A Comparison of Risperidone With Haloperidol in Patients With Schizophrenia and Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the time to relapse in patients with schizophrenia and
      schizoaffective disorders receiving risperidone or haloperidol (antipsychotic medications)
      for at least 1 year.
    

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).
      Schizoaffective disorder is different from schizophrenia, although it may be misdiagnosed as
      this illness. Schizoaffective disorder is a mental illness distinguished by a combination of
      a thought disorder (abnormal thinking or psychotic symptoms such as hallucinations or
      delusions) and a mood disorder (clinical depression or manic component). Manic symptoms
      include, but are not limited to an overinflated self esteem, increased physical agitation,
      excessively poor judgment, being easily distracted, and an increased irritability and energy
      level. This is a randomized, double-blind, parallel-group, controlled study comparing the
      time to relapse and the incidence of relapse in patients with schizophrenia and
      schizoaffective disorder being treated with risperidone or haloperidol. The long-term safety
      and effectiveness of risperidone and haloperidol are also compared. The study is composed of
      two phases: a 1-week baseline period and a double-blind treatment period. During the baseline
      period, the doses of risperidone and haloperidol are gradually increased to 4 mg/day for
      risperidone and 10 mg/day for haloperidol. During the first 4 weeks of double-blind
      treatment, dosage adjustments can be made in the range of 2 - 8 mg/day for risperidone and 5
      - 20 mg/day for haloperidol, based on clinical evaluations of the patient. The double-blind
      treatment continues at that dose until the last patient entering the study completes 1 year
      of treatment or for a maximum of 112 weeks. The primary measure of effectiveness is the time
      to relapse, which is defined using six criteria that indicate the patient's illness is no
      longer under control (for example, psychiatric hospitalization). Additional efficacy testing
      conducted includes the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), a
      rating scale that measures the symptoms of schizophrenia; 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 Quality of Life Interview (QOLI),
      a global measure of satisfaction with life. 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, 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 will be more effective in delaying relapse than haloperidol in patients
      with schizophrenia and schizoaffective disorder. Risperidone tablets, taken orally, starting
      at 1 mg/day; increasing to 4 mg/day (Week 1). Haloperidol tablets, taken orally, starting at
      2 mg/day; increasing to 10 mg/day (Week 1). After Week 1, dosage may be adjusted (2 - 8
      mg/day risperidone; 5 - 20 mg/day haloperidol). Treatment duration >=52 weeks.
    

Intervention name(s): risperidone; haloperidol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Haloperidol; Risperidone; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia, Psychotic Disorders; Haloperidol; Risperidone; Schizoaffective disorder