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Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients.

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marcelo Feijo Mello, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00725920
First received: July 28, 2008
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: June 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Posttraumatic Stress Disorder
Interventions: Drug: Topiramate
Drug: placebo control group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Topiramate patients receiving the active drug: topiramate. Patients will receive topiramate pills, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).
Control Group patients receiving placebo pills, that were identical to the pills content active drug, starting at 25 mg/d once daily, at night and increased in 25 mg weekly, as tolerated, until complete or nearly complete efficacy was achieved or until maximum dose allowed was reached (200 mg/d).

Participant Flow:   Overall Study
    Topiramate     Control Group  
STARTED     17     18  
COMPLETED     14     12  
NOT COMPLETED     3     6  
Lack of Efficacy                 3                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Topiramate patients receiving the active drug: topiramate
Control Group patients received pills content placebo, that were identical to the pills content active drug
Total Total of all reporting groups

Baseline Measures
    Topiramate     Control Group     Total  
Number of Participants  
[units: participants]
  17     18     35  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     18     35  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.7  ± 13.44     36.5  ± 7.97     37.54  ± 12.08  
Gender  
[units: participants]
     
Female     12     13     25  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
Brazil     17     18     35  
Clinician Administered Posttraumatic Scale (CAPS)  
[units: scores on a scale]
Mean ± Standard Deviation
     
Reexperiencing symptoms (CAPS-B)     23.05  ± 5.88     21.21  ± 7.15     22.84  ± 3.85  
Avoidance/numbing symptoms (CAPS-C)     31.58  ± 7.13     24.78  ± 11.30     28.6  ± 4.79  
Hyperarousal symptoms (CAPS-D)     24.11  ± 5.69     20.14  ± 8.29     22.03  ± 3.8  
Total CAPS     79.64  ± 12.03     64.33  ± 22     72.43  ± 16.73  



  Outcome Measures

1.  Primary:   Clinician Administered Posttraumatic Stress Disorder Scale   [ Time Frame: 12 week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Marcelo F Mello
Organization: Federal University of Sao Paulo
phone: 55 11 50822860
e-mail: mf-mello@uol.com.br


No publications provided by Federal University of São Paulo

Publications automatically indexed to this study:

Responsible Party: Marcelo Feijo Mello, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00725920     History of Changes
Other Study ID Numbers: TopirPTSD
Study First Received: July 28, 2008
Results First Received: June 1, 2010
Last Updated: August 5, 2014
Health Authority: Brazil: National Committee of Ethics in Research