An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00257023
First received: November 18, 2005
Last updated: May 16, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to assess the safety, effectiveness, and plasma concentration of paliperidone (an antipsychotic medication) given once daily in the treatment of patients with schizophrenia


Condition Intervention Phase
Schizophrenia
Drug: paliperidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Study of Paliperidone in Patients With Schizophrenia to Investigate the Safety and Efficacy

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Safety assessments conducted throughout the study, including adverse events and results from the Drug-Induced Extrapyramidal Symptoms Scale [DIESS]

Secondary Outcome Measures:
  • Changes measured throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a score on a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score.

Enrollment: 52
Study Start Date: February 2005
Study Completion Date: September 2005
Detailed Description:

Paliperidone is an extended-release tablet. Paliperidone is an active metabolite of risperidone, not approved for the treatment of schizophrenia in Japan. This is a multicenter, open-label, parallel-group, fixed dose study to evaluate the safety, effectiveness, and plasma concentration of paliperidone taken once daily in patients with schizophrenia. The patients will receive a fixed dose of paliperidone (3, 9, and 15 mg) for 6 weeks and its effectiveness and safety will be observed for an additional 2 weeks.. Efficacy will be measured by determining changes throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score. In addition, the study also assesses the relationship between dose/plasma drug concentration and dopamine D2 receptor occupancy in patients who consent to receive positron emission tomography (PET). Safety evaluations (symptoms, physical exams, electrocardiograms, laboratory tests, Drug-Induced Extrapyramidal Symptoms Scale [DIESS] results, and adverse event monitoring) will be conducted throughout the study. The study hypothesis is that paliperidone will be effective in the treatment of schizophrenia, and that it will be well-tolerated. The patients will receive either 3, 9, or 15 mg of paliperidone, taken once daily by mouth for 6 weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV
  • taking not more than one oral antipsychotic medication within 28 days of study entry
  • a score below 120 at pre-treatment on the Positive and Negative Syndrome Scale Score (PANSS), a scale for the measurement of symptoms of schizophrenia

Exclusion Criteria:

  • Diagnosis of psychiatric disease other than schizophrenia according to the diagnostic criteria of DSM-IV
  • history of Parkinson's disease, seizure disorder, cerebrovascular accident, diabetes mellitus, clinically significant gastrointestinal disorders, or severe impairment of the liver or kidneys
  • drug allergy or hypersensitivity to antipsychotics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257023

Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00257023     History of Changes
Other Study ID Numbers: CR004939
Study First Received: November 18, 2005
Last Updated: May 16, 2011
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by Janssen Pharmaceutical K.K.:
Schizophrenia
Risperidone
Positive and Negative Syndrome Scale (PANSS)
Clinical Global Impression (CGI)
Positron Emission Tomography (PET)

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014