A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol and Placebo in Patients With Chronic 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 evaluate the effectiveness and safety of different doses of
      risperidone (an antipsychotic medication) compared with placebo and with a fixed 20 mg/day
      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 four dosages of risperidone (2, 6, 10 or 16
      mg/day) compared with placebo and with a fixed 20 mg/day dose of a standard antipsychotic,
      haloperidol in patients with chronic schizophrenia who are in-patients at the beginning of
      the study.

      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, followed by 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 percentage of patients showing clinical improvement (reduction of
      >=20% from baseline) on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
      and the total PANSS score, from baseline to 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,
      and urinalysis), 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 is
      more effective than placebo, as measured by clinical improvement on PANSS and the average
      total score for PANSS, in patients with chronic schizophrenia. Risperidone tablets, taken
      orally, starting with 1 mg twice daily, gradually increasing dose in Week 1 (except for 1 mg
      twice daily group), then 1, 3, 5, or 8 mg twice daily, continuing for 7 weeks. Haloperidol
      tablets, starting 1 mg twice daily and increasing to 10 mg twice daily (Week 1), continuing
      10 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 disorder; risperidone; antipsychotic agents