A 52 Week Open-label Extension Trial Following the Double-blind Efficacy and Safety Study R076477-SCH-305.

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. Identifier: NCT00668837
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : June 8, 2011
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
Open-Label Extension to the double-blind effectiveness and safety study R076477-SCH-305 to evaluate long-term safety and tolerability in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Paliperidone Phase 3

Detailed Description:
The primary objective of the open-label extension trial was the long-term assessment of safety and tolerability of flexibly-dosed ER OROS paliperidone (3 to 15 mg/day) in patients with a diagnosis of schizophrenia. Other measures assessed in the extension study included: change in the total Positive and Negative Syndrome Scale (PANSS) score; change in PANSS subscale (positive and negative) scores; overall functioning, as measured by the Clinical Global Impression Scale-Severity (CGI-S); personal and social functioning, as measured by the Personal and Social Performance Scale (PSP); and quality of life parameters, as measured by the Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4). Paliperidone ER OROS® tablet formulation (3 to 15 mg/day) to be taken orally for 52 weeks

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Extension to R076477-SCH-305 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.
Study Start Date : February 2004
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. Flexibly-dosed ER OROS paliperidone 3 mg to 15 mg/day was safe and well tolerated in patients with schizophrenia. The safety profile was generally consistent with that observed in subjects after short-term use in the double-blind studies

Secondary Outcome Measures :
  1. Findings showed stability of symptoms or further improvements in the severity of symptoms associated with schizophrenia (PANSS), personal and social functioning (PSP), global severity of illness (CGI-S), and patient-rated symptoms and well-being (SQLS)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Study R076477-SCH-707 enrolled patients who met the DSM-IV criteria of schizophrenia for at least 1 year
  • Eligible patients were experiencing active symptoms at the time of enrollment and had a PANSS total score between 70 and 120
  • The open-label extension study population comprised patients who had completed the 6-week double-blind phase of the study or who had discontinued due to lack of efficacy after at least 21 days of treatment.

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

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 identifier (NCT number): NCT00668837

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00668837     History of Changes
Other Study ID Numbers: CR002944
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: March 2010

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

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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