Repetitive Behavior Disorders in People With Severe Mental Retardation
Primary Purpose
Mental Retardation, Stereotyped Behavior, Self-Injurious Behavior
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
sertraline
Sponsored by
About this trial
This is an interventional treatment trial for Mental Retardation focused on measuring Repetitive behavior disorder, Stereotypy, Sertraline
Eligibility 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
Sites / Locations
- Department of PsychiatryRecruiting
- Western Carolina CenterRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00491478
First Posted
June 22, 2007
Last Updated
June 22, 2007
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00491478
Brief Title
Repetitive Behavior Disorders in People With Severe Mental Retardation
Official Title
Stereotypies and Mental Retardation: Neurobiological Basis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2003
Overall Recruitment Status
Unknown status
Study Start Date
September 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Retardation, Stereotyped Behavior, Self-Injurious Behavior, Compulsive Behavior
Keywords
Repetitive behavior disorder, Stereotypy, Sertraline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sertraline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Lewis, PhD
Phone
352-392-3471
Email
mlewis@psych.med.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Lewis, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0256
Country
United States
Individual Site Status
Recruiting
Facility Name
Western Carolina Center
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James W. Bodfish, PhD
Phone
828-483-6518
Email
Jim.Bodfish@westerncarolinacenter.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
8527113
Citation
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.
Results Reference
background
PubMed Identifier
8718995
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. No abstract available.
Results Reference
background
PubMed Identifier
11055459
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. doi: 10.1023/a:1005596502855.
Results Reference
background
PubMed Identifier
11321603
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. doi: 10.1352/0895-8017(2001)1062.0.CO;2.
Results Reference
background
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Repetitive Behavior Disorders in People With Severe Mental Retardation
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