Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder

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

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 Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sao Paulo, Brazil, 04038-031
      • Sao Paulo, Brazil, 04829-000
    • Sao Paulo
      • Jundiai, Sao Paulo, Brazil
      • Santo Andre, Sao Paulo, Brazil, 09290-610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
Obtain the tolerability of using Venlafaxine extended release (XR) in the treatment of Panic Disorder in comparison to Paroxetine.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Trial Manager, Pfizer CT.gov Call Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

April 1, 2006

Study Completion (ACTUAL)

April 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (ESTIMATE)

September 19, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2010

Last Update Submitted That Met QC Criteria

April 1, 2010

Last Verified

March 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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