Official Title: “A Randomized, Open-label, Active-controlled Study to Evaluate Social Functioning of Long Acting Injectable Risperidone and Oral Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder”

The purpose of the study is to evaluate the effect long-acting injectable risperidone and oral risperidone treatment has on the social functioning of patients with schizophrenia or schizoaffective disorder.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2010

This is a randomized (treatment group assigned by chance), open-label (all involved people know the identity of the study drug), active-controlled study to evaluate the social functioning of long-acting injectable risperidone and oral risperidone in the treatment of patients with schizophrenia or schizoaffective disorders. The primary objective of this study is to evaluate the improvement in social functions among patients taking long-acting injectable risperidone, compared with oral risperidone, after treatment respectively for 12 months. The secondary objectives of this study are to evaluate the efficacy and safety of the compound and to evaluate drop out rates, cognitive function, improvement in overall quality of life and health economic data after treatment with long-acting injectable risperidone and oral risperidone. The study drug will be administered for 52 weeks as flexible dosage (dose range is according to the local label and adjusted by clinician discretion) and a total of 11 assessment occasions will be conducted, including the screening phase, per patient. The patient may be withdrawn from the trial for any medical reason at the sole discretion of the investigator. Antipsychotic drugs administered to the patients will be limited to long-acting injectable risperidone and oral risperidone. The supplement of oral risperidone for the first 3 - 4 weeks during the administration of long-acting injectable risperidone is also required. The aim is to examine changes in social and occupational functioning after 12 months of treatment among each group, using the PSP (personal and social performance scale) for measurement. Primary efficacy measure is PSP and secondary efficacy measures are PANSS (positive and negative syndrome scale), CGI-S (clinical global impression-severity), SFS (social functioning scale), Emotional & Social Functioning Scale, Neurocognitive Function Test; CPT(continuous performance task), COWAT(controlled word association task), K-WAIS (Korean-Wechsler adult intelligence scale) and TOM(theory of mind) , HE (health-economic) Questionnaire, PWI (psychosocial well-being index), DAI (drug attitude inventory), SUMD (scale to assess unawareness of mental disorder), GAF (global assessment of functioning). Safety evaluations are AIMS (abnormal involuntary movement scale), BARS (barnes akathisia rating scale), SAS (simpson-angus rating scale) and adverse events/serious adverse events reporting. The study includes run-in period during minimum 2 weeks for stabilizing to risperidone. In this period patients take oral risperidone. Patients who randomized each treatment group in baseline will visit every 2 weeks and take long-acting injectable risperidone or oral risperidone for treatment period of 52 weeks.

Intervention(s) in this Clinical Trial

• Drug: Long-acting injectable risperidone and oral risperidone

Primary Measures

• The primary outcome measure is PSP scale to evaluate the improvement in social functions among patients taking long-acting injectable risperidone compared with oral risperidone after treatment respectively for 12 months.
  • Time Frame: The primary outcome measure is assessed at baseline, 6-month and 12-month or early withdrawal.
    Safety Issue?: No

Secondary Measures

• To evaluate the efficacy and safety by comparing the scores of the following assessment tools: PANSS, CGI-S, AIMS, SAS, BARS and AE reports
  • Time Frame: baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month, 9-month and 12-month or early withdrawal
    Safety Issue?: No
• To obtain pharmaco economic data using the health economic questionnaire
  • Time Frame: baseline, 6-month, 12-month or early withdrawal
    Safety Issue?: No
• To evaluate the cognitive functions and improvements in overall quality of life by comparing the scores of the following assessment tools: neurocognitive function battery, GAF, SUMD, SFS, PWI, DAI and emotional social function scale
  • Time Frame: baseline, 6-month, 12-month or early withdrawal
    Safety Issue?: No

Inclusion Criteria:

• Schizophrenic or schizoaffective patient (hospitalized or outpatient) who require long-term antipsychotic drug therapy
• A signed informed consent document, indicating that the patient understands the purposes of, and procedures relating to, the study, and are willing to participate in it
• Patients whose informed consent forms were signed by either the patient, their caregivers, or legal representative
• Patient with more than 71 points in a premorbid GAF score, (as determined as a result of their medical history), as evaluated at the time of screening
• Patient who did not exhibit clinically significant abnormalities in the biochemical test and the electrocardiogram (ECG)
• Patient who intends to be compliant with, will be available and willing to fulfill the requirements of the trial

Exclusion Criteria:

• Patient administered clozapine within the 3 months previous to the commencement of the trial
• Patient with mental retardation (with an IQ less than 70 at screening)
• Patient with a history of serious alcohol or drug addiction over the 6 months previous to the commencement of the trial
• Patient with serious diseases, (cardiovascular, respiratory, neurological - including the suffering of seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunological, or other systemic diseases), which include abnormal values recently and/or currently clinically relevant
• Patient with a history of Neuroleptic Malignancy Syndrome and Tardive Dyskinesia
• Patient hyper-responsive or allergic to risperidone, or who are completely unresponsive to risperidone
• Female patient who is pregnant or breast-feeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen Korea, Ltd., Korea

Overall Clinical Trial Officials and Contacts

Janssen Korea, Ltd. Clinical Trial Study Director Janssen Korea, Ltd.  

Overall Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email  info1@veritasmedicine.com

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00992407

Study ID Number: CR015841

ClinicalTrials.gov Identifier: NCT00992407

Health Authority: Korea: Food and Drug Administration