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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT01824433
Eligibility Criteria:
Inclusion Criteria:
* Female, aged 50 or older, memopausal.
* Meet DSM-IV criteria for current unipolar major depressive disorder.
* The total score of the HAMD-24 is at least 20 at screening and baseline.
* The current depressive episode within 1 year.
* If recurrent depression, the remission of previous episode is at least 5 years from the current episode.
* Providing informed consent form to participate in the study by patients or their legal representatives.
Exclusion Criteria:
* Current Axis I primary psychiatric diagnosis other than major depressive disorder.
* Substance abuse or dependence.
* Patients were also excluded if they had any medical condition that would contraindicate the use of venlafaxine or fluoxetine.
* Organic mental disease, including mental retardation.
* History of clinically significant disease, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require treatment during the study.
* Use of psychiatric agents within 5 days prior to randomization.
* Have proved no response to venlafaxin or fluoxetine by previous treatment.
* Participation in another clinical study within 4 weeks (or longer time according to the local requirement)
* Has received ECT or MECT within 3 months prior to randomization.
* Significant risk of suicidal and/or self-harm behaviors.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT01824433
Study Brief:
Protocol Section:
NCT01824433