NCT01824433

Comparison of Venlafaxine and Fluoxetine in the Treatment of Postmenopausal Women With Major Depression

Completed Phase 4 Last updated 14 September 2017

What this trial tests

Phase 4 trial testing venlafaxine in Major Depression in 189 participants. Completed in 16 March 2017.

Timeline

7 March 2013

Primary endpoint
16 March 2017

16 March 2017

Quick facts

Lead sponsor	Capital Medical University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	189
Start date	7 March 2013
Primary completion	16 March 2017
Estimated completion	16 March 2017
Sites	1 location across China

Drugs / interventions tested

• venlafaxine — full drug profile →
• fluoxetine (fluoxetine) — full drug profile →

Conditions studied

• Major Depression — all drugs for Major Depression →

Sponsor

Capital Medical University

Who can join

Adults 50 to 80, female only, with Major Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Venlafaxine vs. fluoxetine in postmenopausal women with major depressive disorder: an 8-week, randomized, single-blind, active-controlled study.
   Zhou J, Wang X, Feng L, Xiao L, et al · · 2021 · cited 17× · PMID 34011310 · DOI 10.1186/s12888-021-03253-8
2. Associations between reproductive health factors and sociodemographic characteristics and the severity of moderate to severe postmenopausal depression: a secondary analysis of randomized controlled trial data.
   Wang X, Zhang Q, Wang G, Zhou J. · · 2025 · PMID 40460394 · DOI 10.1097/gme.0000000000002543