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Levetiracetam in Post-Traumatic Stress Disorder (PTSD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413296
First Posted: December 19, 2006
Last Update Posted: July 21, 2014
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.
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Duke University
December 18, 2006
December 19, 2006
July 21, 2014
November 2005
September 2007   (Final data collection date for primary outcome measure)
Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: 20 wks ]
Clinical Global Impressions - Improvement (CGI-I)
Complete list of historical versions of study NCT00413296 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Davidson Trauma Scale (DTS)
  • Hospital Anxiety and Depression Scale (HADS)
  • Connor-Davidson Resilience Scale (CD-RISC)
  • 36-item Short Form Health Survey (SF-36)
  • Pittsburgh Sleep Quality Index
  • Work Producitvity and Activity Improvement Questionnaire (WPAI)
  • Sheehan Disability Inventory (SDI)
Not Provided
Not Provided
 
Levetiracetam in Post-Traumatic Stress Disorder
A Double-Blind Discontinuation Study of 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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
  • Drug: levetiracetam
    Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks
    Other Name: Keppra
  • Drug: Placebo
    Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.
  • 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
  • Placebo Comparator: 1
    Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial.
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
    Interventions:
    • Drug: levetiracetam
    • Drug: Levetriracetam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2008
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00413296
Pro00007843
7031-05-4R0 ( Other Identifier: DUMC )
Yes
Not Provided
Not Provided
Duke University
Duke University
UCB Pharma
Principal Investigator: Jonathan Davidson, M.D. Duke University
Duke University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP