NCT00491478

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1992

Completed
14.8 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
Last Updated

June 26, 2007

Status Verified

May 1, 2003

First QC Date

June 22, 2007

Last Update Submit

June 22, 2007

Conditions

Keywords

Repetitive behavior disorderStereotypySertraline

Interventions

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Psychiatry

Gainesville, Florida, 32610-0256, United States

RECRUITING

Western Carolina Center

Morganton, North Carolina, 28655, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 8527113BACKGROUND
  • 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.

    PMID: 8718995BACKGROUND
  • 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.

    PMID: 11055459BACKGROUND
  • 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.

    PMID: 11321603BACKGROUND

MeSH Terms

Conditions

Intellectual DisabilityStereotyped BehaviorSelf-Injurious BehaviorCompulsive BehaviorStereotypic Movement Disorder

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBehaviorBehavioral SymptomsImpulsive Behavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Mark Lewis, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 22, 2007

First Posted

June 26, 2007

Study Start

September 1, 1992

Last Updated

June 26, 2007

Record last verified: 2003-05

Locations