Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stereotyped Behavior; Mental Retardation
Intervention: bromocriptine (Drug); sertraline hydrochloride (Drug)
Phase: Phase 2
Status: Suspended
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Mark H. Lewis, Study Chair, Affiliation: University of Florida
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.
Clinical Details
Official title: Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Western Carolina Center, Morganton, North Carolina 28655, United States
Additional Information
Last updated: October 5, 2010
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