Recruiting
Phase 3

SSRI & Atypical Antipsychotic

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00491478

Conditions

Mental Retardation

Stereotyped Behavior

Self-Injurious Behavior

Compulsive Behavior

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

sertraline

Study Details

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.

Conditions

Mental Retardation

Stereotyped Behavior

Self-Injurious Behavior

Compulsive Behavior

Study ID

NCT00491478

Start date

Sep, 1992

Status verified date

May, 2003

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

sertraline

Central Contacts and Locations

Central contacts

Mark Lewis, PhD

352-392-3471mlewis@psych.med.ufl.edu

Locations

Department of Psychiatry

Recruiting

Gainesville, Florida, United States, 32610-0256

Western Carolina Center

Recruiting

Morganton, North Carolina, United States, 28655

Contacts

James W. Bodfish, PhD

828-483-6518Jim.Bodfish@westerncarolinacenter.org

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Jun 26, 2007

Last verified

May, 2003

Keywords

  • Repetitive behavior disorder
  • Stereotypy
  • Sertraline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2007-06-26.