- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00195598
Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder
April 1, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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
Intervention / Treatment
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
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Sao Paulo, Brazil, 04038-031
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Sao Paulo, Brazil, 04829-000
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Sao Paulo
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Jundiai, Sao Paulo, Brazil
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Santo Andre, Sao Paulo, Brazil, 09290-610
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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 |
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To evaluate the improvement of social function following therapy with Venlafaxine extended release (XR)in the Treatment of Panic Disorder in comparison to Paroxetine.
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Secondary Outcome Measures
Outcome Measure |
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Obtain the tolerability of using Venlafaxine extended release (XR) in the treatment of Panic Disorder in comparison to Paroxetine.
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Anxiety Disorders
- Disease
- Panic Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Cytochrome P-450 CYP2D6 Inhibitors
- Paroxetine
- Venlafaxine Hydrochloride
Other Study ID Numbers
- 0600B-101359
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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