Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission

NCT ID: NCT00546494

Last Updated: 2007-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-03-31

Brief Summary

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This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Effexor® (Venlafaxine)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients meeting criteria for a diagnosis of major depression, single or recurrent episode as described by the DSM-IV manual (appendix 1).
* A HAM-D 17 total score of at least 16 at baseline (DSM-IV manual, appendix 2).
* Patients above 18 years of age who meet the eligibility requirements.

Exclusion Criteria

* Patients taking MAOI's within 2 weeks prior to the survey.
* Patients known to be suffering from bipolar disorder or schizophrenia.
* Patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy.
* Drug or alcohol dependence or abuse in the past 6 months per DSM IV criteria.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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0600B-101547

Identifier Type: -

Identifier Source: org_study_id