Study Evaluating Venlafaxine ER in Patients With Panic Disorder

This study has been completed.

First Received: September 4, 2002 Last Updated: August 13, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00044772

Purpose

The primary objective is to determine the efficacy, safety, and tolerability of venlafaxine extended release (ER) capsules in the treatment of outpatients with panic disorder (PD) in comparison to those of placebo.

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 Comparison of Venlafaxine Extended-release Capsules and Paroxetine in 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:	653
Study Start Date:	November 2001
Study Completion Date:	April 2003
Primary Completion Date:	April 2003 (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:

Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1
Have sufficient symptoms to require anxiolytic drug therapy
Have a score ≥4 on the Clinical Global Impressions Scale (CGI) severity of illness item at screening and baseline

Exclusion Criteria:

Known hypersensitivity to venlafaxine (IR or ER), related compounds, or paroxetine
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)
Clinically important abnormality on screening physical examination, vital signs, electrocardiogram (ECG), laboratory tests or urine drug screen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044772

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	0600B5-399
Study First Received:	September 4, 2002
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00044772 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 30, 2009