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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier:
NCT00473434
First received: May 11, 2007
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 [ Time Frame: Day 1 to Day 84 ] [ Designated as safety issue: No ]
  • The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 [ Time Frame: Day 1 to Day 84 ] [ Designated as safety issue: No ]
  • The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 [ Time Frame: Day 57 to Day 84 ] [ Designated as safety issue: No ]
  • The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 [ Time Frame: Day 57 to Day 84 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Clinical Global Impression of Severity (CGI-S) Throughout the Study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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".

  • The Global Assessment of Functioning (GAF) Throughout the Study [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    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.

  • The Percentage of Participants Presenting Clinical Deterioration Throughout the Study [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    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.

  • The Number of Hospitalizations Throughout the Study [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    This outcome measure is intended to document all hospitalizations that occurred throughout the study.

  • The Length of Hospitalizations Throughout the Study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: April 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
Paliperidone3mg or 6mg or 9mg or 12mg once daily for 52 weeks
Drug: Paliperidone
3mg or 6mg or 9mg or 12mg once daily for 52 weeks

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473434

Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00473434     History of Changes
Other Study ID Numbers: CR013213, R076477SCH3021
Study First Received: May 11, 2007
Results First Received: June 26, 2012
Last Updated: December 4, 2012
Health Authority: Australia: Department of Health

Keywords provided by Janssen-Cilag Pty Ltd:
Schizophrenia
Drug Therapy
Treatment Outcome

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 26, 2014