Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder

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NCT00195598

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Study Location
Jundiai, Sao Paulo, , Brazil
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Panic Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Panic DisordersStudy Comparing Venlafaxine vs. Paroxetine in Panic Disorder NCT00195598
  1. Jundiai, Sao Paulo
  2. Santo Andre, Sao Paulo
  3. Sao Paulo,
  4. Sao Paulo,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder
Official Title  ICMJE Pilot Study of Venlafaxine Extended Release (XR) in the Treatment of Panic Disorder (PD) in Comparison to Paroxetine.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Panic Disorders
Intervention  ICMJE
  • Drug: VENLAFAXINE
  • Drug: Paroxetine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 16, 2005)		70
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195598
Other Study ID Numbers  ICMJE 0600B-101359
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Trial ManagerPfizer CT.gov Call Center
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP