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

NCT00827840 | Completed Phase 4 DMC

• 1 other identifier: PAL-KOR-9006
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Neurocognitive function

  12 weeks

Secondary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  monthly

Study Arms (2)

1. Paliperidone ER

EXPERIMENTAL

New antipsychotics

Drug: Paliperidone ER

2 Risperidone

ACTIVE COMPARATOR

Drug: Risperidone

Interventions

Paliperidone ER DRUG

3mg to 12mg of Paliperidone ER once a day

Also known as: Invega

1. Paliperidone ER

Risperidone DRUG

1 to 6 mg of risperidone once or twice a day

Also known as: Risperdal

2 Risperidone

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Janssen Korea, Ltd., Korea: collaborator
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Dept. of Psychiatry, Chonnam National Univeristy Hospital

Gwangju, 501-757, South Korea

Location

Related Publications (1)

• Kim SW, Chung YC, Lee YH, Lee JH, Kim SY, Bae KY, Kim JM, Shin IS, Yoon JS. Paliperidone ER versus risperidone for neurocognitive function in patients with schizophrenia: a randomized, open-label, controlled trial. Int Clin Psychopharmacol. 2012 Sep;27(5):267-74. doi: 10.1097/YIC.0b013e328356acad.

  PMID: 22809972 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pyrimidinones

Study Officials

• Jin-Sang Yoon, Professor

  Dept. of Psychiatry, Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: November 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 23, 2011

Record last verified: 2011-12

Locations

KR (1)