Trial intelligence / Profile preview

Levetiracetam in Body Dysmorphic Disorder

NCT00265109Phase 4

Key facts

Status: Completed
Start: Dec 2004
Primary completion: Jan 2008
Countries: 1
Sponsor: Butler Hospital
Modality: Small Molecules

Drugs: levetiracetam
Conditions: body dysmorphic disorder (BDD)

Overview

Phase 4, open-label, single-arm trial of levetiracetam in body dysmorphic disorder (BDD), sponsored by Butler Hospital. Primary endpoint: Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder at 12 weeks. Started Dec 2004; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

open label
All participants received levetiracetam

Endpoints

Primary

Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder12 weeks

Secondary

Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms12 weeks
Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement12 weeks
Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms12 weeks
Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement12 weeks
Brown Assessment of Beliefs Scale12 weeks
Clinical Global Severity12 weeks
Hamilton Depression Rating Scale12 weeks
Beck Anxiety Inventory12 weeks

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