Back to resultsStudy Comparing Venlafaxine vs. Paroxetine in Panic Disorder
Primary Purpose
Panic Disorders
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
VENLAFAXINE
Paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorders focused on measuring Panic Disorders
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00195598
First Posted
September 12, 2005
Last Updated
April 1, 2010
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00195598
Brief Title
Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder
Official Title
Pilot Study of Venlafaxine Extended Release (XR) in the Treatment of Panic Disorder (PD) in Comparison to Paroxetine.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorders
Keywords
Panic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
VENLAFAXINE
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Obtain the tolerability of using Venlafaxine extended release (XR) in the treatment of Panic Disorder in comparison to Paroxetine.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
Pfizer CT.gov Call Center
Official's Role
Study Director
Facility Information:
City
Jundiai
State/Province
Sao Paulo
Country
Brazil
City
Santo Andre
State/Province
Sao Paulo
ZIP/Postal Code
09290-610
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04038-031
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04829-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder
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