A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in the Treatment of Patients With Schizophrenia
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare the effectiveness and safety of a long-acting
      injectable formulation of risperidone (an antipsychotic medication) versus placebo for the
      treatment of the symptoms of schizophrenia over a 12-week period.
    

Detailed description: 
      Schizophrenia is a severe mental illness that causes changes in a person's perception,
      thoughts, and behaviour. In schizophrenics, the most common symptoms are positive symptoms
      (delusions and hallucinations), negative symptoms (avoiding social situations, lack of
      feeling or expression), and disorganized symptoms (confusion in thinking and speech). Because
      of the serious nature of these diseases, it is important that patients with schizophrenia
      take their antipsychotic medication regularly. Long-acting injectable forms of antipsychotic
      drugs may eliminate the need for daily oral medication and increase a patient's compliance in
      taking their medication as prescribed by their physician. This is a randomized, double-blind,
      parallel-group, placebo-controlled study comparing the effectiveness and safety of an
      injectable formulation of risperidone (coated microspheres) to placebo in patients with
      schizophrenia. The study is composed of two periods: a 1-week run-in period (patients
      discontinue other antipsychotic drugs and receive oral risperidone, up to 4 mg/day) and a 12
      week double-blind period during which subjects are randomized to receive bi-weekly injections
      of placebo or risperidone long-acting injectable formulation (25, 50, or 75 mg). During the
      first 3 weeks of double-blind treatment, patients will receive supplemental daily oral doses
      of placebo or risperidone tablets. The primary measure of effectiveness is the change from
      baseline in the total score for the Positive and Negative Syndrome Scale for Schizophrenia
      (PANSS). The PANSS is a rating scale that measures the symptoms of schizophrenia. Safety
      evaluations include the incidence of adverse events, results of clinical laboratory tests
      (hematology, biochemistry, urinalysis), measurements of vital signs and body weight, physical
      examination and electrocardiogram (ECG) findings, clinical examination of the injection area
      (buttocks), and the Extrapyramidal Symptoms Rating Scale (ESRS), a scale used to measure
      effects of antipsychotic medications on motor functions of the patient. Additional testing
      conducted includes the Clinical Global Impressions (CGI), a rating system used to evaluate
      the overall and severity of clinical change in a patient with various diseases affecting the
      brain, and the SF-36 Health Survey, a questionnaire the patient fills out that is extensively
      used to rate a patient's quality of life. The study hypothesis is that the injectable form of
      risperidone will be more effective than placebo, as measured by the change from baseline in
      the total PANSS score, in patients with schizophrenia. 1-week run-in period: risperidone oral
      tablets, up to 4 mg/day. During the first 3 weeks of double-blind period: risperidone oral
      tablets, 2, 4, or 6 mg/day or placebo tablets. Day 1 of double-blind period and every 2 weeks
      thereafter: risperidone intramuscular injection (25, 50, or 75 mg) or placebo injection for
      12 weeks.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorder; psychotic disorder; risperidone; long-acting injectable; intramuscular injection; antipsychotic agents