Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

NCT00004300 | Suspended Phase 2

• 2 other identifiers: 199/11754UF-63394
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stereotyped Behavior; Mental Retardation

Keywords

mental retardation; neurologic and psychiatric disorders; rare disease; stereotyped behavior

Interventions

bromocriptine DRUG

sertraline hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• University of Florida: collaborator

Study Sites (1)

Western Carolina Center

Morganton, North Carolina, 28655, United States

Location

MeSH Terms

Conditions

Stereotyped Behavior; Intellectual Disability; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Bromocriptine; Sertraline

Condition Hierarchy (Ancestors)

Behavior; Neurobehavioral Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Mark H. Lewis

  University of Florida

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Last Updated: October 6, 2010

Record last verified: 2006-03

Locations

US (1)