Phase 4
N=17
Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder
Body Dysmorphic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00265109 ↗Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Nov 2010
Primary outcome: Primary: Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levetiracetam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Butler Hospital
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) |
9 | — |
| SECONDARY Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms |
8 | — |
| SECONDARY Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement. |
9 | — |
| SECONDARY Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms |
8 | — |
| SECONDARY Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement. |
8 | — |
| SECONDARY Scores on Brown Assessment of Beliefs Scale |
14.6; 10.4 | — |
| SECONDARY Scores on Clinical Global Severity |
5.2; 4.2 | — |
| SECONDARY Scores on Hamilton Depression Rating Scale |
18.1; 11.4 | — |
| SECONDARY Scores on Beck Anxiety Inventory |
12.4; 9.6 | — |
| SECONDARY Scores on Social Phobia Inventory |
32.9; 29.4 | — |
| SECONDARY Scores on Global Assessment of Functioning |
46.1; 55.8 | — |
| SECONDARY Scores on Social and Occupational Functioning Scale (SOFAS) |
47.0; 59.8 | — |
| SECONDARY Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form |
49.5; 57.4 | — |
Summary
The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with body dysmorphic disorder.
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.
Data sourced from ClinicalTrials.gov (NCT00265109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.