NCT00299611

Brief Summary

The purpose of this study is to evaluate the effectiveness of Levetiracetam augmentation relative to Placebo in SSRI non-remitters with obsessive compulsive disorder. The hypothesis is that anxiolytic effect of Levetiracetam is more beneficial when adding with a SSRI.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
terminated

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
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 11, 2013

Status Verified

June 1, 2010

Enrollment Period

2.1 years

First QC Date

March 6, 2006

Last Update Submit

April 9, 2013

Conditions

Obsessive-Compulsive Disorder

Keywords

OCDAnxietyPharmacotherapySertralineLevetiracetam

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression-improvement (CGI-I)

    24 wks

Secondary Outcomes (3)

  • Yale-Brown Obsessive-Compulsive Scale (YBOCS)

    24 wks

  • Hospital Anxiety and Depression Scale

    24 wks

  • Sheehan Disability Scale (SDS)

    24 wks

Study Arms (2)

1

ACTIVE COMPARATOR

Levetiracetam

Drug: SertralineDrug: Levetiracetam

2

PLACEBO COMPARATOR

there is no active ingredient in the pills.

Drug: Placebo

Interventions

SertralineDRUG

Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.

Also known as: Zoloft
1
LevetiracetamDRUG

Tablets, dosage 500mg each tablet (1-4tablets/day)for 8 wks during the 2nd phase of the study.

Also known as: Keppra
1
PlaceboDRUG

Tablets, No active ingredient, (1-4tablets/day) for 8 wks during the 2nd phase of the study.

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 OCD based on DSM-IV criteria and assessed by the MINI International Neuropsychiatric Interview
  • Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of at least 16 or greater on screening
  • Ability to provide written consent form

You may not qualify if:

  • Any primary DSM-IV Axis I disorder other than OCD
  • Substance abuse during the last 6 months
  • A clinically unstable medical condition or clinically significant laboratory abnormalities
  • Suicidal risk or serious suicidal attept during the last year
  • Concurrent use of psychotropic medication including benzodiazepines, barbituates, 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 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, 27710, United States

Location

Related Publications (3)

  • Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998 Sep-Oct;18(5):936-60.

    PMID: 9758307BACKGROUND

  • Sasson Y, Zohar J, Chopra M, Lustig M, Iancu I, Hendler T. Epidemiology of obsessive-compulsive disorder: a world view. J Clin Psychiatry. 1997;58 Suppl 12:7-10.

    PMID: 9393390BACKGROUND

  • Steketee G. Disability and family burden in obsessive-compulsive disorder. Can J Psychiatry. 1997 Nov;42(9):919-28. doi: 10.1177/070674379704200902.

    PMID: 9429061BACKGROUND

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive DisorderAnxiety Disorders

Interventions

SertralineLevetiracetam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAcetamidesAmidesAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wei Zhang, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2006

First Posted

March 7, 2006

Study Start

November 1, 2005

Primary Completion

December 1, 2007

Study Completion

April 1, 2008

Last Updated

April 11, 2013

Record last verified: 2010-06

Locations

US(1)