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CompletedNCT00473434Updated Dec 5, 2012Results posted

An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia

A Phase 3 interventional study of Paliperidone in Schizophrenia, sponsored by Janssen-Cilag Pty Ltd. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-12-05.

Sponsored by Janssen-Cilag Pty Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. In this study patients and physicians know the name and the dose of the study drug. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The safety assessments to be conducted throughout this study including the regular monitoring and recording of all Adverse Events and Serious Adverse Events.

Read the detailed description

This trial is a non-randomised (both patient and physician know the study drug), single arm, open label multicentre study which is aimed to evaluate the dose distribution, efficacy and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase will be 40 weeks. Assessment of efficacy and safety will be performed in Phase A at baseline, 2, 4, 6, 9 and 12 weeks and in Phase B at 20, 28, 36, 44 and 52 weeks. At the first visit, a full psychiatric history, demographic data and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will be performed: descriptions of concomitant medications; hospitalisations for psychiatric reasons; clinical deterioration; Clinical Global Impression - Severity (CGI-S) and Global Assessment of Functioning (GAF) assessments; Community Treatment Order (CTO) status; weight; adherence and adverse event reporting. Physical examinations will be performed periodically. Paliperidone ER OROS will be supplied in 3 mg, 6 mg, and 9 mg tablets for oral administration. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase

02

Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia
  • Drug Therapy
  • Treatment Outcome
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 64 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Janssen-Cilag Pty Ltd is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must satisfy the following criteria to be eligible for this study: patients with diagnoses of schizophrenia according to the DSM-IV criteria including newly diagnosed patients
  • Out-patients or in-patients with expected discharge within 8 weeks
  • Patients or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients who meet any of the following criteria will be excluded from participating in the study: patients who are resistant to antipsychotic treatment
  • Patients who have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months
  • Patients with CGl-S scores > 6 or who who have been hospitalized for longer than 8 continuous weeks during the past 6 months
  • Pregnant or breast-feeding females
  • Patients with a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    001

    Paliperidone3mg or 6mg or 9mg or 12mg once daily for 52 weeks

    Drug: Paliperidone

Interventions

  • DrugPaliperidone

    3mg or 6mg or 9mg or 12mg once daily for 52 weeks

06

What researchers measure

Primary outcomes

  1. The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84

    Time frame: Day 1 to Day 84

  2. The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84

    Time frame: Day 1 to Day 84

  3. The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84

    Time frame: Day 57 to Day 84

  4. The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84

    Time frame: Day 57 to Day 84

  5. The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12

    Time frame: Week 0 to Week 12

  6. The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12

    Time frame: Week 0 to Week 12

Secondary outcomes

  1. The Clinical Global Impression of Severity (CGI-S) Throughout the Study

    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 patient. 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 patients".

    Time frame: 52 weeks

  2. The Global Assessment of Functioning (GAF) Throughout the Study

    The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.

    Time frame: 52 Weeks

  3. The Percentage of Participants Presenting Clinical Deterioration Throughout the Study

    This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms.

    Time frame: 52 Weeks

  4. The Number of Hospitalizations Throughout the Study

    This outcome measure is intended to document all hospitalizations that occurred throughout the study.

    Time frame: 52 Weeks

  5. The Length of Hospitalizations Throughout the Study

    Time frame: 52 weeks

07

Results

Posted Oct 8, 2012

Participant flow

Participant flow — Overall Study
MilestonePaliperidone Extended Release (ER)
Started64
Completed32
Not completed32
Withdrew: Physician decision3
Withdrew: Withdrawal by subject9
Withdrew: Compliance3
Withdrew: Lack of efficacy3
Withdrew: Adverse event3
Withdrew: Patient was selling medication to others1
Withdrew: Safety evaluation1
Withdrew: Reason not specified6
Withdrew: Ceased in favor of paliperidone1
Withdrew: Switching to trial medication1
Withdrew: No longer required1

Outcome measures

PrimaryThe Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
Time frame:
Day 1 to Day 84
Reported as:
Mean · mg
The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
mgPaliperidone Extended Release (ER)
The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 846.9 ± 2.3
PrimaryThe Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
Time frame:
Day 1 to Day 84
Reported as:
Median · mg
The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
mgPaliperidone Extended Release (ER)
The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 846 (3 to 12)
PrimaryThe Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
Time frame:
Day 57 to Day 84
Reported as:
Mean · mg
The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
mgPaliperidone Extended Release (ER)
The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 847.5 ± 2.4
PrimaryThe Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
Time frame:
Day 57 to Day 84
Reported as:
Median · mg
The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
mgPaliperidone Extended Release (ER)
The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 846 (3 to 12)
PrimaryThe Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
Time frame:
Week 0 to Week 12
Reported as:
Mean · mg
The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
mgPaliperidone Extended Release (ER)
The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 126.8 ± 1.8
PrimaryThe Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
Time frame:
Week 0 to Week 12
Reported as:
Median · mg
The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
mgPaliperidone Extended Release (ER)
The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 126 (3.6 to 10.3)
SecondaryThe Clinical Global Impression of Severity (CGI-S) Throughout the Study

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 patient. 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 patients".

Time frame:
52 weeks
Reported as:
Mean · scores on a scale
The Clinical Global Impression of Severity (CGI-S) Throughout the Study
scores on a scaleBaselineWeek 2Week 4Week 6Week 9Week 12Week 20Week 28Week 36Week 44Week 52
The Clinical Global Impression of Severity (CGI-S) Throughout the Study3.7 ± 1.23.3 ± 1.13.2 ± 1.03.1 ± 1.12.8 ± 1.02.8 ± 1.02.9 ± 1.12.7 ± 1.12.7 ± 0.82.9 ± 1.22.7 ± 0.8
SecondaryThe Global Assessment of Functioning (GAF) Throughout the Study

The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.

Time frame:
52 Weeks
Reported as:
Mean · scores on a scale
The Global Assessment of Functioning (GAF) Throughout the Study
scores on a scaleBaselineWeek 2Week 4Week 6Week 9Week 12Week 20Week 28Week 36Week 44Week 52
The Global Assessment of Functioning (GAF) Throughout the Study54.6 ± 14.758.9 ± 15.063.9 ± 15.363.9 ± 15.666.3 ± 13.865.4 ± 14.665.1 ± 14.771.1 ± 13.371.6 ± 14.969.0 ± 17.263.3 ± 15.7
SecondaryThe Percentage of Participants Presenting Clinical Deterioration Throughout the Study

This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms.

Time frame:
52 Weeks
Reported as:
Number · percentage of participants
The Percentage of Participants Presenting Clinical Deterioration Throughout the Study
percentage of participantsBaselineWeek 2Week 4Week 6Week 9Week 12Week 20Week 28Week 36Week 44Week 52
Hospitalized0 ± 14.75.3 ± 15.013.5 ± 15.35.9 ± 15.67.1 ± 13.83.2 ± 14.63.7 ± 14.70 ± 13.30 ± 14.90 ± 17.212.5 ± 15.7
Care Increase005.42.93.63.27.4005.912.5
Suicidal4.85.38.100000000
Violent00000000000
Self Injury000003.200000
SecondaryThe Number of Hospitalizations Throughout the Study

This outcome measure is intended to document all hospitalizations that occurred throughout the study.

Time frame:
52 Weeks
Reported as:
Number · events
The Number of Hospitalizations Throughout the Study
eventsBaselineWeek 2Week 4Week 6Week 9Week 12Week 20Week 28Week 36Week 44Week 52
The Number of Hospitalizations Throughout the Study15 ± 14.72 ± 15.06 ± 15.32 ± 15.63 ± 13.81 ± 14.61 ± 14.70 ± 13.30 ± 14.91 ± 17.22 ± 15.7
SecondaryThe Length of Hospitalizations Throughout the Study
Time frame:
52 weeks
Reported as:
Mean · days
The Length of Hospitalizations Throughout the Study
daysBaselineWeek 2Week 4Week 6Week 9Week 12Week 20Week 44Week 52
The Length of Hospitalizations Throughout the Study12.4 ± 11.566 ± 07.3 ± 6.028.0 ± 5.7179.0 ± 220.634 ± 019 ± 04 ± 020.5 ± 10.6

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Paliperidone Extended Release (ER)—27/64 (42.2%)51/64 (79.7%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPaliperidone Extended Release (ER)
Suicidal ideationPsychiatric disorders5/64
SchizophreniaPsychiatric disorders3/64
DepressionPsychiatric disorders2/64
Mental disordersPsychiatric disorders2/64
ParanoiaPsychiatric disorders2/64
Schizoaffective disorderPsychiatric disorders2/64
Abdominal painGastrointestinal disorders1/64
LethargyGeneral disorders1/64
Encephalitis viralInfections and infestations1/64
Intentional overdoseInjury, poisoning and procedural complications1/64
Most frequent other events
Most frequent other events
EventPaliperidone Extended Release (ER)
InsomniaPsychiatric disorders10/64
HeadacheNervous system disorders7/64
NauseaGastrointestinal disorders6/64
TremorNervous system disorders6/64
AkathisiaPsychiatric disorders6/64
DizzinessCardiac disorders4/64
SedationNervous system disorders4/64
Vision blurredNervous system disorders4/64
RashSkin and subcutaneous tissue disorders4/64

Baseline characteristics

Age Continuous
Age Continuous(years)Paliperidone Extended Release (ER)
Mean37.0 ± 10.4
Sex: Female, Male
Sex: Female, Male(Participants)Paliperidone Extended Release (ER)
Female36
Male28
08

Study locations

No study locations are listed for this record.

09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00473434
Lead sponsor
Janssen-Cilag Pty Ltd
Responsible party
Sponsor
First posted
May 15, 2007
Start date
Apr 2007
Primary completion
Aug 2009
Completion
Aug 2009
Results posted
Oct 8, 2012
Last update
Dec 5, 2012

Study contacts

Janssen-Cilag Pty Ltd Clinical Trial
study director · Janssen-Cilag Pty Ltd

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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