Repetitive Behavior Disorders in People With Severe Mental Retardation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00491478
First received: June 22, 2007
Last updated: NA
Last verified: May 2003
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Stereotypies and Mental Retardation: Neurobiological Basis

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00491478     History of Changes
Other Study ID Numbers: R01HD30615
Study First Received: June 22, 2007
Last Updated: June 22, 2007
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

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

ClinicalTrials.gov processed this record on August 19, 2014