Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195598

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 III

MedlinePlus related topics: Panic Disorder

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of Venlafaxine Extended Release (XR) in the Treatment of Panic Disorder (PD) in Comparison to Paroxetine.

Further study details as provided by Wyeth:

Primary Outcome 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 Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	January 2005
Study Completion Date:	April 2006

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

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

Locations

Brazil

Sao Paulo, Brazil, 04038-031

Sao Paulo, Brazil, 04829-000
Brazil, Sao Paulo

Santo Andre, Sao Paulo, Brazil, 09290-610

Jundiai, Sao Paulo, Brazil

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0600B-101359
Study First Received:	September 12, 2005
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00195598
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Wyeth:

Panic Disorders

Study placed in the following topic categories:

Panic Disorder
Anxiety Disorders
Mental Disorders

Venlafaxine
Paroxetine
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009