Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195598
First received: September 12, 2005
Last updated: April 1, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Panic Disorders
Drug: VENLAFAXINE
Drug: Paroxetine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Venlafaxine Extended Release (XR) in the Treatment of Panic Disorder (PD) in Comparison to Paroxetine.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 70
Study Start Date: January 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195598

Locations
Brazil
Jundiai, Sao Paulo, Brazil
Santo Andre, Sao Paulo, Brazil, 09290-610
Sao Paulo, Brazil, 04038-031
Sao Paulo, Brazil, 04829-000
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Trial Manager Pfizer CT.gov Call Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195598     History of Changes
Other Study ID Numbers: 0600B-101359
Study First Received: September 12, 2005
Last Updated: April 1, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Panic Disorders

Additional relevant MeSH terms:
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
Venlafaxine
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014