Repetitive Behavior Disorders in People With Severe Mental Retardation
NCT ID: NCT00491478
Last Updated: 2007-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
1992-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
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sertraline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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Mark Lewis, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Department of Psychiatry
Gainesville, Florida, United States
Western Carolina Center
Morganton, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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James W. Bodfish, PhD
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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