Schizophrenia Clinical Trial
Official title:
Risperidone Versus Haloperidol Versus Placebo in the Treatment of Chronic Schizophrenia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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