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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01824433
First Posted: April 4, 2013
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gang Wang, MD, Capital Medical University
  Purpose

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.


Condition Intervention Phase
Major Depression Drug: venlafaxine Drug: fluoxetine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 8-week, Rater-blind, Active-controlled, Randomized Study to Compare the Effectiveness of Venlafaxine With Fluoxetine in the Treatment of Postmenopausal Women With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Gang Wang, MD, Capital Medical University:

Primary Outcome Measures:
  • Overall Improvement [ Time Frame: from baseline to endpoint(Week 8) ]
    change of 24-item Hamilton Rating Scale for Depression total score


Secondary Outcome Measures:
  • Improvement of individual symptoms [ Time Frame: from baseline to endpoint(week 8) ]
    the mean change of HAMD-24 subscale score in items 10, 11, 12, 13 (anxiety and somatizations) at endpoint


Other Outcome Measures:
  • Pain [ Time Frame: from baseline to endpoint ]
    the mean change of Pain visual analog scale (Pain VAS)

  • safety outcome [ Time Frame: From enrollment to endpoint (Week 8) ]
    the proportion of patients who discontinue due to lack of efficacy or intolerability


Enrollment: 189
Actual Study Start Date: March 7, 2013
Study Completion Date: March 16, 2017
Primary Completion Date: March 16, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: venlafaxine
venlafaxine 75-225mg qd
Drug: venlafaxine
venlafaxine 75-225mg qd
Other Name: Efexor
Active Comparator: fluoxetine
fluoxetine 20-60mg qd
Drug: fluoxetine
fluoxetine 20-60mg qd
Other Name: Prozac

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824433


Locations
China, Beijing
Beijing Anding Hospital
Beijing, Beijing, China, 100088
Sponsors and Collaborators
Capital Medical University
Investigators
Principal Investigator: Gang Wang, M.D.,Ph.D Beijing Anding Hospital, Capital Medical University
  More Information

Responsible Party: Gang Wang, MD, Head of Depression Center, Capital Medical University
ClinicalTrials.gov Identifier: NCT01824433     History of Changes
Other Study ID Numbers: VFPWMDD
First Submitted: April 1, 2013
First Posted: April 4, 2013
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gang Wang, MD, Capital Medical University:
venlafaxine
fluoxetine
postmenopause
major depressive disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Venlafaxine Hydrochloride
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors