Full Text View
Tabular View
No Study Results Posted
Related Studies
Repetitive Behavior Disorders in People With Severe Mental Retardation
This study is currently recruiting participants.
Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), May 2003
First Received: June 22, 2007   No Changes Posted
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00491478
  Purpose

Repetitive behavior disorders are prevalent among people with severe mental retardation. These disorders can interfere significantly with an individual’s daily functions. This trial is part of a long-term project that has studied the biologic basis of and possible treatments for repetitive behavior disorders. The trial will evaluate the effectiveness of two medications, a selective serotonin reuptake inhibitor (SSRI) and an atypical antipsychotic, in treating repetitive behavior disorders in people with mental retardation.


Condition Intervention Phase
Mental Retardation
Stereotyped Behavior
Self-Injurious Behavior
Compulsive Behavior
Drug: sertraline
Phase III

Drug Information available for: Sertraline hydrochloride Sertraline
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title: Stereotypies and Mental Retardation: Neurobiological Basis

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Study Start Date: September 1992
Detailed Description:

Abnormal repetitive behaviors (odd or inappropriate movements, self-injury, and compulsions) are among the aberrant behaviors exhibited by individuals with mental retardation. However, little is known about their pathobiology and treatments are largely unconfirmed by controlled trials. For example, few controlled studies have examined the efficacy of pharmacological treatment of abnormal repetitive behavior in individuals with mental retardation.

This trial is part of a larger project designed to elucidate the neurobiological bases of repetitive behavior disorders and to develop rational, safe, and effective pharmacological treatments. Thus far, the project has established a pathophysiological basis for stereotyped behavior disorder, demonstrated the role of central dopamine deficiency in stereotyped behavior disorder, and provided evidence of the efficacy of both 5-HT uptake inhibitors and atypical antipsychotics in treating stereotyped behaviors.

There is currently little information to guide the clinician in deciding which drug class may be more effective for which abnormal repetitive behaviors and for which individuals. Moreover, little work has attempted to identify variables that may predict differential treatment response. This trial will assess the relative efficacy of an SSRI and an atypical antipsychotic across multiple categories of abnormal repetitive behaviors.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Mental retardation
  • Medically stable resident of either Western Carolina Center, Morganton, NC or Tacachale Community, Gainesville, FL
  • Free of sensory deficits
  • Ambulatory
  • High rate of stereotyped behavior that may co-occur with self-injurious or compulsive behaviors

Exclusion Criteria

  • Poor general health
  • Cardiac, hepatic, or renal abnormalities
  • Seizure within 4 months prior to study entry (patients on seizure medication who have not had a seizure within 4 months prior to study entry may participate)
  • Tardive dyskinesia
  • Akathisia
  • Neuroleptic use within 6 months of study entry
  • History of sensitivity to ergot alkaloids
  • Hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491478

Contacts
Contact: Mark Lewis, PhD 352-392-3471 mlewis@psych.med.ufl.edu

Locations
United States, Florida
Department of Psychiatry Recruiting
Gainesville, Florida, United States, 32610-0256
United States, North Carolina
Western Carolina Center Recruiting
Morganton, North Carolina, United States, 28655
Contact: James W. Bodfish, PhD     828-483-6518     Jim.Bodfish@westerncarolinacenter.org    
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Lewis, PhD University of Florida
  More Information

Publications:
Study ID Numbers: R01HD30615
Study First Received: June 22, 2007
Last Updated: June 22, 2007
ClinicalTrials.gov Identifier: NCT00491478     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Repetitive behavior disorder
Stereotypy
Sertraline

Study placed in the following topic categories:
Neurotransmitter Agents
Psychotropic Drugs
Impulsive Behavior
Serotonin Uptake Inhibitors
Serotonin
Behavioral Symptoms
Mental Retardation
Compulsive Behavior
Signs and Symptoms
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Sertraline
Neurobehavioral Manifestations
Antidepressive Agents
Self-Injurious Behavior

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Impulsive Behavior
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Mental Retardation
Compulsive Behavior
Signs and Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Sertraline
Central Nervous System Agents
Neurobehavioral Manifestations
Antidepressive Agents
Self-Injurious Behavior

ClinicalTrials.gov processed this record on May 07, 2009