Levetiracetam in Post-Traumatic Stress Disorder - Full Text View

Sponsors and Collaborators:	Duke University UCB
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00413296

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 II Phase III

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder

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
1: Placebo Comparator 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.
2: Active Comparator 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 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.

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

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

Investigators

Principal Investigator:

Jonathan Davidson, M.D.

Duke University

More Information

Responsible Party:	Duke university Medical Center ( Dr. Wei Zhang )
Study ID Numbers:	7031-05-4R0
Study First Received:	December 18, 2006
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00413296
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

PTSD
Anxiety
Pharmacotherapy
Levetiracetam
Relapse prevention

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Piracetam
Stress Disorders, Post-Traumatic

Stress
Etiracetam
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Nootropic Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009