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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

157

Fase

  • Fase 3

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall deltakere med ekstrapyramidale symptomer
Tidsramme: Opptil 30 dager etter siste dose av studiemedikamentet (opptil ca. 56 uker)
Dette målet rapporterer det totale antallet deltakere med noen av en gruppe uønskede hendelser som ble definert til å representere ekstrapyramidale symptomer. Antall deltakere med hver av de individuelle uønskede hendelsene innenfor denne definisjonen er også presentert, for termer som oppstod hos minst én deltaker. For dette tiltaket ble alle uønskede hendelsestermer i Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for "ekstrapyramidalt syndrom" behandlet som ekstrapyramidale symptomer.
Opptil 30 dager etter siste dose av studiemedikamentet (opptil ca. 56 uker)
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Organon and Co

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. april 2011

Primær fullføring (Faktiske)

21. august 2014

Studiet fullført (Faktiske)

21. august 2014

Datoer for studieregistrering

Først innsendt

18. november 2010

Først innsendt som oppfylte QC-kriteriene

18. november 2010

Først lagt ut (Anslag)

19. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. februar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. februar 2022

Sist bekreftet

1. februar 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • P06238
  • 132325 (Registeridentifikator: Japic-CTI)
  • MK-8274-042 (Annen identifikator: Merck protocol number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Forhold

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