Levetiracetam in Post-Traumatic Stress Disorder

Duke University16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post-Traumatic Stress Disorder

Interventions

levetiracetamDRUG

Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks

PlaceboDRUG

Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.

LevetriracetamDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Clinical Global Impressions - Improvement (CGI-I)

Time frame: 20 wks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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