Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

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Primary Purpose

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

bromocriptine

sertraline hydrochloride

About this trial

This is an interventional treatment trial for Stereotyped Behavior focused on measuring mental retardation, neurologic and psychiatric disorders, rare disease, stereotyped behavior

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of mental retardation High rate of stereotyped behavior, such as concomitant self-injurious and compulsive behaviors No diagnosis of tardive dyskinesia or akathisia --Prior/Concurrent Therapy-- No exposure to neuroleptics within 6 months prior to study --Patient Characteristics-- Age: 18 to 55 Hematopoietic: (for bromocriptine and sertraline treatments) No history of anemia No clinically significant hematologic disease Hepatic: (for bromocriptine and sertraline treatments) No history of hepatic abnormalities No clinically significant liver disease Renal: (for bromocriptine and sertraline treatments) No history of renal abnormalities No clinically significant renal disease Cardiovascular: (for bromocriptine and sertraline treatments) No history of hypertension No clinically significant cardiac disease Other: No history of seizure within 4 months prior to study (for bromocriptine and sertraline treatments) No history of sensitivity to ergot alkaloids (for bromocriptine treatment) No sensitivity to serotonin uptake inhibitors (for sertraline treatment) No patients with sensory deficits (for motor function assessments)

Sites / Locations

Western Carolina Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004300

First Posted

October 18, 1999

Last Updated

October 5, 2010

Sponsor

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

Collaborators

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT00004300

Brief Title

Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

Official Title

Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2006

Overall Recruitment Status

Suspended

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

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

Collaborators

University of Florida

4. Oversight

5. Study Description

Brief Summary

OBJECTIVES: I. Determine differences between persons with repetitive behavior disorders and matched controls on measures of motor control relevant to basal ganglia pathophysiology. II. Determine the efficacy of bromocriptine, a dopamine agonist, in the treatment of stereotyped behavior and related behavior disorders. III. Determine the efficacy of sertraline hydrochloride, a selective serotonin uptake inhibitor, in the treatment of repetitive behavior disorders. IV. Identify behavioral, environmental, and biological variables with differential drug treatment response.

Detailed Description

PROTOCOL OUTLINE: Motor slowness (bradykinesia) and motor control are tested in repetitive behavior disorder patients and matched controls. Group differences reflecting alterations in basal ganglia dopamine function are compared. Behavioral assessments are conducted on each patient by trained observers. Assessments are taken at baseline and during the maintenance phase of drug treatment described below. The efficacy of bromocriptine in the treatment of stereotypy and self-injury is determined in a randomized, double blind, placebo controlled, crossover study extending over 20 weeks. Cohorts of 6 to 8 patients first enter into a single blind placebo phase, followed by double blind treatment with placebo or bromocriptine. The crossover manipulation entails a titration phase, a maintenance phase, then a final single blind placebo condition. The same experimental design is used to determine the efficacy of sertraline or placebo in the treatment of stereotypy and concomitant self injury and compulsions. Duration of study is 26 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stereotyped Behavior, Mental Retardation

Keywords

mental retardation, neurologic and psychiatric disorders, rare disease, stereotyped behavior

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

bromocriptine

Intervention Type

Drug

Intervention Name(s)

sertraline hydrochloride

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of mental retardation High rate of stereotyped behavior, such as concomitant self-injurious and compulsive behaviors No diagnosis of tardive dyskinesia or akathisia --Prior/Concurrent Therapy-- No exposure to neuroleptics within 6 months prior to study --Patient Characteristics-- Age: 18 to 55 Hematopoietic: (for bromocriptine and sertraline treatments) No history of anemia No clinically significant hematologic disease Hepatic: (for bromocriptine and sertraline treatments) No history of hepatic abnormalities No clinically significant liver disease Renal: (for bromocriptine and sertraline treatments) No history of renal abnormalities No clinically significant renal disease Cardiovascular: (for bromocriptine and sertraline treatments) No history of hypertension No clinically significant cardiac disease Other: No history of seizure within 4 months prior to study (for bromocriptine and sertraline treatments) No history of sensitivity to ergot alkaloids (for bromocriptine treatment) No sensitivity to serotonin uptake inhibitors (for sertraline treatment) No patients with sensory deficits (for motor function assessments)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark H. Lewis

Organizational Affiliation

University of Florida

Official's Role

Study Chair

Facility Information:

Facility Name

Western Carolina Center

City

Morganton

State/Province

North Carolina

ZIP/Postal Code

28655

Country

United States

Stereotyped Behavior, Mental Retardation

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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