A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01606228
First received: May 16, 2012
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone ER
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly-Dosed Paliperidone ER Among Treatment-Naïve and Newly Diagnosed Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica:

Primary Outcome Measures:
  • The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90) [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.


Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) Scores at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

  • Positive and Negative Syndrome Scale (PANSS) Scores at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

  • Clinical Global Impression-Severity (CGIS) Scores at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".

  • Clinical Global Impression-Severity (CGIS) Scores at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".

  • Personal and Social Performance (PSP) Scores at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.

  • Personal and Social Performance (PSP) Scores at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.

  • Patient Satisfaction With Paliperidone Treatment [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).

  • Quality of Sleep at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).

  • Quality of Sleep at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).

  • Daytime Drowsiness at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).

  • Daytime Drowsiness at Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).


Enrollment: 188
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone ER Drug: Paliperidone ER
Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.

Detailed Description:

This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with schizophrenia
  • Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
  • Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
  • Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
  • Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study

Exclusion Criteria:

  • Serious unstable medical condition, including known clinically relevant laboratory abnormalities
  • Judged to be at high risk for adverse events, violence or self-harm
  • Inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication)
  • Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
  • Patients with a current use or known history (over the past 6 months) of substance dependence
  • Positive urine drug examination
  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: NCT01606228

Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica
  More Information

No publications provided

Responsible Party: Medical Director, Jan-Cil Philippines
ClinicalTrials.gov Identifier: NCT01606228     History of Changes
Other Study ID Numbers: CR014452, R076477SCH3033, PAL-PHL-MA3
Study First Received: May 16, 2012
Results First Received: August 3, 2012
Last Updated: September 19, 2012
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Janssen Pharmaceutica:
Schizophrenia
Paliperidone ER
Treatment naive patients
Newly diagnosed patients

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 August 28, 2014