Levetiracetam in Post-Traumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT00413296|
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : July 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Drug: levetiracetam Drug: Placebo Drug: Levetriracetam||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||March 2008|
Placebo Comparator: 1
Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial.
Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.
Active Comparator: 2
Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks
Other Name: Keppra
Tablets, 500 mg each (1-6 tablets/day) for 8 wks during the open label phase and for 12 wks during the 2nd phase of the study.
Other Name: Keppra
- Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: 20 wks ]
- Davidson Trauma Scale (DTS) [ Time Frame: 20 wks ]
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 20 wks ]
- Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: 20 wks ]
- 36-item Short Form Health Survey (SF-36) [ Time Frame: 20 wks ]
- Pittsburgh Sleep Quality Index [ Time Frame: 20 wks ]
- Work Productivity and Activity Improvement Questionnaire (WPAI) [ Time Frame: 20 wks ]
- Sheehan Disability Inventory (SDI) [ Time Frame: 20 wks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413296
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Jonathan Davidson, M.D.||Duke University|