Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

Mental Retardation Clinical Trial

Official title:

Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00004300
• Other study ID #: 199/11754
• Secondary ID: UF-63394
• Status: Suspended
• Phase: Phase 2
• First received: October 18, 1999
• Last updated: October 5, 2010

Study information

• Verified date: March 2006
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intellectual Disability
• Mental Retardation
• Stereotyped Behavior

Intervention

Drug:
• bromocriptine

• sertraline hydrochloride

Locations

Country	Name	City	State
United States	Western Carolina Center	Morganton	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	University of Florida

Country where clinical trial is conducted

United States,