1. Efficacy
and Safety Study of Low-Dose Ondansetron (Serotonin-3 Receptor Antagonist) For
Adjunctive Therapy In Adult Patients With Obsessive-Compulsive Disorder
Patients
with Obsessive-Compulsive Disorder (OCD) can suffer from a broad range of functional
and health-related quality of life domains. Chronic OCD can interfere with
social and professional responsibilities, preventing patients from seeking
medical care or even connective with family. Serotonin reuptake inhibitors
(SRIs), drugs often prescribed for the treatment of OCD, do not work for about
40% of patients.
The drug
Ondansetron (brand name: Zofran) is usually prescribed to ameliorate nausea and
vomiting during chemotherapy. However, it is also reported to believed to act
on dopamine pathways that could, combined with an SRI, be used as treatment for
patients with OCD. This study aims to assess the efficacy and safety of low
doses of Ondansetron (.5mg and .75mg) in conjunction with regimented SRI
treatments. Combined at the correct doses, Ondansetron and an existing SRI may
provide much needed treatment for patients with OCD.
If you or your child are interested in participating in this study,
please contact Tara Kahn at (718) 653-4859 x226 or tkahn@montefiore.org
2. Fluoxetine
in Pediatric Body Dysmorphic Disorder
**note: this study has completed**
Body dysmorphic
disorder (BDD)--a preoccupation with an imagined or slight defect in
appearance--is a distressing and impairing disorder that usually begins during
childhood or adolescence. With a chronic course, associated rates of social and
academic impairment, and considerable cause of morbidity, adolescent BDD
requires more clinical attention than it is currently given. The broad
objective of this study is to increase knowledge about BDD, an understudied
disorder in children and adolescents, by investigating its response to an SRI
in a controlled fashion in this age group. Our specific research questions are:
1. assess the efficacy and safety of fluoxetine vs.
placebo in BDD and its delusional disorder variant
2. explore whether delusionality (insight), the
presence of comorbid major depression or obsessive compulsive disorder (OCD),
and/or illness severity predicts response to fluoxetine.
Importance
This study will
provide much needed data for a population in great need of a reliable clinical
treatment; pediatric BDD has received virtually no investigation and the
symptoms of BDD can be debilitating, leading to psychiatric hospitalization and
suicide attempts. Pediatric-onset BDD appears to interfere with the
developmental tasks of childhood and adolescence, and pediatric BDD has a more
malignant course of illness than adult-onset BDD.
If you or your child are interested in participating in this study,
please contact Tara Kahn at (718) 653-4859 x226 or tkahn@montefiore.org