PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed Description
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This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia. The total study duration will be approximately of 104 weeks per participant. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); acute Treatment phase (single-oral dose of paliperidone for 12 weeks, dose ranging from 3 to 12 milligram); Extension phase 1 (12 weeks) and Maintenance treatment which will be followed by additional Extension phase 2 and long-term maintenance treatment. Efficacy of the participants will primarily be evaluated by Clinical Global Impression-Improvement (CGI-I) scale score. Participants' safety will be monitored throughout the study.

Official Title
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An Open Label, Prospective, Non-comparative Study to Evaluate Flexible Dose of Paliperidone Extended-Release and Clinical Response in the Treatment of Subjects With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Paliperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) Participants who are capable of and willing to fill out the questionnaire for themselves Participants who are compliant with self-medication or can receive consistent help or support Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) Exclusion Criteria: Participants with the past history of neuroleptic malignant syndrome (NMS) Participants with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration) Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.) Participants who have been exposed to the study drug within one month before screening Participants with significant risk including suicide or aggressive behavior

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paliperidone<br>Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion. | Drug: Paliperidone<br>* Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.<br>* Other names: Invega extended-Release (ER) tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Week 12 | 
| Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population | The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. | Baseline, Week 4 and 12 | 
| Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population | The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. | Baseline, Week 4 and Week 12 | 
| Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population | Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here. | Week 12 | 
| Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population | Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here. | Week 12 | 
| Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population | The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). | Baseline, Week 4 and 12 | 
| Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population | The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). | Baseline, Week 4 and 12 | 
| Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population | 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 participant. 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 participants. Higher scores indicate worsening. | Baseline, Week 2, 4, 8 and 12 | 
| Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population | 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 participant. 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 participants. Higher scores indicate worsening. | Baseline, Week 2, 4, 8 and 12 | 
| Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Week 12 | 
| Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paliperidone, R076477, Schizophrenia