Levetiracetam in Post-Traumatic Stress Disorder

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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