Levetiracetam in Post-Traumatic Stress Disorder (PTSD)

This study has been completed.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00413296
First received: December 18, 2006
Last updated: July 18, 2014
Last verified: June 2010
  Purpose

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 Intervention Phase
Post-Traumatic Stress Disorder
Drug: levetiracetam
Drug: Placebo
Drug: Levetriracetam
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: 20 wks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Davidson Trauma Scale (DTS) [ Time Frame: 20 wks ] [ Designated as safety issue: Yes ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 20 wks ] [ Designated as safety issue: Yes ]
  • Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: 20 wks ] [ Designated as safety issue: Yes ]
  • 36-item Short Form Health Survey (SF-36) [ Time Frame: 20 wks ] [ Designated as safety issue: Yes ]
  • Pittsburgh Sleep Quality Index [ Time Frame: 20 wks ] [ Designated as safety issue: Yes ]
  • Work Productivity and Activity Improvement Questionnaire (WPAI) [ Time Frame: 20 wks ] [ Designated as safety issue: Yes ]
  • Sheehan Disability Inventory (SDI) [ Time Frame: 20 wks ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: November 2005
Study Completion Date: March 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Placebo
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413296

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00413296     History of Changes
Other Study ID Numbers: Pro00007843, 7031-05-4R0
Study First Received: December 18, 2006
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
PTSD
Anxiety
Pharmacotherapy
Levetiracetam
Relapse prevention

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014