Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.

24. april 2014 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Double-blind, Placebo-controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Flexible-dose Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder.

The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Schizophrenia and schizoaffective disorder are closely related in terms of symptoms, coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia, treatment with paliperidone extended-release (ER) improved psychotic symptoms, as well as mood symptoms evaluated by anxiety/depression and hostility/excitement Positive and Negative Symptoms of Schizophrenia (PANSS) factor scores. Therefore, paliperidone ER may also be effective in treating symptoms of schizoaffective disorder. Paliperidone's limited potential for drug-drug interaction is particularly important in this patient population, in which multiple drug therapy is relatively common. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo-controlled, parallel-group study is designed to examine the effectiveness and safety of paliperidone ER in adult patients with schizoaffective disorder who are experiencing an acute episode of this disorder. Patients in the study will be randomly assigned to 1 of 2 groups to receive 6 weeks of oral treatment with flexible dosages of paliperidone ER (3-12 mg/day) or with placebo. The primary efficacy outcome will be the change from baseline to Week 6, or the last post-randomization assessment during double-blind treatment (endpoint), in the PANSS total score. Safety will be assessed by monitoring adverse events, clinical laboratory testing, pregnancy testing, vital signs measurements, physical examination, administration of a 12-lead ECG, movement disorders side effect scales, and the InterSePT Scale for Suicidal Thinking. Patients may also choose to participate in a pharmacogenomic (DNA) analysis. The primary study hypothesis is that flexible-dose paliperidone ER is better than placebo on the change from baseline in the PANSS total score in acutely ill patients with schizoaffective disorder. Patients will receive study drug by mouth for a total of 43 days. Beginning on Day 1, patients will take either placebo or paliperidone ER 6 mg/day. After day 4, dosages may be adjusted, at defined intervals, to a dosage between 3 mg/day and 12 mg/day, inclusive.

Studietype

Intervensjonell

Registrering (Faktiske)

307

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Filippinene
      • Davao City, Filippinene
      • Mandaluyong, Filippinene
      • Manila, Filippinene
      • Pasig National Capitol Region, Filippinene
  • Forente stater
    • California
      • Cerritos, California, Forente stater
      • Costa Mesa, California, Forente stater
      • Garden Grove, California, Forente stater
      • Huntington Beach, California, Forente stater
      • Pico Rivera, California, Forente stater
      • San Diego, California, Forente stater
    • Florida
      • Aventura, Florida, Forente stater
      • Hollywood, Florida, Forente stater
      • Kissimmee, Florida, Forente stater
      • Leesburg, Florida, Forente stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater
    • South Carolina
      • Charleston, South Carolina, Forente stater
    • Texas
      • Austin, Texas, Forente stater
      • Irving, Texas, Forente stater
  • India
      • Ahmedabad, India
      • Ahmedibad, India
      • Aurangabad, India
      • Chennai, India
      • Delhi, India
      • Kanpur Uttarpradeh, India
      • Pune, India
      • Vadadora, India
  • Korea, Republikken
      • Chonju, Korea, Republikken
      • Daegu, Korea, Republikken
      • Gyeonggi-Do, Korea, Republikken
      • Inchun, Korea, Republikken
      • Kwangiu, Korea, Republikken
      • Pusan, Korea, Republikken
      • Seoul, Korea, Republikken
  • Malaysia
      • Ipoh, Malaysia
      • Kota Kinabalu, Malaysia
      • Kuala Lumpur, Malaysia
      • Kuching, Malaysia
  • Romania
      • Arad, Romania
      • Bucharest, Romania
      • Campina, Romania
      • Com Gura Ocnitei, Romania
      • Iasi, Romania
      • Pitesti, Romania

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

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder
  • A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of >= 60
  • A score of >= 16 on Young Mania Rating Scale (YMRS) or a score of >= 16 on the Hamilton Depression Rating Scale (HAM-D 21)

Exclusion Criteria:

  • A primary active mental illness diagnosis other than schizoaffective disorder
  • Patients with first episode psychosis
  • Active substance dependence within previous 6 months
  • Treatment with clozapine within 6 months of randomization
  • A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication
  • Pregnancy, breast-feeding, or planning to become pregnant

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 001
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Legemiddel: Paliperidone ER
(3-12mg/day in 3 mg/day increments for 6 weeks)
Eksperimentell: 003
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Legemiddel: Paliperidone ER
(3-12mg/day in 3 mg/day increments for 6 weeks)
Placebo komparator: 002
Placebo for 6 weeks
Legemiddel: Placebo
for 6 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.
Tidsramme: Baseline
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Baseline
Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline
Tidsramme: Baseline
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects". Higher scores indicate worsening.
Baseline
Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects". Higher scores indicate worsening.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder
Tidsramme: Week 6 or the last post-randomization assessment during double-blind treatment
The CGI-C rating scale is a 7 point global assessment that measures the clinician's impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to "No change". Ratings of <4 are equivalent to "improvement" and ratings of > 4 are equivalent to "worsening". Higher scores indicate worsening.
Week 6 or the last post-randomization assessment during double-blind treatment
Participants With Response
Tidsramme: Week 6 LOCF End Point
Response is defined as a 30% or more reduction from baseline PANSS total score and CGI-C score of <= 2 (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder).
Week 6 LOCF End Point

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
Tidsramme: Baseline
Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.
Baseline
Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
Tidsramme: Baseline
11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.
Baseline
Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Tidsramme: Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.
Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment

Samarbeidspartnere og etterforskere

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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Samarbeidspartnere

Janssen, LP

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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

1. desember 2006

Primær fullføring (Faktiske)

1. juni 2008

Studiet fullført (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først innsendt

15. desember 2006

Først innsendt som oppfylte QC-kriteriene

15. desember 2006

Først lagt ut (Anslag)

18. desember 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. mai 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. april 2014

Sist bekreftet

1. april 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR013099
  • R076477SCA3002

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. .

Kliniske studier på Paliperidone ER

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Cameroon

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere