Mental Retardation Clinical Trial
Official title:
Stereotypies and Mental Retardation: Neurobiological Basis
NCT number | NCT00491478 |
Other study ID # | R01HD030615 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | June 22, 2007 |
Last updated | June 22, 2007 |
Start date | September 1992 |
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.
Status | Recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Department of Psychiatry | Gainesville | Florida |
United States | Western Carolina Center | Morganton | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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
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