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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT01416220
Eligibility Criteria:
Inclusion Criteria:
* men or women
* age of 18 years or older
* meet criteria for major depressive episode, and have a family history of bipolar disorder or completed suicide
Exclusion Criteria:
* subjects not able to give informed consent
* pregnant or breast-feeding women
* current panic disorder, post traumatic stress disorder or psychosis
* subjects with a history of mania or hypomania
* subjects with active substance abuse or dependence in the last 6 months
* current depressive episode less than 4 weeks or greater than 12 months in duration
* adequate trial of lithium or paroxetine (lithium level ≥ 0.6mmols/l; paroxetine 20mgs ≥ 5 weeks) for this episode of depression
* concurrent use of other antidepressants or augmenting agents for the treatment of depression
* clinically significant medical illness, in particular renal impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01416220
Study Brief:
Protocol Section:
NCT01416220