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Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)

2. februar 2022 opdateret af: Organon and Co

Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (Protocol P06238)

This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in participants with schizophrenia. Participants in this study consist of schizophrenia with residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia. The treatment period is up to 52 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

157

Fase

  • Fase 3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Minimum age of 20 years

  • Participants who meet at least one of the following:

    • current diagnosis of schizophrenia of residual subtype
    • received treatment with 3 or more antipsychotic drugs
    • treatment-refractory participants with schizophrenia
    • 65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
  • Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline

Exclusion Criteria:

  • Uncontrolled, unstable clinically significant medical condition
  • Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
  • Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
  • Seizure disorder beyond childhood (12 years old or younger)
  • History of neuroleptic malignant syndrome
  • Allergy or sensitivity to drugs such as psychotropics and antipsychotics
  • Known history of or currently treated for narrow angle glaucoma
  • Parkinson's disease
  • Diagnosis of schizoaffective disorder; schizophreniform disorder
  • Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
  • Diagnosis of borderline personality disorder
  • Diagnosis of mental retardation or organic brain disorder
  • Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
  • Positive drug/alcohol tests at the Screening visit
  • Imminent risk of self-harm or harm to others, in the Investigator's opinion
  • Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
  • Currently under involuntary inpatient confinement
  • Use of a non-approved drug in Japan within 12 weeks prior to informed consent
  • Previously treated in an asenapine study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Asenapine
Asenapine 5 mg twice daily (BID) for the first week of treatment, then either 5 mg or 10 mg BID.
Medicin: Asenapine
5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal deltagere med ekstrapyramidale symptomer
Tidsramme: Op til 30 dage efter sidste dosis af undersøgelseslægemidlet (op til ca. 56 uger)
Dette mål rapporterer det samlede antal deltagere med nogen af ​​en gruppe af bivirkninger, der blev defineret til at repræsentere ekstrapyramidale symptomer. Antallet af deltagere med hver af de individuelle uønskede hændelser inden for denne definition er også præsenteret for termer, der opstod hos mindst én deltager. Til denne foranstaltning blev alle uønskede hændelser i Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for "extrapyramidalt syndrom" behandlet som ekstrapyramidale symptomer.
Op til 30 dage efter sidste dosis af undersøgelseslægemidlet (op til ca. 56 uger)
Change From Baseline in Weight at Week 52
Tidsramme: Baseline and Week 52
For each participant, change from baseline in weight was calculated as the Week 52 value minus the baseline value.
Baseline and Week 52
Change From Baseline in BMI at Week 52
Tidsramme: Baseline and Week 52
For each participant, change from baseline in BMI was calculated as the Week 52 value minus the baseline value.
Baseline and Week 52
Change From Baseline in HbA1c at Week 52
Tidsramme: Baseline and Week 52
Blood samples for determination of HbA1c were obtained at baseline and during the study. For each participant, change from baseline in HbA1c at Week 52 was calculated as the Week 52 value minus the baseline value.
Baseline and Week 52
Change From Baseline in Fasting Glucose at Week 52
Tidsramme: Baseline and Week 52
Blood samples for determination of fasting glucose level were obtained at baseline and during the study. For each participant, change from baseline in fasting glucose at Week 52 was calculated as the Week 52 level minus the baseline level.
Baseline and Week 52
Change From Baseline in Insulin at Week 52
Tidsramme: Baseline and Week 52
Blood samples for determination of insulin level were obtained at baseline and during the study. For each participant, change from baseline in insulin at Week 52 was calculated as the Week 52 level minus the baseline level.
Baseline and Week 52
Change From Baseline in Prolactin at Week 52
Tidsramme: Baseline and Week 52
Blood samples for determination of prolactin level were obtained at baseline and during the study. For each participant, change from baseline in prolactin at Week 52 was calculated as the Week 52 level minus the baseline level.
Baseline and Week 52
Change From Baseline in PANSS Total Score at Week 52
Tidsramme: Baseline and Week 52
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Week 52 (calculated for a participant as Week 52 value minus baseline value); improvement in symptoms is represented by negative values.
Baseline and Week 52
Change From Baseline in PANSS Total Score at Final Assessment
Tidsramme: Baseline up to Week 52
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at the final assessment for a participant (calculated for a participant as final assessment value minus baseline value); improvement in symptoms is represented by negative values.
Baseline up to Week 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Organon and Co

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. april 2011

Primær færdiggørelse (Faktiske)

21. august 2014

Studieafslutning (Faktiske)

21. august 2014

Datoer for studieregistrering

Først indsendt

18. november 2010

Først indsendt, der opfyldte QC-kriterier

18. november 2010

Først opslået (Skøn)

19. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P06238
  • 132325 (Registry Identifier: Japic-CTI)
  • MK-8274-042 (Anden identifikator: Merck protocol number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Asenapine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Arab Emirates

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner