ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00827840
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : December 23, 2011
Sponsor:
Collaborators:
Janssen Korea, Ltd., Korea
Ministry of Health, Republic of Korea
Information provided by (Responsible Party):
Jin-Sang Yoon, Chonnam National University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Schizophrenia Drug: Paliperidone ER Drug: Risperidone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial
Study Start Date : November 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Neurocognitive function [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: monthly ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Paliperidone Palmitate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists