Major DepressionPhase 4NCT01824433
Comparison of Venlafaxine and Fluoxetine in the Treatment of Postmenopausal Women With Major Depression
A Phase 4 study testing venlafaxine and fluoxetine in people with Major Depression, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Major Depression
- What is being tested?
- venlafaxine and fluoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2013to 16 Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Major Depression
- Being tested
- venlafaxine, fluoxetine
- Keywords
- venlafaxine, fluoxetine, postmenopause, major depressive disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venlafaxineDrug
Also called Efexor
venlafaxine 75-225mg qd
fluoxetineDrug
Also called Prozac
fluoxetine 20-60mg qd
| Study group | Role | What they receive |
|---|---|---|
| venlafaxine | Active comparator | venlafaxine 75-225mg qd Receives: Drug: venlafaxine |
| fluoxetine | Active comparator | fluoxetine 20-60mg qd Receives: Drug: fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Improvement
change of 24-item Hamilton Rating Scale for Depression total score
Measured: from baseline to endpoint(Week 8)
Secondary outcomes (1)
Improvement of individual symptoms
the mean change of HAMD-24 subscale score in items 10, 11, 12, 13 (anxiety and somatizations) at endpoint
Measured: from baseline to endpoint(week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study start7 Mar 2013
- Primary completion16 Mar 2017
- Study completion16 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, MD, Capital Medical University
- Investigators
- Gang Wang, M.D.,Ph.D, Principal investigator, Beijing Anding Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824433
- Sponsor's protocol ID
- VFPWMDD
- Status last verified
- Sep 2017
- First submitted
- 1 Apr 2013
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34011310
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01824433
- Acronym / sponsor ID
- VFPWMDD
- Conditions
- Major Depression
- Keywords
- venlafaxine, fluoxetine, postmenopause, major depressive disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 7 Mar 2013 (actual)
- Primary completion
- 16 Mar 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| venlafaxine | Active comparator | Drug: venlafaxinevenlafaxine 75-225mg qd |
| fluoxetine | Active comparator | Drug: fluoxetinefluoxetine 20-60mg qd |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venlafaxineAlso: Efexorvenlafaxine 75-225mg qd | Drug | venlafaxine |
| fluoxetineAlso: Prozacfluoxetine 20-60mg qd | Drug | fluoxetine |
Primary outcome
Overall Improvement
Time frame: from baseline to endpoint(Week 8)
change of 24-item Hamilton Rating Scale for Depression total score
1 secondary outcome
Improvement of individual symptoms
Time frame: from baseline to endpoint(week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Derived from this study: PubMed 34011310Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Wang, M.D.,Ph.D principal investigator
Beijing Anding Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing venlafaxine and fluoxetine in people with Major Depression, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Improvement (time frame: from baseline to endpoint(Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01824433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.