Clinical trial NCT00269919: An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia
Official title: Effect on Efficacy, Safety and Quality of Life by Long-Term Treatment of Long-Acting Risperidone Microspheres in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Risperidone
Risperidal Consta
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2005-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description: This is an open-label (all people know the identity of the intervention) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants with schizophrenia. Participants will be treated with intramuscular (into a muscle) injections of either 25 milligram (mg) or 37.5 mg or 50 mg of risperidone twice weekly, every 2 weeks for 2 years. The total duration of study will be 2 years. The efficacy of participants will primarily be evaluated by total Positive and Negative Syndrome Scale (PANSS) score. Participants' quality of life and safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients)
* Participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication
* Participants who have signed informed consent form Exclusion Criteria:
* Participants who have never received any previous antipsychotic treatment
* Participants who have received clozapine during the last 3 months
* Participants with a serious unstable medical condition, including laboratory abnormalities
* Participants with a history of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
* Female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception

Primary outcomes:
measure: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96
timeFrame: Baseline and Week 96
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96
timeFrame: Baseline and Week 96
measure: Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96
timeFrame: Baseline and Week 96
measure: Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96
timeFrame: Baseline and Week 96
measure: Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
timeFrame: Baseline and Week 96
measure: Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96
timeFrame: Baseline and Week 96
measure: Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
timeFrame: Baseline and Week 96
measure: Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96
timeFrame: Baseline and Week 96
measure: Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96
timeFrame: Baseline and Week 96
measure: Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96
timeFrame: Baseline and Week 96
measure: Change From Baseline in NCFT: TMT-Error at Week 96
timeFrame: Baseline and Week 96
measure: Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score
timeFrame: Baseline and Week 96
measure: Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96
timeFrame: Baseline and Week 96
measure: Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score
timeFrame: Baseline and Week 96
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: