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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT00927550
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of major depression (clinical diagnosis, guided by DSM-IV criteria).
* History of attempted suicide or deliberate self-harm in the previous 12 months.
* Inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode.
* Uncertainty about which treatment arm would be best for participant.
* Age 18 or above.
* Agreement between investigator and patient to enter the study.
Exclusion Criteria:
* In addition to major depression, a primary diagnosis of any concurrent Axis I disorder (according to DSM-IV criteria) will constitute an exclusion criterion; by contrast, any concurrent Axis II disorder (according to DSM-IV criteria) will not constitute an exclusion criterion.
* Previous exposure to lithium was associated with lack of efficacy or unwanted adverse reactions.
* Clinical conditions contraindicate the experimental treatment arm (for example thyroid or kidney disease or abnormalities).
* Pregnant/lactating women.
* Women of childbearing potential not practicing a reliable method of contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00927550
Study Brief:
Protocol Section:
NCT00927550