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Clinical Trials/NCT00225511
NCT00225511CompletedPhase 3

Phase III Multi-Center, Double-Blind, Comparative Study of Effexor XR for the Treatment of Depression

Wyeth is now a wholly owned subsidiary of Pfizer73 sites in 1 country590 target enrollmentStarted: June 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
590
Locations
73
Primary Endpoint
Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Study Evaluating Effexor XR for Major Depression.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
20 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients diagnosed with major depression based on DSM-IV-TR
  • •Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of "depressed mood" at the baseline.

Exclusion Criteria

  • •Patients with schizophrenia or any other psychotic disorder
  • •Patients with history or presence of bipolar disorder

Outcomes

Primary Outcomes

Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.

Secondary Outcomes

  • Difference of total score of HAM-D17 between baseline and final-on-therapy.
  • Remission rate of HAM-D17 at the final-on-therapy.

Investigators

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor Class
Industry

Study Sites (73)

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