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Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis - Article


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Sertraline

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Clinical Trial: Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

This study has been suspended.

Sponsors and Collaborators: National Institute of Child Health and Human Development (NICHD)
University of Florida
Information provided by: Office of Rare Diseases (ORD)

Purpose

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.

Condition Treatment or Intervention Phase
stereotyped behavior
Mental Retardation
 Drug: bromocriptine
 Drug: sertraline hydrochloride
Phase II

MedlinePlus related topics:  Developmental Disabilities

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  40

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

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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)

Location Information


North Carolina
      Western Carolina Center, Morganton,  North Carolina,  28655,  United States

Study chairs or principal investigators

Mark H. Lewis,  Study Chair,  University of Florida   

More Information

Study ID Numbers:  199/11754; UF-63394
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004300
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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