Study Evaluating Venlafaxine ER in Adults With Panic Disorder

This study has been completed.

First Received: June 5, 2002 Last Updated: August 13, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00038896

Purpose

The primary objective of this study is to determine the efficacy, safety, and tolerability of a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III study.

Condition	Intervention	Phase
Panic Disorder	Drug: Venlafaxine ER	Phase III

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Double-blind, Placebo-controlled, Parallel-group, Flexible-dose Study of Venlafaxine Extended-release Capsules in Adult Outpatients With Panic Disorder

Resource links provided by NLM:

MedlinePlus related topics: Panic Disorder

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Further study details as provided by Wyeth:

Enrollment:	343
Study Start Date:	April 2001
Study Completion Date:	December 2002
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A male or female outpatient
Be at least 18 years of age and legal age of consent
Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1

Exclusion Criteria:

Treatment with venlafaxine (IR or ER) within 6 months of study day 1
Known hypersensitivity to venlafaxine (IR or ER) or related compounds
History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma [except basal cell epithelioma], uncontrolled hypertension)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038896

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Liebowitz MR, Asnis G, Mangano R, Tzanis E. A double-blind, placebo-controlled, parallel-group, flexible-dose study of venlafaxine extended release capsules in adult outpatients with panic disorder. J Clin Psychiatry. 2009 Apr;70(4):550-61. Epub 2009 Apr 7.

Study ID Numbers:	0600B5-353
Study First Received:	June 5, 2002
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00038896 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Panic
Disorder

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
Panic Disorder

Pathologic Processes
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Venlafaxine
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 22, 2009