Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborator: University of Florida
• Treatments: Bromocriptine; Sertraline

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)