- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01824433
Comparison of Venlafaxine and Fluoxetine in the Treatment of Postmenopausal Women With Major Depression
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100088
- Beijing Anding Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: venlafaxine
venlafaxine 75-225mg qd
|
venlafaxine 75-225mg qd
Other Names:
|
Active Comparator: fluoxetine
fluoxetine 20-60mg qd
|
fluoxetine 20-60mg qd
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Improvement
Time Frame: from baseline to endpoint(Week 8)
|
change of 24-item Hamilton Rating Scale for Depression total score
|
from baseline to endpoint(Week 8)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
from baseline to endpoint(week 8)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: from baseline to endpoint
|
the mean change of Pain visual analog scale (Pain VAS)
|
from baseline to endpoint
|
safety outcome
Time Frame: From enrollment to endpoint (Week 8)
|
the proportion of patients who discontinue due to lack of efficacy or intolerability
|
From enrollment to endpoint (Week 8)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gang Wang, M.D.,Ph.D, Beijing Anding Hospital, Capital Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Cytochrome P-450 CYP2D6 Inhibitors
- Venlafaxine Hydrochloride
- Fluoxetine
Other Study ID Numbers
- VFPWMDD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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