Levetiracetam in Post-Traumatic Stress Disorder

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Post-Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT00413296

Run by

Duke University

People needed

16

Starts

2005-11-01

Expected to finish

2008-03-01

Last updated by the study team

2014-07-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ages 18-65
• primary diagnosis of PTSD based on DSM-IV criteria and assessed by the MINI International Neuropsychiatric Interview (MINI)
• Davidson Trauma Scale (DTS) score of at least 40 on screening
• ability to provide written informed consent

You may not qualify if…

• any primary DSM-IV Axis I disorder other than PTSD
• substance abuse during the last 6 months
• a clinically unstable medical condition or clinically significant laboratory abnormalities
• suicide risk or serious suicide attempt during the last year
• concurrent use of psychotropic medications including benzodiazepines, barbiturates, antiepileptic drugs, antidepressants, buspirone, dietary supplements or herbal or homeopathic remedies with psychotropic effects
• recent (within the last 3 months) initiation of cognitive behavioral therapy
• failure of a previous trial of levetiracetam at 2000 mg/day
• pregnancy or lactation
• women of childbearing potential who are unwilling to practice an acceptable method of contraception

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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