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Levetiracetam in Post-Traumatic Stress Disorder (PTSD)

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
levetiracetam
Placebo
Levetriracetam
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Anxiety, Pharmacotherapy, Levetiracetam, Relapse prevention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.

Outcomes

Primary Outcome Measures

Clinical Global Impressions - Improvement (CGI-I)

Secondary Outcome Measures

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 Productivity and Activity Improvement Questionnaire (WPAI)
Sheehan Disability Inventory (SDI)

Full Information

First Posted
December 18, 2006
Last Updated
July 18, 2014
Sponsor
Duke University
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00413296
Brief Title
Levetiracetam in Post-Traumatic Stress Disorder
Acronym
PTSD
Official Title
A Double-Blind Discontinuation Study of Levetiracetam in Post- Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
UCB Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Anxiety, Pharmacotherapy, Levetiracetam, Relapse prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Tablets, no active ingredient, 1-6 tablets/day for 12 wks in the 2 nd phase of the trial.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Levetiracetam, 500mg (1-6 tablets /day) for 12 wks in the 2nd phase of the study.
Intervention Type
Drug
Intervention Name(s)
levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.
Intervention Type
Drug
Intervention Name(s)
Levetriracetam
Other Intervention Name(s)
Keppra
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Global Impressions - Improvement (CGI-I)
Time Frame
20 wks
Secondary Outcome Measure Information:
Title
Davidson Trauma Scale (DTS)
Time Frame
20 wks
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
20 wks
Title
Connor-Davidson Resilience Scale (CD-RISC)
Time Frame
20 wks
Title
36-item Short Form Health Survey (SF-36)
Time Frame
20 wks
Title
Pittsburgh Sleep Quality Index
Time Frame
20 wks
Title
Work Productivity and Activity Improvement Questionnaire (WPAI)
Time Frame
20 wks
Title
Sheehan Disability Inventory (SDI)
Time Frame
20 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Davidson, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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Levetiracetam in Post-Traumatic Stress Disorder

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