Repetitive Behavior Disorders in People With Severe Mental Retardation

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Sertraline

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