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Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder

Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Panic Disorders

Intervention: VENLAFAXINE (Drug); Paroxetine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Summary

The purpose of this pilot study is to evaluate the improvement in social function following therapy with venlafaxine extended release (XR) in the treatment of panic disorder (PD) in comparison to paroxetine. An additional purpose of this pilot study is to obtain the tolerability of using venlafaxine extended release (XR) in the treatment of panic disorder (PD) in comparison to paroxetine.

Clinical Details

Official title: Pilot Study of Venlafaxine Extended Release (XR) in the Treatment of Panic Disorder (PD) in Comparison to Paroxetine.

Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To evaluate the improvement of social function following therapy with Venlafaxine extended release (XR)in the Treatment of Panic Disorder in comparision to Paroxetine.

Secondary outcome: Obtain the tolerability of using Venlafaxine extended release (XR) in the treatment of Panic Disorder in comparision to Paroxetine.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Meet DSM IV criteria for Panic Disorder (with or without agoraphobia) for at least 3

months before study day 1.

- Have a minimum of 8 full-symptom panic attacks during the 4 weeks before the screening

visit.

- Provide a written informed consent

Exclusion Criteria:

- Treatment with Venlafaxine within 6 months of study day 1, as well Paroxetine

- Known hypersensitivity to Venlafaxine or related compounds as well to Paroxetine.

- Psychopharmacologic drugs within 14 days of study day 1

Locations and Contacts

Sao Paulo 04038-031, Brazil

Sao Paulo 04829-000, Brazil

Santo Andre, Sao Paulo 09290-610, Brazil

Jundiai, Sao Paulo, Brazil

Additional Information

Starting date: January 2005
Ending date: April 2006
Last updated: December 18, 2007

Page last updated: June 20, 2008

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