A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
Collecte de données
Troubles Mentaux
+ Schizophrénie
+ Troubles du Spectre de la Schizophrénie et Autres Troubles Psychotiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 2004
Date à laquelle le premier participant a commencé l'étude.Key objectives of this clinical study are to: * Determine how well intramuscular (IM) olanzapine depot works compared to placebo * Evaluate the safety and tolerability of IM olanzapine depot compared to placebo * Evaluate different doses of IM olanzapine depot compared to placebo to identify the best dose(s).
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.402 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 75 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: * Patients must have schizophrenia and be experiencing a psychotic episode * Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent * Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry * Female patients must not be pregnant or breast-feeding * Female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia Exclusion Criteria: * Patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator * One or more seizures without a clear and resolved etiology is exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered. * Treatment with clozapine within 4 weeks prior to visit 1 * DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days * Treatment with remoxipride within 6 months (180 days) prior to visit 1
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
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 37 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician.
National City, United StatesVoir le siteFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician.
Orange, United StatesFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician.
Rosemead, United StatesFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician.
San Diego, United States