Effectiveness Study to Compare Venlafaxine With Fluoxetine in the Treatment of Postmenopausal Women With Major Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Capital Medical University
Sponsor:
Information provided by (Responsible Party):
Gang Wang, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01824433
First received: April 1, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  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, we 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,fluoxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Capital Medical University:

Primary Outcome Measures:
  • change of 24-item Hamilton Rating Scale for Depression total score [ Time Frame: from baseline to endpoint(Week 8) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the mean change of HAMD-24 subscale score in items 10, 11, 12, 13 (anxiety and somatizations) at endpoint [ Time Frame: from baseline to endpoint(week 8) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • the mean change of Pain visual analog scale (Pain VAS) [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
  • the proportion of patients who discontinue due to lack of efficacy or intolerability [ Time Frame: From enrollment to endpoint (Week 8) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: venlafaxine Drug: venlafaxine,fluoxetine
venlafaxine 75-225mg qd fluoxetine 20-60mg qd
Other Names:
  • efexor
  • prozac
Active Comparator: fluoxetine Drug: venlafaxine,fluoxetine
venlafaxine 75-225mg qd fluoxetine 20-60mg qd
Other Names:
  • efexor
  • 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

Ages Eligible for Study:   50 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824433

Contacts
Contact: Rui Yang, M.D. 86-10-58303186 aries_ray@126.com

Locations
China, Beijing
Beijing Anding Hospital Recruiting
Beijing, Beijing, China, 100088
Contact: Ye Zhao    86-10-58303236    zzzy209@126.com   
Sponsors and Collaborators
Capital Medical University
Investigators
Principal Investigator: Gang Wang, M.D.,Ph.D Beijing Anding Hospital, Capital Medical University
  More Information

No publications provided

Responsible Party: Gang Wang, Head of Depression Center, Capital Medical University
ClinicalTrials.gov Identifier: NCT01824433     History of Changes
Other Study ID Numbers: VFPWMDD
Study First Received: April 1, 2013
Last Updated: April 1, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by 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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014