Levetiracetam in Post-Traumatic Stress Disorder (PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00413296
Recruitment Status : Completed
First Posted : December 19, 2006
Last Update Posted : July 21, 2014
UCB Pharma
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Drug: levetiracetam Drug: Placebo Drug: Levetriracetam Phase 2 Phase 3

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder
Study Start Date : November 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 1
Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial.
Drug: Placebo
Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.

Active Comparator: 2
Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
Drug: levetiracetam
Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks
Other Name: Keppra

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.
Other Name: Keppra

Primary Outcome Measures :
  1. Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: 20 wks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00413296

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
UCB Pharma
Principal Investigator: Jonathan Davidson, M.D. Duke University

Responsible Party: Duke University Identifier: NCT00413296     History of Changes
Other Study ID Numbers: Pro00007843
7031-05-4R0 ( Other Identifier: DUMC )
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: June 2010

Keywords provided by Duke University:
Relapse prevention

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs