Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Janssen Korea, Ltd., Korea
Ministry of Health, Republic of Korea
Information provided by (Responsible Party):
Jin-Sang Yoon, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT00827840
First received: January 22, 2009
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia.

Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone ER
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • Neurocognitive function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: November 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Paliperidone ER
New antipsychotics
Drug: Paliperidone ER
3mg to 12mg of Paliperidone ER once a day
Other Name: Invega
Active Comparator: 2 Risperidone Drug: Risperidone
1 to 6 mg of risperidone once or twice a day
Other Name: Risperdal

Detailed Description:

This is a 12-week, randomized, parallel-group, open labeled, flexible-dose study. The patients will be randomized to the risperidone-continuation group in which they continue to receive risperidone, or to the paliperidone-switch group in which they are switched from risperidone to paliperidone. In the paliperidone-switch group, risperidone will be tapered off during the first 4 weeks of the study, while paliperidone is titrated simultaneously. The doses of both drugs will be adjusted according to the clinical judgment of each research psychiatrist, within 6 mg/day of risperidone and 12 mg/day of paliperidone.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed as schizophrenia by DSM-IV-TR criteria both in inpatients
  • Patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment.
  • Patients with ability to complete various questionnaires.
  • Patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form

Exclusion Criteria:

  • Active psychotic symptoms, including severe behavioral disturbance
  • Relevant history of or current presence of any significant or unstable medical disease
  • A woman who is pregnant, breast-feeding or planning to become pregnant during the study period
  • Patients with the history of serious allergy or multiple adverse drug reactions
  • Patients with the history of taking paliperidone ER within 60 days
  • Patients with history of taking clozapine within 60 days
  • Patients who require the treatment of other medications influencing CNS, except permitted concomitant drugs in advance
  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: NCT00827840

Locations
Korea, Republic of
Dept. of Psychiatry, Chonnam National Univeristy Hospital
Gwangju, Korea, Republic of, 501-757
Sponsors and Collaborators
Chonnam National University Hospital
Janssen Korea, Ltd., Korea
Ministry of Health, Republic of Korea
Investigators
Principal Investigator: Jin-Sang Yoon, Professor Dept. of Psychiatry, Chonnam National University Hospital
  More Information

No publications provided by Chonnam National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin-Sang Yoon, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT00827840     History of Changes
Other Study ID Numbers: PAL-KOR-9006
Study First Received: January 22, 2009
Last Updated: December 22, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
9-hydroxy-risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on October 02, 2014