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Symptomatic Remission and Social Function in Patients Treated With Paliperidone ER

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT01577186
First received: April 12, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

The purpose of this study is to explore the relationship between achieving symptomatic remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and personal and social functioning by means of the Personal and Social Performance (PSP) scale in patients treated with flexibly dosed Paliperidone ER.


Condition Intervention Phase
Schizophrenia
 Drug: Paliperidone ER
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Symptomatic Remission and Social Function in Patients Treated With Paliperidone ER

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The PANSS is a 30-item scale 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.

  • Change from baseline in Personal and Social Performance (PSP) Scale [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    This scale assesses the degree of difficulty a patient exhibits over a 1-month period 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. Patients with scores 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.


Enrollment: 482
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone ER Drug: Paliperidone ER
Type= exact number, unit= mg, number= 6, form= tablet, route= oral use. The recommended paliperidone ER dose is 6 mg once daily. Some patients may benefit from lower or higher doses in the recommended dose range of 3 to 12 mg once daily.

Detailed Description:

This is an open label (all people know the identity of the intervention), multicenter, 12-week study. Patients can be either in- or outpatients. Throughout the study flexible dosing of paliperidone extended release (ER) in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to individually adjust the dosage of each patient. The recommended dose of paliperidone ER is 6 mg once daily.

  Eligibility

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

Inclusion Criteria:

  • Patients diagnosed with schizophrenia
  • Patient is drug naïve or patient's previous treatment is considered unsuccessful due to lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons
  • Signed informed consent stating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study
  • Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
  • Women must have a negative urine pregnancy test at screening

Exclusion Criteria:

  • Use of Clozapine, Paliperidone ER, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
  • Serious unstable medical condition, including known clinically relevant laboratory abnormalities
  • History of neuroleptic malignant syndrome
  • Known hypersensitivity to paliperidone ER or risperidone
  • Inability to swallow the whole study medication tablet with aid of water
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577186

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

Responsible Party: Medical Director, Jan-Cil Taiwan
ClinicalTrials.gov Identifier: NCT01577186     History of Changes
Other Study ID Numbers: CR015667, R076477SCH4035, PAL-TWN-MA3
Study First Received: April 12, 2012
Last Updated: April 12, 2012
Health Authority: Taiwan: Taiwan Food and Drug Administration

Keywords provided by Johnson & Johnson Taiwan Ltd:
Schizophrenia
Paliperidone Extended-Release (ER)

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 May 16, 2013