Research on the Effectiveness of Risperidone in Bipolar Disorder in Adolescents and Children (REACH): A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Risperidone for the Treatment of Acute Mania in Bipolar I Disorder
Collecte de données
Troubles bipolaires et apparentés+1
+ Troubles Mentaux
+ Trouble bipolaire
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 2003
Date à laquelle le premier participant a commencé l'étude.Subjects will be aged 10 to 17 years with a diagnosis of Bipolar I disorder and suffering from a current mixed or manic episode. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 0.5 to 2.5 mg, or oral risperidone tablets 3 to 6 mg), which will be administered daily for 3 weeks. Study medication will be increased to the target dosage during the first 7 days, then further increased within the target dosage range reached until maximum tolerated dose is reached by day 10. The maximum tolerated dose will be given for the last 12 days of the study. Risperidone (0.5 to 2.5 mg or 3 to 6 mg doses) or placebo given orally as 0.25, 0.5, 1, 2, 3, or 4 mg tablets (or matching placebo) each day for 3 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.13 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 10 à 17 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Current primary diagnosis of bipolar I disorder, mania or mixed type * Aged between 10 and 17 years * Young Mania Rating Scale score greater than or equal to 20 at screening and baseline Exclusion Criteria: * Known or suspected history of substance dependence * Significant risk for suicidal or violent behavior * Received electroconvulsive treatment within 4 weeks of baseline * Received a depot antipsychotic within 2 treatment cycle before baseline * Is unable to swallow medication taken in the form of tablets * Has a positive result for a urine drug screen done at baseline * Known or suspected seizure disorder * Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening * Known or suspected history of hypersensitivity or intolerance to risperidone * History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires