Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Stereotyped Behavior Mental Retardation	Drug: bromocriptine Drug: sertraline hydrochloride	Phase II

Drug Information available for:

Bromocriptine Bromocriptine mesylate Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:

40

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004300

Locations


United States, North Carolina
	Western Carolina Center
	Morganton, North Carolina, United States, 28655

Sponsors and Collaborators

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

University of Florida

Investigators


Study Chair:	Mark H. Lewis	University of Florida

More Information

Study ID Numbers:	199/11754, UF-63394
First Received:	October 18, 1999
Last Updated:	March 21, 2006
ClinicalTrials.gov Identifier:	NCT00004300
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

mental retardation

neurologic and psychiatric disorders

rare disease

stereotyped behavior

Study placed in the following topic categories:

Mental Retardation

Bromocriptine

Signs and Symptoms

Dopamine

Mental Disorders

Mental Disorders Diagnosed in Childhood

Rare Diseases

Sertraline

Neurologic Manifestations

Neurobehavioral Manifestations

Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Hormone Antagonists

Nervous System Diseases

Physiological Effects of Drugs

Psychotropic Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiparkinson Agents

Dopamine Agonists

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) University of Florida
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004300