Major Depression | Comparison of Venlafaxine and Fluoxetine in the Treatment of Postmenopausal Women With Major Depression
Major Depression research study
What is the primary objective of this study?
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 have a significant difference in response to some antidepressants, within a large clinical trial data set3, 4. A growing number of researches indicate that a woman's hormonal status may influence response to different forms of antidepressant medication. Specifically, younger women appeared to respond better to monoamine oxidase inhibitors (MAOIs) and selective serotonin reuptake inhibitor (SSRIs), whereas men and older women have tended to have relatively better responses to tricyclic antidepressants (TCAs) 1-5. One difference between these classes of antidepressants is that the SSRIs are strongly serotoninergic, whereas TCAs have predominantly noradrenergic effects. One pooled analysis 6 suggests that older women (age ≥ 50) tend to respond poorer to SSRI, while this phenomenen was not observed with venlafaxine. The antidepressive mechanism of venlafaxine that has both noradrenergic and serotonergic effects is superior to SSRIs. As a noradrenergic and serotonergic antidepressant, venlafaxinee has been demonstrated of significant advantages in response and remission rates compared with various SSRIs. As mentioned above, older women tend to have relatively better responses to TCAs which is predominantly noradrenergic antidepressant. Postmenopausal women with depression also would be predicted to respond better to an SSRI if administered along with hormone replacement therapy 6. This could be critical to understanding age difference in antidepressant responses across the life cycle because circulating estrogen levels may modulate central serotoninergic pathways. Therefore, it is presumed that antidepressants which enhance both serotonergic and noradrenergic neurotransmission, as venlafaxine, may be more effective than SSRIs for postmenopausal women with major depressive disorder.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:venlafaxinevenlafaxine 75-225mg qd
Drug:fluoxetinefluoxetine 20-60mg qd
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
venlafaxinevenlafaxine 75-225mg qd
fluoxetinefluoxetine 20-60mg qd
Start Date: March 7, 2013
Completed Date: March 16, 2017
Phase: Phase 4
Primary Outcome: Overall Improvement
Secondary Outcome: Improvement of individual symptoms
Study sponsors, principal investigator, and references
Principal Investigator: Gang Wang, M.D.,Ph.D
Lead Sponsor: Capital Medical University