- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00412373
Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
24. april 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
307
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Davao City, Filippinerne
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Mandaluyong, Filippinerne
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Manila, Filippinerne
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Pasig National Capitol Region, Filippinerne
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California
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Cerritos, California, Forenede Stater
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Costa Mesa, California, Forenede Stater
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Garden Grove, California, Forenede Stater
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Huntington Beach, California, Forenede Stater
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Pico Rivera, California, Forenede Stater
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San Diego, California, Forenede Stater
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Florida
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Aventura, Florida, Forenede Stater
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Hollywood, Florida, Forenede Stater
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Kissimmee, Florida, Forenede Stater
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Leesburg, Florida, Forenede Stater
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater
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South Carolina
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Charleston, South Carolina, Forenede Stater
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Texas
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Austin, Texas, Forenede Stater
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Irving, Texas, Forenede Stater
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Ahmedabad, Indien
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Ahmedibad, Indien
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Aurangabad, Indien
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Chennai, Indien
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Delhi, Indien
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Kanpur Uttarpradeh, Indien
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Pune, Indien
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Vadadora, Indien
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Chonju, Korea, Republikken
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Daegu, Korea, Republikken
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Gyeonggi-Do, Korea, Republikken
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Inchun, Korea, Republikken
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Kwangiu, Korea, Republikken
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Pusan, Korea, Republikken
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Seoul, Korea, Republikken
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Ipoh, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Arad, Rumænien
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Bucharest, Rumænien
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Campina, Rumænien
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Com Gura Ocnitei, Rumænien
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Iasi, Rumænien
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Pitesti, Rumænien
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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
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 001
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
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(3-12mg/day in 3 mg/day increments for 6 weeks)
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Eksperimentel: 003
Paliperidone ER (3-12mg/day in 3 mg/day increments for 6 weeks)
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(3-12mg/day in 3 mg/day increments for 6 weeks)
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Placebo komparator: 002
Placebo for 6 weeks
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for 6 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline.
Tidsramme: Baseline
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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.
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Baseline
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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.
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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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
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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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
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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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
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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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
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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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
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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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
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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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
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline
Tidsramme: Baseline
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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.
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Baseline
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder
Tidsramme: Week 6 or the last post-randomization assessment during double-blind treatment
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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.
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Week 6 or the last post-randomization assessment during double-blind treatment
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Participants With Response
Tidsramme: Week 6 LOCF End Point
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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).
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Week 6 LOCF End Point
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Baseline Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16
Tidsramme: Baseline
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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.
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Baseline
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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
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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Baseline Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16
Tidsramme: Baseline
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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.
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Baseline
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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.
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Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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
1. december 2006
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
15. december 2006
Først indsendt, der opfyldte QC-kriterier
15. december 2006
Først opslået (Skøn)
18. december 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2014
Sidst verificeret
1. april 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske processer
- Skizofrenispektrum og andre psykotiske lidelser
- Sygdom
- Psykotiske lidelser
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Dopaminmidler
- Serotonin 5-HT2-receptorantagonister
- Serotonin-antagonister
- Dopamin D2-receptorantagonister
- Dopamin-antagonister
- Paliperidon Palmitat
Andre undersøgelses-id-numre
- CR013099
- R076477SCA3002
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 .
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Johnson & Johnson Taiwan LtdAfsluttet
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Wei HaoAfsluttetMetamfetamin afhængighedKina
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Sage TherapeuticsAfsluttetEssential TremorForenede Stater
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Wei HaoAfsluttetMetamfetamin afhængighedKina