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| ID | Type | Description | Link |
|---|---|---|---|
| UF-63394 |
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| Name | Class |
|---|---|
| University of Florida | OTHER |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bromocriptine | Drug | |||
| sertraline hydrochloride | Drug |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
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| Name | Affiliation | Role |
|---|---|---|
| Mark H. Lewis | University of Florida | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Carolina Center | Morganton | North Carolina | 28655 | United States |
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| ID | Term |
|---|---|
| D013239 | Stereotyped Behavior |
| D008607 | Intellectual Disability |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001971 | Bromocriptine |
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D004879 | Ergotamines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D004873 |
| Ergolines |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |