Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis
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.
Drug: sertraline hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis|
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.
|United States, North Carolina|
|Western Carolina Center|
|Morganton, North Carolina, United States, 28655|
|Study Chair:||Mark H. Lewis||University of Florida|