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

NCT01824433 | Completed Phase 4 DMC

• 1 other identifier: VFPWMDD
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Major Depression

Keywords

venlafaxine; fluoxetine; postmenopause; major depressive disorder

Outcome Measures

Primary Outcomes (1)

• Overall Improvement

  change of 24-item Hamilton Rating Scale for Depression total score

  from baseline to endpoint(Week 8)

Secondary Outcomes (1)

• Improvement of individual symptoms

  from baseline to endpoint(week 8)

Other Outcomes (2)

• Pain

  from baseline to endpoint

• safety outcome

  From enrollment to endpoint (Week 8)

Study Arms (2)

venlafaxine

ACTIVE COMPARATOR

venlafaxine 75-225mg qd

Drug: venlafaxine

fluoxetine

ACTIVE COMPARATOR

fluoxetine 20-60mg qd

Drug: fluoxetine

Interventions

venlafaxine DRUG

venlafaxine 75-225mg qd

Also known as: Efexor

venlafaxine

fluoxetine DRUG

fluoxetine 20-60mg qd

Also known as: Prozac

fluoxetine

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Anding Hospital

Beijing, Beijing Municipality, 100088, China

Location

Related Publications (1)

• Zhou J, Wang X, Feng L, Xiao L, Yang R, Zhu X, Shi H, Hu Y, Chen R, Boyce P, Wang G. Venlafaxine vs. fluoxetine in postmenopausal women with major depressive disorder: an 8-week, randomized, single-blind, active-controlled study. BMC Psychiatry. 2021 May 19;21(1):260. doi: 10.1186/s12888-021-03253-8.

  PMID: 34011310 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Venlafaxine Hydrochloride; Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Propylamines

Study Officials

• Gang Wang, M.D.,Ph.D

  Beijing Anding Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Depression Center

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: March 7, 2013
• Primary Completion: March 16, 2017
• Study Completion: March 16, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)