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- Registre américain des essais cliniques
- Essai clinique NCT00222495
A Comparative Study of New Medications for Psychosis in Adolescents
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The purpose of this study is to compare the efficacy and tolerance of three atypical antipsychotics, which are medications that have been in use for about the last 10 years, in the treatment of psychosis in adolescents. Efficacy refers to how well the medications work in decreasing symptoms associated with schizophrenia, and tolerance refers to the level of side effects and the compliance with taking the medications. All three medications have demonstrated efficacy in treating psychosis without causing extra pyramidal side effects (uncontrolled muscle movements) that are associated with typical, or older antipsychotic medications. Young people may be at a greater risk for side effects from the typical antipsychotic medications. There are studies of the efficacy and tolerance among patients under 18-years-old taking the three drugs in this study: risperidone, olanzapine, and quetiapine. However, at this time there is little data available comparing these three medications. This study is an open-label, random assignment, 12-week study to assess the efficacy and tolerance of these three atypical antipsychotic medications in the treatment of adolescents (ages 12-18) with schizophrenia or psychosis. The participants will be informed of which medication she/he is taking, and will be assigned to the medication randomly (based on chance rather than choice).
There are additional theoretical beliefs in regard to this study as well. A secondary hypothesis of this study is that quetiapine will have less extra pyramidal side effects (EPS) and less prolactin-related side effects than risperidone. A third hypothesis is that quetiapine will lead to less weight gain than olanzapine and risperidone. Finally, it is hypothesized that because of the fewer side effects, quetiapine will be better tolerated than risperidone and olanzapine.
Type d'étude
Inscription
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55454
- University of Minnesota Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Subjects are between the ages of 12-18 and have a diagnosis of a psychotic illness.
- Subject currently meets criteria for one of the following disorders: schizophrenia, schizoaffective disorder (mainly schizophrenic), schizophreniform disorder, and psychosis NOS.
- Subject is in good physical health and not suffering from any medical disorder that might mimic psychosis or lead to medical difficulty with the study medications.
- If subject is taking antipsychotic medication before study entry, their medicine will be discontinued for 1-4 days depending on symptoms.
Exclusion Criteria:
- Subject has a medical disorders that would interfere with the study, such as epilepsy, thyroid disease, liver disease, AIDS, etc.
- Subject currently has substance dependence.
- Subject is talking a medication that inhibits or induces the cytochrome P450 3A4 (specific medications listed in Appendix of protocol).
3. Subject meets criteria for brief psychosis or mood disorder with psychotic features.
4. Female subject is pregnant or nursing.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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SCI-PANSS = Structured Clinical Interview - Positive and Negative Syndrome Scale
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CGI = Clinical Global Impressions
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GAF = Global Assessment of Functioning Scale
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Mesures de résultats secondaires
Mesure des résultats |
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Neuropsychological assessment battery
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Calgary Depression Symptoms for Schizophrenia
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AIMS = Abnormal Involuntary Movement Scale
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Barnes-Akathisia Rating Scale
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SAS = Simpson Angus Scale
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jonathan Jensen, M.D., University of Minnesota
- Directeur d'études: S. Charles Schulz, M.D., University of Minnesota
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Spectre de la schizophrénie et autres troubles psychotiques
- La schizophrénie
- Maladie
- Troubles psychotiques
- Les troubles mentaux
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents autonomes
- Agents du système nerveux périphérique
- Antiémétiques
- Agents gastro-intestinaux
- Agents antipsychotiques
- Agents tranquillisants
- Médicaments psychotropes
- Inhibiteurs de l'absorption de la sérotonine
- Inhibiteurs de l'absorption des neurotransmetteurs
- Modulateurs de transport membranaire
- Agents de sérotonine
- Agents antidépresseurs
- Agents dopaminergiques
- Antagonistes de la sérotonine
- Antagonistes de la dopamine
- Olanzapine
- Fumarate de quétiapine
- Rispéridone
Autres numéros d'identification d'étude
- 0205M26041
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