Study Evaluating Effexor XR for Major Depression.

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225511
• Other study ID #: 0600B1-816
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 22, 2007
• Start date: June 2004

Study information

• Verified date: May 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

Study Evaluating Effexor XR for Major Depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Effexor XR

• Milnacipran

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.
Secondary	Difference of total score of HAM-D17 between baseline and final-on-therapy.
Secondary	Remission rate of HAM-D17 at the final-on-therapy.