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

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

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).

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Paliperidone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 491
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon-Si Gyeonggi-Do, Korea, Republic of
  • Changnyung, Korea, Republic of
  • Chungnam, Korea, Republic of
  • Chunjoo, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Daejun, Korea, Republic of
  • Geonggi-Do, Korea, Republic of
  • Gyeonggi-Do, Korea, Republic of
  • Incheon, Korea, Republic of
  • Inchun, Korea, Republic of
  • Jinju, Korea, Republic of
  • Kwangjoo, Korea, Republic of
  • Kyounggi, Korea, Republic of
  • Kyunggi-Do, Korea, Republic of
  • Kyungju, Korea, Republic of
  • Kyungki, Korea, Republic of
  • Kyunki, Korea, Republic of
  • Pusan, Korea, Republic of
  • Seoul, Korea, Republic of
  • Ulsan, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Paliperidone; 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; 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.; Other Names: R076477; Invega extended-Release (ER) tablet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (ESTIMATE): September 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 5, 2014
• Last Update Submitted That Met QC Criteria: January 22, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Schizophrenia; Paliperidone; R076477
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: CR015079; PAL-KOR-4001