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

24 aprile 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

307

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Corea, Repubblica di
      • Chonju, Corea, Repubblica di
      • Daegu, Corea, Repubblica di
      • Gyeonggi-Do, Corea, Repubblica di
      • Inchun, Corea, Repubblica di
      • Kwangiu, Corea, Repubblica di
      • Pusan, Corea, Repubblica di
      • Seoul, Corea, Repubblica di
  • Filippine
      • Davao City, Filippine
      • Mandaluyong, Filippine
      • Manila, Filippine
      • Pasig National Capitol Region, Filippine
  • India
      • Ahmedabad, India
      • Ahmedibad, India
      • Aurangabad, India
      • Chennai, India
      • Delhi, India
      • Kanpur Uttarpradeh, India
      • Pune, India
      • Vadadora, India
  • 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
  • Stati Uniti
    • California
      • Cerritos, California, Stati Uniti
      • Costa Mesa, California, Stati Uniti
      • Garden Grove, California, Stati Uniti
      • Huntington Beach, California, Stati Uniti
      • Pico Rivera, California, Stati Uniti
      • San Diego, California, Stati Uniti
    • Florida
      • Aventura, Florida, Stati Uniti
      • Hollywood, Florida, Stati Uniti
      • Kissimmee, Florida, Stati Uniti
      • Leesburg, Florida, Stati Uniti
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti
    • South Carolina
      • Charleston, South Carolina, Stati Uniti
    • Texas
      • Austin, Texas, Stati Uniti
      • Irving, Texas, Stati Uniti

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 001
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Droga: Paliperidone ER
(3-12mg/day in 3 mg/day increments for 6 weeks)
Sperimentale: 003
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
Droga: Paliperidone ER
(3-12mg/day in 3 mg/day increments for 6 weeks)
Comparatore placebo: 002
Placebo for 6 weeks
Droga: Placebo
for 6 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.
Lasso di tempo: 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.
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Collaboratori

Janssen, LP

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2006

Completamento primario (Effettivo)

1 giugno 2008

Completamento dello studio (Effettivo)

1 giugno 2008

Date di iscrizione allo studio

Primo inviato

15 dicembre 2006

Primo inviato che soddisfa i criteri di controllo qualità

15 dicembre 2006

Primo Inserito (Stima)

18 dicembre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

9 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 aprile 2014

Ultimo verificato

1 aprile 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR013099
  • R076477SCA3002

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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