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Sponsored by: |
Johnson & Johnson Taiwan Ltd |
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Information provided by: | Johnson & Johnson Taiwan Ltd |
ClinicalTrials.gov Identifier: | NCT00757705 |
The purpose of the study is to explore the tolerability, safety and maintained efficacy of flexibly dosed paliperidone ER in patients with schizophrenia previously unsuccessfully treated with other oral atypical antipsychotic medication. Patients from any oral atypical antipsychotic medication can be transitioned to an effective dose of paliperidone ER without the need for titration.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Paliperidone ER |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexible Dosed Paliperidone ER in Subjects With Schizophrenia |
Estimated Enrollment: | 500 |
This is an open-label, non-randomized, single arm, multicenter, 24-week study. Atypical Antipsychotics (Second-Generation Antipsychotics) have been available in Taiwan for more than 10 years and gradually become the preferable treatment choices of patients with schizophrenia. However, there are still patients suffering from residual symptoms or severe side effects under such treatments. Therefore, the purpose of this study is to explore the efficacy and tolerability and the characteristics of response of paliperidone ER in patients with schizophrenia, as seen in a normal day-to-day practice, using flexible dosing regimens for a transition from different oral atypical antipsychotics to paliperidone ER (3~12 mg tablet once daily for 168 days).The primary objective of this study is to explore the maintained efficacy, based on total Positive and Negative Syndrome Scale (PANSS) score, of flexibly dosed paliperidone ER in non-acute patients with schizophrenia previously unsuccessfully treated with other atypical oral antipsychotics. Unsuccessfully treated means that, despite the patient was treated with an adequate dose of an appropriate oral antipsychotic for an adequate period of time, this previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability, lack of compliance and/or other reasons. Assessments of efficacy will be performed at screening and after 2, 4, 12 and 24 weeks. Secondary objectives are to explore the tolerability and safety of flexibly dosed paliperidone ER in patients with schizophrenia previously unsuccessfully treated with other oral atypical antipsychotics and to explore the characteristics of response in order to develop guidance for the optimal transition from previous atypical antipsychotic medication to flexibly dosed paliperidone ER. This will be done by assessing efficacy by means of the Positive and Negative Syndrome Scale (PANSS); proportion of subjects improving ≥ 20% in total PANSS from baseline to endpoint; general measures of treatment success by means of the Clinical Global Impression-Severity score (CGI-S); global assessment of functioning scale (GAF); personal and social functioning by means of the Personal and Social Performance (PSP) scale; health status by means of the self-rated SF-36 Health Survey; patient satisfaction; evaluation of sleep quality and daytime drowsiness by means of a self-rated 11-point Evaluation Scale; side effect profiles by means of the Extrapyramidal Symptom Rating Scale (ESRS), body weight, vital signs, physical examination and adverse events (AEs). Assessments of safety will be performed at screening and after 2, 4, 12 and 24 weeks.
The recommended dose of paliperidone ER is 6 mg once daily. Some patients may benefit from higher or lower doses within the recommended range of 3 to 12 mg tablet once daily for 168 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email | info1@veritasmedicine.com |
Study Director: | Johnson & Johnson Taiwan, Ltd. Clinical Trial | Johnson & Johnson Taiwan Ltd |
Study ID Numbers: | CR014308 |
Study First Received: | September 19, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00757705 History of Changes |
Health Authority: | Taiwan: Department of Health |
Paliperidone Paliperidone ER Schizophrenia |
Schizophrenia Tranquilizing Agents Mental Disorders Psychotropic Drugs Risperidone |
Central Nervous System Depressants 9-hydroxy-risperidone Psychotic Disorders Antipsychotic Agents Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Tranquilizing Agents Mental Disorders Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features |