Augmentation Study of Levetiracetam in Obsessive Compulsi... | NCT00299611

Studies
Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

NCT00299611

Sponsor

Duke University

Status

Terminated

Last Update Posted

Apr 11, 2013Estimated

Enrollment

12Actual

Phase

Phase 2Phase 3

Conditions

Obsessive-Compulsive Disorder

Interventions

Sertraline
Levetiracetam
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decided to terminate the study due to budget consideration

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Apr 2008Actual

First Submitted Date

Mar 6, 2006

First Submission Date that Met QC Criteria

Mar 6, 2006

First Posted Date

Mar 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2013

Last Update Posted Date

Apr 11, 2013Estimated

Name	Class
UCB Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This is an investigator-initiated, single-site study, consisting of two phases: 8 weeks of open-label treatment with sertraline (50mg-150mg/day) in patients iwth OCD.At week 8, those who have failed to achieve remission will be continued on sertraline and will be randomized to receive Levetiracetam (500mg-2000mg/day) or Placebo for 8 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Levetiracetam	Drug: Sertraline Drug: Levetiracetam
2	Placebo Comparator	there is no active ingredient in the pills.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sertraline	Drug	Tablets, 50mg each, (1-3TABLETS/DAY) during the Open-label phase for first 8 wks.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Global Impression-improvement (CGI-I)		24 wks

Secondary Outcomes

Measure	Description	Time Frame
Yale-Brown Obsessive-Compulsive Scale (YBOCS)		24 wks
Hospital Anxiety and Depression Scale		24 wks
Sheehan Disability Scale (SDS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei Zhang, MD, PhD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27710	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9758307	Background	Ellingrod VL. Pharmacotherapy of primary obsessive-compulsive disorder: review of the literature. Pharmacotherapy. 1998 Sep-Oct;18(5):936-60.
9393390	Background	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.

ID	Term
D015057	1-Naphthylamine
D000588	Amines
D009930	Organic Chemicals
D009281	Naphthalenes

ID	Term
D009771	Obsessive-Compulsive Disorder
D001008	Anxiety Disorders