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Sponsors and Collaborators: |
Duke University UCB |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00413296 |
The purpose of this study is to evaluate the short-term efficacy and safety of levetiracetam in post-traumatic stress disorder (PTSD) and to evaluate continuation effects of levetiracetam in preventing PTSD relapse. The hypothesis is that levetiracetam will be safe and effective in preventing relapse of PTSD.
Condition | Intervention | Phase |
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Post-Traumatic Stress Disorder |
Drug: levetiracetam Drug: Placebo Drug: Levetriracetam |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder |
Enrollment: | 16 |
Study Start Date: | November 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial.
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Drug: Placebo
Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.
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2: Active Comparator
Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
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Drug: levetiracetam
Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks
Drug: Levetriracetam
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.
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This is an investigator-initiated, single site study, consisting of two phases: 8 weeks of open label treatment with levetiracetam (500-2000 mg/day) in patients with PTSD, and in those who demonstrate at least minimal improvement, 12 weeks of randomized, double-blind treatment with either levetiracetam or matching placebo.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Jonathan Davidson, M.D. | Duke University |
Responsible Party: | Duke university Medical Center ( Dr. Wei Zhang ) |
Study ID Numbers: | 7031-05-4R0 |
Study First Received: | December 18, 2006 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00413296 History of Changes |
Health Authority: | United States: Institutional Review Board |
PTSD Anxiety Pharmacotherapy Levetiracetam Relapse prevention |
Nootropic Agents Anxiety Disorders Mental Disorders Piracetam Stress Disorders, Post-Traumatic |
Stress Etiracetam Neuroprotective Agents Anticonvulsants Stress Disorders, Traumatic |
Nootropic Agents Disease Physiological Effects of Drugs Stress Protective Agents Neuroprotective Agents Stress Disorders, Traumatic Pharmacologic Actions Pathologic Processes |
Anxiety Disorders Mental Disorders Therapeutic Uses Stress Disorders, Post-Traumatic Piracetam Etiracetam Central Nervous System Agents Anticonvulsants |