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An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexible Dosed Paliperidone ER in Patients With Schizophrenia (INSTAR)
This study is not yet open for participant recruitment.
Verified by Johnson & Johnson Taiwan Ltd, April 2009
First Received: September 19, 2008   Last Updated: April 30, 2009   History of Changes
Sponsored by: Johnson & Johnson Taiwan Ltd
Information provided by: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00757705
  Purpose

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

MedlinePlus related topics: Schizophrenia
Drug Information available for: Paliperidone
U.S. FDA Resources
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

Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • The maintained efficacy of flexibly dosed paliperidone ER in non-acute patients with schizophrenia previously unsuccessfully treated with other atypical oral antipsychotics at screening and after 2, 4, 12 and 24 weeks.

Secondary Outcome Measures:
  • To explore the tolerability and safety of flexibly dosed paliperidone ER in patients with schizophrenia previously unsuccessfully treated with other oral atypical antipsychotics at screening and after 2, 4, 12 and 24 weeks.

Estimated Enrollment: 500
Detailed Description:

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.

  Eligibility

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

Inclusion Criteria:

  • Patient meets the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for schizophrenia
  • Patient has been given an adequate dose of an appropriate oral atypical antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication

Exclusion Criteria:

  • On clozapine, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
  • Serious unstable medical condition, including known clinically relevant laboratory abnormalities
  • History or current symptoms of tardive dyskinesia
  • History of neuroleptic malignant syndrome
  • Patients with a current use or known history (over the past 6 months) of substance dependence except for nicotine, caffeine, and Betal Nut according to DSM-IV Criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757705

Contacts
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email info1@veritasmedicine.com

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

No publications provided

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

Keywords provided by Johnson & Johnson Taiwan Ltd:
Paliperidone
Paliperidone ER
Schizophrenia

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009