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A 52 Week Open Label Extension Trial Following the Recurrence Prevention Study R076477-SCH-301 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645307
First Posted: March 27, 2008
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  Purpose
The purpose of the study was an Open Label Extension to the recurrence prevention study to evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia.

Condition Intervention Phase
Schizophrenia Drug: Extended Release OROS® Paliperidone Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Evaluating Extended Release OROS® Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia - Open Label Phase

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia

Secondary Outcome Measures:
  • Long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, quality of life, health economics, and subjective sleep measures

Enrollment: 235
Study Start Date: May 2004
Study Completion Date: August 2006
Detailed Description:

The primary objective of the open-label extension was the long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia. In addition, the long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, as well as quality of life, health economics, and subjective sleep measures, was explored. This open-label extension study followed a recurrence prevention study (R076477-SCH-301) that had both an open-label run-in/stabilization phase and a double-blind, placebo-controlled phase.

Open-label study drug (ER OROS paliperidone 3 mg to 15 mg/day) was administered for 52 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who had experienced a recurrence event during the double blind phase of Study R076477-SCH-301
  • Remained recurrence free until the end of the double-blind phase, or were in the run-in or stabilization phases when the study was terminated
  • Who signed the informed consent for the open-label extension
  • And who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open-label extension

Exclusion Criteria:

  • Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial
  • Were pregnant or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645307


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00645307     History of Changes
Other Study ID Numbers: CR003289
First Submitted: March 24, 2008
First Posted: March 27, 2008
Last Update Posted: June 8, 2011
Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
paliperidone
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Recurrence
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents