Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis
NCT ID: NCT00004300
Last Updated: 2010-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
40 participants
INTERVENTIONAL
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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bromocriptine
sertraline hydrochloride
Eligibility Criteria
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Inclusion 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)
18 Years
55 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Responsible Party
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University of Florida
Principal Investigators
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Mark H. Lewis
Role: STUDY_CHAIR
University of Florida
Locations
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Western Carolina Center
Morganton, North Carolina, United States
Countries
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Other Identifiers
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UF-63394
Identifier Type: -
Identifier Source: secondary_id
199/11754
Identifier Type: -
Identifier Source: org_study_id