Study Evaluating Long-Term Safety of Effexor XR in Patients With Major Depression.

Depression Clinical Trial

Official title:

Phase III Long-Term Administration Study of Effexor XR for the Treatment of Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225524
• Other study ID #: 0600B1-818
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 22, 2007
• Start date: September 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

Phase III long-term safety study of Effexor XR in patients with major depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients who complete the Phase III double-blind study (Protocol Number 0600B1-816)

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: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Effexor XR

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	Incidence of adverse events
Secondary	Quantitative data for laboratory data