A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00210769
First received: September 13, 2005
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to evaluate the long-term safety and tolerability and the maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone administered once daily to patients diagnosed with schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: paliperidone ER Oros
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: Open-label Extension of A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Extended Release OROS� Paliperidone (6 and 12 mg/Day) and Olanzapine (10 mg/Day), in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Standard safety evaluations, and monitoring of extrapyramidal symptoms (tardive dyskinesia, akathisia) by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS), throughout the long-term study.

Secondary Outcome Measures:
  • Assessment of long-term effectiveness by the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4).

Enrollment: 203
Study Start Date: January 2004
Study Completion Date: December 2005
Detailed Description:

The controlled rate of drug delivery provided by the extended-release oral formulation of paliperidone may provide improved effectiveness and a reduced risk of certain adverse effects in patients with schizophrenia, by avoiding peaks and troughs of drug levels in the blood. This could in turn provide an improved quality of life and overall functioning for patients.

This open-label study is an extension of a 6-week randomized, double-blind, parallel-group study in which the effectiveness and safety of 4 different oral treatments administered once daily are compared in patients with schizophrenia: paliperidone 6 or 12 milligrams (mg), olanzapine 10 mg (an approved treatment for schizophrenia), or placebo. Following the double-blind treatment phase, eligible patients may enter this 52-week open-label extension with slow, extended-release paliperidone (with no comparison treatments). In the open-label extension, all patients, regardless of their randomized treatment in the double-blind phase, will begin on extended-release paliperidone 9 mg once daily. Thereafter, patients will be maintained on a flexible dosage of extended-release paliperidone throughout the 52-week study. The dosage may be increased or decreased within this range in accordance with the clinical judgment of the investigator, based on observations of patient response and tolerability. Because flexible dosing more closely mimics clinical practice, this design may provide more clinically relevant findings in the open-label setting.The final visit in the double-blind phase may serve as the initial visit for the open-label extension. Study visits will occur at Day 4 and then weekly for the first 4 weeks (Weeks 1, 2, 3, and 4) and then every 4 weeks through Week 52 or until early termination. Evaluations of the safety and effectiveness of extended-release paliperidone treatment will be performed at scheduled times throughout the open-label extension. Flexible dosage (3, 6, 9, or 12 milligrams (mg)) extended-release paliperidone tablets administered orally once daily for 52 weeks, following a 6-week double-blind study in which patients receive fixed oral doses of 6 mg or 12 mg extended-release paliperidone or olanzapine 10 mg.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • As for the double-blind study, a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
  • experiencing an acute episode of schizophrenia at time of screening for the double-blind study, with a total PANSS score of 70 to 120
  • completed the double-blind study or discontinued after at least 21 days of double-blind treatment because of lack of efficacy
  • for female patients of childbearing potential, agreement to continue to use an acceptable form of contraception throughout the open-label extension, with a negative urine pregnancy test at open-label baseline.

Exclusion Criteria:

  • As for the double-blind study, a DSM-IV axis I diagnosis other than schizophrenia
  • a DSM-IV diagnosis of substance dependence within 6 months prior to screening for the double-blind study
  • considered by the investigator to be at significant risk for suicidal or violent behavior during the open-label study
  • received an injection of a depot antipsychotic since entry into the double-blind study
  • a woman who has become pregnant.
  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: NCT00210769

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00210769     History of Changes
Other Study ID Numbers: CR004426
Study First Received: September 13, 2005
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
schizophrenia
extended release
oral administration
antipsychotic agents
dementia praecox
mental disorders
paliperidone
PANSS

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 October 16, 2014