A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol in Patients With Chronic Schizophrenia
Condition: Schizophrenia; Psychotic Disorder
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the effectiveness and safety of different doses of
      risperidone (an antipsychotic medication) compared with a fixed 10-mg dose of a standard
      antipsychotic, haloperidol, in patients with chronic schizophrenia.
    

Detailed description: 
      Chronic schizophrenia is a longer-term condition that is characterized by a lack of drive,
      underactivity and slowness, and social withdrawal. As with the acute form of schizophrenia,
      delusions and hallucinations are common. This is a randomized, double-blind, parallel-group
      study to evaluate the effectiveness and safety of five dosages of risperidone (1, 4, 8, 12,
      or 16 mg per day) compared with a fixed dose of a standard antipsychotic, haloperidol (10 mg
      per day) in patients with chronic schizophrenia. The study is composed of two phases: a
      1-week period, in which patients receive placebo and all current medication for schizophrenia
      treatment is stopped, and a double-blind treatment phase. The doses of study drug are
      increased progressively during the first week of the double blind period and then remain
      constant for the next 7 weeks. The primary measures of effectiveness are the percent of
      patients showing clinical improvement on the Positive and Negative Syndrome Scale for
      Schizophrenia (PANSS) and the average total PANSS score, from baseline to the end of
      double-blind treatment. 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, and hormone levels), plasma
      levels of risperidone, measurements of vital signs and body weight, physical examination and
      electrocardiogram (ECG) findings, neurological examinations, and the Extrapyramidal Symptoms
      Rating Scale (ESRS), a scale used to measure effects of antipsychotic medications on motor
      functions of the patient. The study hypothesis is that risperidone doses of 4, 8, 12, or 16
      mg/day are more effective than risperidone 10 mg/day, as measured by clinical improvement on
      PANSS and the average total score for PANSS, in patients with chronic schizophrenia.
      Risperidone oral tablets, twice-daily, starting with 1 or 2 mg/day, increasing gradually in
      Week 1 (except for 1 mg/day group), then 0.5, 2, 4, 6, or 8 mg twice daily for 7 weeks.
      Haloperidol oral tablets, twice-daily, starting with 2 mg/day, increasing to 5 mg twice daily
      in Week 1, then 5 mg twice daily for 7 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: chronic schizophrenia; psychotic disorders; risperidone; antipsychotic agents