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Die klinische Studie NCT03784222 für First Episode Schizophrenia, Social Function, Cognition Function, Blonanserin ist abgebrochen. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients Phase 4 102 Multizentrisch Offene Studie

Abgebrochen
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Die klinische Studie NCT03784222 untersucht Behandlung im Zusammenhang mit First Episode Schizophrenia, Social Function, Cognition Function, Blonanserin. Diese interventionsstudie der Phase 4 hat den Status abgebrochen und startete am 22. Januar 2019. Es ist geplant, 102 Teilnehmer aufzunehmen. Durchgeführt von Sumitomo Pharma wird der Abschluss für 22. November 2022 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. April 2024 aktualisiert.
Kurzbeschreibung
This is an open label, multi-center study to explore the effects on social functions of blonanserin in first episode schizophrenia patients
Offizieller Titel

Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients

Erkrankungen
First Episode SchizophreniaSocial FunctionCognition FunctionBlonanserin
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • DSPCLON-002
NCT-Nummer
NCT03784222
Studienbeginn (tatsächlich)
2019-01-22
Zuletzt aktualisiert
2024-04-19
Studienende (vorauss.)
2022-11-22
Geplante Rekrutierung
102
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Abgebrochen
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Experimentelltreatment 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
Anderecontrol 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
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • 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 Pharma (Suzhou) Co., Ltd. logoSumitomo Pharma
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8 Studienstandorte in 1 Ländern

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