Status:
COMPLETED
Comparison of Venlafaxine and Fluoxetine in the Treatment of Postmenopausal Women With Major Depression
Lead Sponsor:
Capital Medical University
Conditions:
Major Depression
Eligibility:
FEMALE
50-80 years
Phase:
PHASE4
Brief Summary
Women are more prone to depression at certain points of the life cycle, although the etiologic and therapeutic implications remain largely unknown1,2. It is reported that pre- and postmenopausal women...
Detailed Description
The study is designed as a multicenter, rater-blind, parallel-group, active-controlled, flexible dose, randomized trial in postmenopausal women who are recently experiencing major depressive disorder....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2017
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT01824433
Start Date
March 7 2013
End Date
March 16 2017
Last Update
September 14 2017
Active Locations (1)
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1
Beijing Anding Hospital
Beijing, Beijing Municipality, China, 100088