* Alcohol or substance abuse or dependence in the past 6 months.
* Current symptoms of hypomania or mania i.e. ManiaRatingScale=5
* Recent history of a suicide attempt (3 months) or active suicidal ideation (SIGH-ADS item H11=2 or more)
* Treatment with propranolol (Inderal), exogenous melatonin, chronic NSAIDS.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02048995
Study Brief:
Protocol Section:
NCT02048995