Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder

Panic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195598
• Other study ID #: 0600B-101359
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 1, 2010
• Start date: January 2005
• Est. completion date: April 2006

Study information

• Verified date: March 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder
• Panic Disorders

Intervention

Drug:
• VENLAFAXINE

• Paroxetine

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

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the improvement of social function following therapy with Venlafaxine extended release (XR)in the Treatment of Panic Disorder in comparison to Paroxetine.
Secondary	Obtain the tolerability of using Venlafaxine extended release (XR) in the treatment of Panic Disorder in comparison to Paroxetine.