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L'essai clinique NCT03784222 pour First Episode Schizophrenia, Social Function, Cognition Function, Blonanserin est interrompu. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Sumitomo PharmaEffects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients Phase IV 102 Multicentrique Ouvert
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT03784222 est conçu pour étudier le traitement de First Episode Schizophrenia, Social Function, Cognition Function, Blonanserin. Il s'agit d'une étude interventionnel en Phase IV. Son statut actuel est : interrompu. L'étude a débuté le 22 janvier 2019 et vise à recruter 102 participants. Dirigée par Sumitomo Pharma, l'étude devrait être terminée d'ici le 22 novembre 2022. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 19 avril 2024.
Résumé succinct
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
Titre officiel
Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients
Pathologies
First Episode SchizophreniaSocial FunctionCognition FunctionBlonanserinPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- DSPCLON-002
Numéro NCT
Date de début (réel)
2019-01-22
Dernière mise à jour publiée
2024-04-19
Date de fin (estimée)
2022-11-22
Inscription (estimée)
102
Type d'étude
Interventionnel
PHASE
Phase IV
Statut
Interrompu
Objectif principal
Traitement
Méthode d'allocation
Non randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Expérimentaltreatment group 188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test | Blonanserin patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability MRI and serum BDNF 60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test |
Autrecontrol group 60 subjects without schizophrenia, only receiving MRI and/or serum BDNF | MRI and serum BDNF 60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
changes in personal and social performance (PSP) scores at week 26 | PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome | 26 weeks |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group | MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms | 26 weeks |
changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group | PASAT is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention | 26 weeks |
changes in Groove Pegboard Test (GPT) at week 26 in treatment group | GPT is a test used to assess fine motor skills and speed. this test measure the time it takes to put 25 nails in the pegborad in a defined order | 26 weeks |
changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group | PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales. | 26 weeks |
changes in PANSS five-factor model scores at week 26 in treatment group | five-factor model is another model of PANSS. It is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales. | 26 weeks |
changes in PSP at every visit in treatment group during 26 weeks | PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome | baseline, week 8, week 26 |
changes in MCCB at every visit in treatment group during 26 weeks | MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms | baseline, week 8, week 26 |
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- Schizophrenia patients diagnosis either with DSM-5 criteria or ICD-10;
- PANSS total score ≥70;
- Males or Females aged 18-45 years;
- With disease course less than 5 years and during their first episode;
- ≥9 years of education;
- Without receiving systematic antipsychotic treatment, or receiving continuous antipsychotic treatment for less than 6 weeks and receiving antipsychotic treatment for less than 6 months in total;
- Ability to read and understand Chinese;
- Provision of written informed consent
- Severe or unstable physical diseases judged by investigators;
- Loss of consciousness more than 1 hour due to any reason in the past 1 year;
- Current substance misuse (in 3 months) or any substance dependence;
- Pregnant or lactating woman;
- Patients with attempted suicide history, severe suicidal ideation or behaviour;
- Mental retardation;
- Contradict to the study drugs;
- Patients taken other investigation products in the past 30 days before entry;
- Patients ever taken blonanserin before;
- Any current medical condition that would interfere with the assessment of efficacy;
- Physical symptoms of acute deterioration requiring hospitalization or increased intensive care;
- Significant muscle tension or Parkinson's disease;
- Clinically significant abnormal laboratory test results (blood, urine, and blood biochemical analysis);
- Clinically significant Abnormal electrocardiogram as judged by researchers;
- Participants continuously using sedative drugs, or anticholinergic agents within 3 months of the study;
- Those who had undergone electroconvulsive therapy within 3 month of the study;
- Those who had received long-acting injection treatment within 3 month of the study;
- Those who could not swallow medication with water;
- Subjects judged by the investigator in charge as inappropriate for the study
Sumitomo PharmaAucune donnée de contact disponible
8 Centres de l'étude dans 1 pays
Beijing Municipality
Beijing Huilongguan Hospital, Beijing, Beijing Municipality, 100096, China
Peking University Sixth Hospital, Beijing, Beijing Municipality, China
Hunan
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
Shanghai Municipality
Shanghai Mental Health Center, Shanghai, Shanghai Municipality, 200000, China
Shanxi
Xi'an Mental Health Center, Xi’an, Shanxi, China
Sichuan
West China Hospital, Sichuan Univeristy, Chengdu, Sichuan, China
Tianjin Municipality
Tianjin Mental Health Center, Tianjin, Tianjin Municipality, China
Zhejiang
The First Affiliated hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China