Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

Official Title: “Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis”

OBJECTIVES: I. Determine differences between persons with repetitive behavior disorders and matched controls on measures of motor control relevant to basal ganglia pathophysiology.

II. Determine the efficacy of bromocriptine, a dopamine agonist, in the treatment of stereotyped behavior and related behavior disorders.

III. Determine the efficacy of sertraline hydrochloride, a selective serotonin uptake inhibitor, in the treatment of repetitive behavior disorders.

IV. Identify behavioral, environmental, and biological variables with differential drug treatment response.

PROTOCOL OUTLINE: Motor slowness (bradykinesia) and motor control are tested in repetitive behavior disorder patients and matched controls. Group differences reflecting alterations in basal ganglia dopamine function are compared.

Behavioral assessments are conducted on each patient by trained observers. Assessments are taken at baseline and during the maintenance phase of drug treatment described below.

The efficacy of bromocriptine in the treatment of stereotypy and self-injury is determined in a randomized, double blind, placebo controlled, crossover study extending over 20 weeks.

Cohorts of 6 to 8 patients first enter into a single blind placebo phase, followed by double blind treatment with placebo or bromocriptine. The crossover manipulation entails a titration phase, a maintenance phase, then a final single blind placebo condition.

The same experimental design is used to determine the efficacy of sertraline or placebo in the treatment of stereotypy and concomitant self injury and compulsions. Duration of study is 26 weeks.

Intervention(s) in this Clinical Trial

• Drug: bromocriptine
• Drug: sertraline hydrochloride

PROTOCOL ENTRY CRITERIA:

• -Disease Characteristics--
• Diagnosis of mental retardation
• High rate of stereotyped behavior, such as concomitant self-injurious and compulsive behaviors
• No diagnosis of tardive dyskinesia or akathisia
• -Prior/Concurrent Therapy--
• No exposure to neuroleptics within 6 months prior to study
• -Patient Characteristics--
• Age: 18 to 55
• Hematopoietic: (for bromocriptine and sertraline treatments) No history of anemia No clinically significant hematologic disease
• Hepatic: (for bromocriptine and sertraline treatments) No history of hepatic abnormalities No clinically significant liver disease
• Renal: (for bromocriptine and sertraline treatments) No history of renal abnormalities No clinically significant renal disease
• Cardiovascular: (for bromocriptine and sertraline treatments) No history of hypertension No clinically significant cardiac disease
• Other: No history of seizure within 4 months prior to study (for bromocriptine and sertraline treatments) No history of sensitivity to ergot alkaloids (for bromocriptine treatment) No sensitivity to serotonin uptake inhibitors (for sertraline treatment) No patients with sensory deficits (for motor function assessments)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NIH

Overall Clinical Trial Officials and Contacts

Mark H. Lewis Study Chair University of Florida  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004300

Study ID Number: 199/11754

ClinicalTrials.gov Identifier: NCT00004300

Health Authority: United States: Federal Government