Comparison of Venlafaxine and Fluoxetine in the Treatment of Postmenopausal Women With Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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 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.
    

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.

      Patients will be female, aged 55 or older, outpatient or inpatient status, with diagnosis of
      major depressive episode (single or recurrent) by DSM-IV, the current depressive episode
      within 1 years. The patients should also have HAMD-24 total score≥20,a HAMD-24 Item 1
      (depressed mood) score≥2 at screening and baseline.

      The eligible subjects will be randomly assigned to 1 of 2 treatment groups with 1:1
      allocation ratio: venlafaxine 75~225mg/d or fluoxetine 20~60mg/d. Treatment and observational
      duration will be 56 days (8 weeks).

      Primary efficacy measure will be assessed based on the decrease of HAMD-24 from baseline to
      endpoint. The secondary efficacy measures are change from baseline to endpoint in CGI-S,
      CGI-I, and Pain VAS et al.

      The safety in this study will be assessed by adverse event reporting, clinical laboratory
      measurements and physical examinations.
    

Intervention name(s): venlafaxine; fluoxetine
Intervention type(s): Drug; Drug
Intervention description(s): venlafaxine 75-225mg qd; fluoxetine 20-60mg qd
Other intervention name(s): Efexor; Prozac
Intervention MeSH terms: Fluoxetine; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: venlafaxine; fluoxetine; postmenopause; major depressive disorder