Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis
bromocriptine
+ sertraline hydrochloride
Maladies du système nerveux+8
+ Processus pathologiques
+ Signes et symptômes
Étude thérapeutique
Résumé
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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.40 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 55 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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)
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site