Clinical trial NCT00827840: Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia
Official title: Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Janssen Korea, Ltd., Korea
name: Ministry of Health, Republic of Korea
First posted: 2009-01-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Neurocognitive function
timeFrame: 12 weeks
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: monthly
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Dept. of Psychiatry, Chonnam National Univeristy Hospital
Study officials:
affiliation: Dept. of Psychiatry, Chonnam National University Hospital
name: Jin-Sang Yoon, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.