Major Depressive DisorderPhase 4NCT00474708

Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients

A Phase 4 study testing Effexor and SSRI in people with Major Depressive Disorder, run by Wyeth is now a wholly owned subsidiary of Pfizer at 26 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is an open-label, randomized, multi-center study conducted in a typical psychiatric outpatient practice in China. This study is intended to collect data on the efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional antidepressants in depressed patients that previously failed… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Effexor and SSRI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,151 participants
Where: 26 sitesChina
Study dates: Apr 2007to Mar 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Main Inclusion Criteria:

Males or females, 18 -65 years of age
Outpatients
Major depressive disorder based on DSM-IV criteria
The baseline score of 17-item HAM-D³17
Switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion
Provide written informed consent
If female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study.

Main Exclusion Criteria:

Hypersensitivity to venlafaxine;
Clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure
Alcohol or drug abuse within the last year
A recent history of myocardial infarction or unstable heart disease (within 6 months of baseline)
Bipolar disorder
For female, known or suspected pregnancy or breast feeding
Use of a monoamine oxidase inhibitor (MAOI) within 14 days of baseline; use of any investigational drug within 30 days of baseline.
Patients have prior use of venlafaxine or use of venlafaxine for the current episode.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

China26 sites

Study site
Beijing, Beijing Municipality, 100080
Study site
Beijing, Beijing Municipality, 100083
Study site
Beijing, Beijing Municipality, 100096
Study site
Changsha, Hunan, 410011
Study site
Guangzhou, Guangdong, 510000
Study site
Guangzhou, Guangdong, 510080
Study site
Guangzhou, Guangdong, 510150
Study site
Guangzhou, Guangdong, 510370
Study site
Hangzhou, Zhejiang, 310000
Study site
Hangzhou, Zhejiang, 310013
Study site
Huzhou, Zhejiang, 313000
Study site
Jinan, Shandong, 250014
Study site
Nanjing, Jiangsu, 210029
Study site
Shanghai, Shanghai Municipality, 200003
Study site
Shanghai, Shanghai Municipality, 200030
Study site
Shanghai, Shanghai Municipality, 200080
Study site
Shanghai, Shanghai Municipality, 200083
Study site
Shanghai, Shanghai Municipality, 200090
Study site
Shanghai, Shanghai Municipality, 200124
Study site
Shanghai, Shanghai Municipality, 201900
Study site
Shenyang, Liaoning, 110168
Study site
Suzhou, Zhejiang, 215008
Study site
Tianjin, Tianjin Municipality, 300350
Study site
Wuhan, Hubei, 430022
Study site
Xian, Shanxi, 710061
Study site
Zhengzhou, Henan, 450006

Other trials in China

About this study

Official title: The Efficacy of Venlafaxine XR (Efexor XR®) Versus SSRIs & Conventional Antidepressants in Depressed Patients Switched From Prior Antidepressants in Psychiatric Outpatient Care Settings in China

Conditions: Major Depressive Disorder
Being tested: Effexor, SSRI
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.

EffexorDrug
SSRIDrug

Study groups in NCT00474708
Study group	Role	What they receive
1	Experimental	1.Effexor XR Group Receives: Drug: Effexor
2	Active comparator	2.SSRI or Conventional Antidepressant Group Receives: Drug: SSRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Achieving Remission
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.
Measured: 12 weeks

Secondary outcomes (1)

Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Mar 2008

First posted17 May 2007 (estimated)
Study startApr 2007
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
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: None (open label)
Enrolment: 1,151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00474708
Sponsor's protocol ID: 0600B2-4418
Status last verified: Mar 2012
First submitted: 10 May 2007
Last updated: 5 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Venlafaxine XR (Efexor XR®) Versus SSRIs & Conventional Antidepressants in Depressed Patients Switched From Prior Antidepressants in Psychiatric Outpatient Care Settings in China
ClinicalTrials.gov ID: NCT00474708
Acronym / sponsor ID: 0600B2-4418
Conditions: Major Depressive Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,151 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 17 May 2007 (estimated)
Results: Posted 30 Apr 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Effexor1.Effexor XR Group
2	Active comparator	Drug: SSRI2.SSRI or Conventional Antidepressant Group

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Effexor	Drug	1
SSRI	Drug	2

Primary outcome

Number of Patients Achieving Remission
Time frame: 12 weeks
Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.

1 secondary outcome

Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 30 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Venlafaxine XR	791	734
SSRI or Conventional Antidepressant Group	367	342

Primary outcome: Number of Patients Achieving Remission

Time frame: 12 weeks. Number. Unit: participants

Measure	Venlafaxine XR n = 664	SSRI or Conventional Antidepressant Group n = 295
Value	554	207

Population analysed: The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Venlafaxine XR	3 of ?	418 of ?	Not reported
SSRI or Conventional Antidepressant Group	1 of ?	236 of ?	Not reported

Limitations and caveats (from the sponsor): 365 participants were assessed for safety. Certain demographic data (gender and age) is missing for one participant. Thereby resulting in the participant flow reflecting 364 participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

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Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
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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.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Effexor and SSRI in people with Major Depressive Disorder, run by Wyeth is now a wholly owned subsidiary of Pfizer at 26 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites 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?

Yes. Results are posted in the registry (first posted 30 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Achieving Remission (time frame: 12 weeks). 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 NCT00474708.

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 5 Mar 2012.