Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
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Purpose
The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with body dysmorphic disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Body Dysmorphic Disorder |
Drug: Levetiracetam |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label Study of Levetiracetam in Body Dysmorphic Disorder |
- Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) [ Time Frame: Baseline to end week 12 ] [ Designated as safety issue: No ]The BDD-YBOCS, a reliable and valid 12-item semi-structured clinician-administered scale assessed BDD severity during the past week. 38 items are rated from 0 (no symptoms) to 4 (extreme symptoms); range=0-48. This scale assesses preoccupation with the perceived appearance defects, associated compulsive behaviors, insight, and avoidance. A ≥30% decrease in total score indicated response.
- Body Dysmorphic Disorder Clinical Global Impressions Scale; Hamilton Rating Scale for Depression; Quality of Life Enjoyment and Satisfaction Questionnaire; Social Phobia Inventory; Beck Anxiety Inventory; [ Time Frame: Past week ] [ Designated as safety issue: Yes ]
| Enrollment: | 17 |
| Study Start Date: | December 2004 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
-
Drug: Levetiracetam
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Rhode Island | |
| Rhode Island Hospital Body Dysmorphic Disorder Program | |
| Providence, Rhode Island, United States, 02903 | |
| Principal Investigator: | Katharine A Phillips, M.D. | Rhode Island Hospital/ Brown University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Katharine Phillips, MD, Rhode Island Hospital |
| ClinicalTrials.gov Identifier: | NCT00265109 History of Changes |
| Other Study ID Numbers: | 0410-001 |
| Study First Received: | December 12, 2005 |
| Results First Received: | October 18, 2010 |
| Last Updated: | November 16, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Butler Hospital:
|
body dysmorphic disorder levetiracetam |
Additional relevant MeSH terms:
|
Body Dysmorphic Disorders Somatoform Disorders Mental Disorders Etiracetam Piracetam Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013