NCT00546494

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_4 depression

Status
completed

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

February 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
Last Updated

October 19, 2007

Status Verified

October 1, 2007

First QC Date

October 18, 2007

Last Update Submit

October 18, 2007

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment.

Secondary Outcomes (1)

  • Safety and tolerability will be assessed based on adverse events that occurred during the survey for all patients who received at least one dose of Effexor®.

Interventions

Effexor® (Venlafaxine)DRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 19, 2007

Study Start

February 1, 2004

Study Completion

March 1, 2005

Last Updated

October 19, 2007

Record last verified: 2007-10