Clinical trial NCT00265109: Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
Official title: Open-Label Study of Levetiracetam in Body Dysmorphic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Body Dysmorphic Disorder
Keywords: body dysmorphic disorder
levetiracetam
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2005-12-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with body dysmorphic disorder.

Detailed description: Body dysmorphic disorder (BDD), a perceived defect in appearance (e.g., a "large" nose or facial "scarring"), is a relatively common disorder that causes marked distress and impairment in functioning. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs); however, response to SRIs is often only partial. About one third of patients do not respond to an SRI. Furthermore, patients may stop taking SRIs because of side effects (e.g., sexual side effects). For these reasons, additional monotherapy and SRI augmentation strategies are greatly needed.

Levetiracetam is primarily used as an antiseizure medication and has a wider safety margin than other antiepileptics. Preliminary scientific studies may suggest that it may be helpful for certain psychiatric symptoms and disorders. In the present study we propose to obtain pilot data on 1) levetiracetam monotherapy and 2) levetiracetam augmentation of SRIs in patients with BDD.

Eligibility criteria: Inclusion Criteria:

* Men and women age 18-65;
* Current DSM-IV BDD or its delusional variant (delusional disorder, somatic type) for at least 3 months;
* A minimum total score of 20 on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) (19);
* Suitable for treatment in an outpatient setting

Exclusion Criteria:

* Unstable medical illness, including renal failure or dialysis;
* Myocardial infarction within 6 months;
* Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
* A need for prn benzodiazepines, another antiepileptic medication, or an anticipated change in the dose of any concomitant medications while receiving treatment with levetiracetam;
* Clinically significant suicidality, including a suicide attempt within the past two months;
* Lifetime history of DSM-IV dementia, schizophrenia, or any other DSM-IV psychotic disorder that is not attributable to BDD;
* Current or recent (past 3 months) DSM-IV substance abuse or dependence;
* Initiation of ongoing psychotherapy from a mental health professional within 3 months prior to study baseline;
* Ongoing cognitive-behavioral therapy from a mental health professional;
* Previous treatment with levetiracetam;
* Treatment with investigational medication, depot neuroleptics, or ECT within the past 3 months.

Primary outcomes:
measure: Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
timeFrame: Baseline to end week 12
Secondary outcomes:
measure: Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms
timeFrame: Last week of treatment (week 12) or last week of treatment for early dropouts
measure: Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.
timeFrame: Last week of treatment (week 12)
measure: Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms
timeFrame: Last week of treatment (week 12) or last week of treatment for early dropouts
measure: Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.
timeFrame: Last week of treatment (week 12)
measure: Scores on Brown Assessment of Beliefs Scale
timeFrame: Pre- and post-treatment (week 12)
measure: Scores on Clinical Global Severity
timeFrame: Pre- and post-treatment (week 12)
measure: Scores on Hamilton Depression Rating Scale
timeFrame: Pre- and post-treatment (week 12)
measure: Scores on Beck Anxiety Inventory
timeFrame: Pre- and post-treatment (week 12)
measure: Scores on Social Phobia Inventory
timeFrame: Pre- and post-treatment (week 12)
measure: Scores on Global Assessment of Functioning
timeFrame: Pre- and post-treatment (week 12)
measure: Scores on Social and Occupational Functioning Scale (SOFAS)
timeFrame: Pre- and post-treatment (week 12)
measure: Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form
timeFrame: Pre- and post-treatment (week 12)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital Body Dysmorphic Disorder Program
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital/ Brown University
name: Katharine A Phillips, M.D.
role: PRINCIPAL_INVESTIGATOR
References: