Repetitive Behavior Disorders in People With Severe Mental Retardation

Mental Retardation Clinical Trial

Official title:

Stereotypies and Mental Retardation: Neurobiological Basis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00491478
• Other study ID #: R01HD030615
• Status: Recruiting
• Phase: Phase 3
• First received: June 22, 2007
• Last updated: June 22, 2007
• Start date: September 1992

Study information

• Verified date: May 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: Mark Lewis, PhD
• Phone: 352-392-3471
• Email: mlewis[@]psych.med.ufl.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Intellectual Disability
• Mental Retardation
• Obsessive-Compulsive Disorder
• Self-Injurious Behavior
• Stereotyped Behavior

Intervention

Drug:
• sertraline

Locations

Country	Name	City	State
United States	Department of Psychiatry	Gainesville	Florida
United States	Western Carolina Center	Morganton	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bodfish JW, Crawford TW, Powell SB, Parker DE, Golden RN, Lewis MH. Compulsions in adults with mental retardation: prevalence, phenomenology, and comorbidity with stereotypy and self-injury. Am J Ment Retard. 1995 Sep;100(2):183-92. — View Citation

Bodfish JW, Parker DE, Lewis MH, Sprague RL, Newell KM. Stereotypy and motor control: differences in the postural stability dynamics of persons with stereotyped and dyskinetic movement disorders. Am J Ment Retard. 2001 Mar;106(2):123-34. — View Citation

Bodfish JW, Symons FJ, Parker DE, Lewis MH. Varieties of repetitive behavior in autism: comparisons to mental retardation. J Autism Dev Disord. 2000 Jun;30(3):237-43. — View Citation

Lewis MH, Bodfish JW, Powell SB, Wiest K, Darling M, Golden RN. Plasma HVA in adults with mental retardation and stereotyped behavior: biochemical evidence for a dopamine deficiency model. Am J Ment Retard. 1996 Jan;100(4):413-8. — View Citation