Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

Duke University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Placebo; Drug: Levetiracetam; Drug: Sertraline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00299611

Pro00008596

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Levetiracetam

Treatment:

Drug: Sertraline

Drug: Levetiracetam

2

Placebo Comparator group

Description:

there is no active ingredient in the pills.

Treatment:

Drug: Placebo