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...
Date First Received: September 12, 2005
Last Updated: December 18, 2007
Verified by: Wyeth, December 2007
Clinical Trial Phase: Phase 3 | Start Date: January 2005
Overall Status: Completed
Estimated Enrollment: 70
Brief Summary
Official Title: “Pilot Study of Venlafaxine Extended Release (XR) in the Treatment of Panic Disorder (PD) in Comparison to Paroxetine.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: VENLAFAXINE
- Drug: Paroxetine
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- Obtain the tolerability of using Venlafaxine extended release (XR) in the treatment of Panic Disorder in comparision to Paroxetine.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00195598
Study ID Number: 0600B-101359
ClinicalTrials.gov Identifier: NCT00195598
Health Authority: Brazil: National Health Surveillance Agency
Clinical Trials Authorship and Review
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