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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Open Label Extension to R076477-SCH-305 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Paliperidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paliperidone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paliperidone, schizophrenia