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Completed

NCT Number: NCT00413296

Levetiracetam in Post-Traumatic Stress Disorder

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.

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Key information

Conditions

Post-traumatic Stress Disorder Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

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

Other names: Keppra

Placebo

Drug

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

Levetriracetam

Drug

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 names: Keppra

Primary outcomes

  1. Clinical Global Impressions - Improvement (CGI-I)

    Time frame: 20 wks

Secondary outcomes

  1. Davidson Trauma Scale (DTS)

    Time frame: 20 wks

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 20 wks

  3. Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: 20 wks

  4. 36-item Short Form Health Survey (SF-36)

    Time frame: 20 wks

  5. Pittsburgh Sleep Quality Index

    Time frame: 20 wks

  6. Work Productivity and Activity Improvement Questionnaire (WPAI)

    Time frame: 20 wks

  7. Sheehan Disability Inventory (SDI)

    Time frame: 20 wks

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • UCB Pharma

Registry information

Official study title

A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder

Acronym: PTSD

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Dec 19, 2006
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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