Repetitive Behavior Disorders in People With Severe Mental Retardation
Status unconfirmed · Phase 3
Conditions studied: Mental Retardation, Stereotyped Behavior, Self-Injurious Behavior, Compulsive Behavior
In brief
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.
Key facts
- Study ID
- NCT00491478
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Starts
- 1992-09-01
- Last updated by the study team
- 2007-06-26
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Department of Psychiatry — Gainesville, Florida, United States (enrolling)
- Western Carolina Center — Morganton, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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