Phase 4 N=40 Treatment

An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia

Schizophrenia · Schizoaffective Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00269919 ↗

Enrolled (actual)

Serious AEs

15.4%

Results posted

Aug 2013

Primary outcome: Primary: Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96 — 73.00; 18.24 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Risperidone Long-Acting Injectable (RLAI) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Janssen Korea, Ltd., Korea
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96	73.00; 18.24	—
SECONDARY Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96	4.62; -0.89	—
SECONDARY Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96	44.32; 8.86	—
SECONDARY Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96	71.22; 2.06	—
SECONDARY Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96	11.39; 1.36; 12.28; 1.18; 10.00; 1.18	—
SECONDARY Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96	10.25; 0.00	—
SECONDARY Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96	9.81; 2.30; 8.71; 1.60; 7.96; 2.40	—
SECONDARY Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96	15.11; -0.10; 8.75; 2.20; 9.18; 1.70	—
SECONDARY Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96	93.71; 10.70	—
SECONDARY Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96	39.83; -3.18; 96.03; -16.0	—
SECONDARY Change From Baseline in NCFT: TMT-Error at Week 96	0.11; 0.00; 0.68; -1.11	—
SECONDARY Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score	101.32; 76.54	—
SECONDARY Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96	-0.22; 0.28	—
SECONDARY Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score	4.13; 2.50	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00269919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.