NCT00878748

Brief Summary

This primary purpose of this study is to assess the efficacy and safety of Effexor XR in preventing recurrence in Chinese patients with recurrent major depressive disorder (MDD) following a 1-year maintenance treatment after an 8-week acute treatment and a 6-month continuation treatment phases. The study will also collect data on the prevalence and pattern of co-morbid anxiety and somatic symptoms and their impact on the recurrence of depression.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

2.5 years

First QC Date

April 8, 2009

Last Update Submit

August 17, 2021

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • time from entering maintenance phase to recurrence of major depression

    12 months

Secondary Outcomes (1)

  • Patient Health Questionnaire(PHQ-15),Clinical Global Impressions(CGI),Visual Analogue Scale(VAS),Short Form Health Survey(SF-36)

    12 months

Study Arms (2)

A

EXPERIMENTAL

Effexor XR

Drug: Effexor XR

B

OTHER

Effexor XR discontinue

Other: Effexor XR discontinue

Interventions

Effexor XRDRUG
A
Effexor XR discontinueOTHER
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 9, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 20, 2021

Record last verified: 2021-08