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

NCT00473434 | Completed Phase 3 Results

• 2 other identifiers: CR013213R076477SCH3021
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Drug Therapy; Treatment Outcome

Outcome Measures

Primary Outcomes (6)

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

  Day 1 to Day 84

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

  Day 1 to Day 84

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

  Day 57 to Day 84

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

  Day 57 to Day 84

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

  Week 0 to Week 12

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

  Week 0 to Week 12

Secondary Outcomes (5)

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

  52 weeks

• The Global Assessment of Functioning (GAF) Throughout the Study

  52 Weeks

• The Percentage of Participants Presenting Clinical Deterioration Throughout the Study

  52 Weeks

• The Number of Hospitalizations Throughout the Study

  52 Weeks

• The Length of Hospitalizations Throughout the Study

  52 weeks

Study Arms (1)

001

EXPERIMENTAL

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

Drug: Paliperidone

Interventions

Paliperidone DRUG

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

001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Cilag Pty Ltd: lead

Related Links

• An open label multicentre study to determine the dose distribution of Paliperidone ER OROS® in patients with schizophrenia

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Regional Medical Affairs Therapeutic Lead Immunol
• Organization: Jan-Cil Australia

61 2 88753219

Study Officials

• Janssen-Cilag Pty Ltd Clinical Trial

  Janssen-Cilag Pty Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2007
• First Posted: May 15, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 5, 2012
• Results First Posted: October 8, 2012

Record last verified: 2012-12