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Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004300
First Posted: October 19, 1999
Last Update Posted: October 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
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 Intervention Phase
Stereotyped Behavior Mental Retardation Drug: bromocriptine Drug: sertraline hydrochloride Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 40
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004300


Locations
United States, North Carolina
Western Carolina Center
Morganton, North Carolina, United States, 28655
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Florida
Investigators
Study Chair: Mark H. Lewis University of Florida
  More Information

Responsible Party: Mark Lewis, University of Florida
ClinicalTrials.gov Identifier: NCT00004300     History of Changes
Other Study ID Numbers: 199/11754
UF-63394
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: October 6, 2010
Last Verified: March 2006

Keywords provided by Office of Rare Diseases (ORD):
mental retardation
neurologic and psychiatric disorders
rare disease
stereotyped behavior

Additional relevant MeSH terms:
Intellectual Disability
Stereotypic Movement Disorder
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Sertraline
Bromocriptine
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Dopamine Agonists
Dopamine Agents