A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396565
• Other study ID #: CR012625
• Secondary ID: JNS007ER-JPN-S31
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2006
• Last updated: April 10, 2014
• Start date: July 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2014
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

Description:

This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who have given their own consent in writing to participate in the study

• Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)

• Patients who have acute symptoms of schizophrenia

• Both inpatients and outpatients are acceptable

Exclusion Criteria:

• A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia

• A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test

• Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120

• Patients treated with three or more types of antipsychotic within 28 days before the screening test

• Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)

• Patients with a complication of or a past history of cerebrovascular accident

• Patients with a complication of or a past history of diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• ER OROS paliperidone
Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.
• Placebo
Form= tablet, route= oral use. Two tablets once daily for 6 weeks.
• Olanzapine
Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).	PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).	Baseline and 6 weeks	No
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score	The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).	Baseline and 6 weeks	No
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score	The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).	Baseline and 6 weeks	No
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score	The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).	Baseline and 6 weeks	No
Secondary	Proportion of Responders (=30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])	Responders are subjects with 30% or more reduction from baseline in total PANSS score. PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).	Baseline and 6 weeks	No
Secondary	Change From Baseline in Clinical Global Impression Scale (CGI-S)	The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe.	Baseline and 6 weeks	No

External Links

•   A Study to Evaluate Efficacy and Safety of ER OROS Paliperidone in Patients With Schizophrenia