NCT00413296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 21, 2014

Status Verified

June 1, 2010

Enrollment Period

1.8 years

First QC Date

December 18, 2006

Last Update Submit

July 18, 2014

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSDAnxietyPharmacotherapyLevetiracetamRelapse prevention

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impressions - Improvement (CGI-I)

    20 wks

Secondary Outcomes (7)

  • Davidson Trauma Scale (DTS)

    20 wks

  • Hospital Anxiety and Depression Scale (HADS)

    20 wks

  • Connor-Davidson Resilience Scale (CD-RISC)

    20 wks

  • 36-item Short Form Health Survey (SF-36)

    20 wks

  • Pittsburgh Sleep Quality Index

    20 wks

  • +2 more secondary outcomes

Study Arms (2)

1

PLACEBO COMPARATOR

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

Drug: Placebo

2

ACTIVE COMPARATOR

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

Drug: levetiracetamDrug: Levetriracetam

Interventions

levetiracetamDRUG

Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks

Also known as: Keppra
2
PlaceboDRUG

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

1
LevetriracetamDRUG

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.

Also known as: Keppra
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety Disorders

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jonathan Davidson, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2006

First Posted

December 19, 2006

Study Start

November 1, 2005

Primary Completion

September 1, 2007

Study Completion

March 1, 2008

Last Updated

July 21, 2014

Record last verified: 2010-06

Locations

US(1)