A Study Comparing Three Strategies to Switch Patients With Schizophrenia or Schizoaffective Disorder to Risperidone After Unsuccessful Treatment With Olanzapine.
Condition: Schizoaffective Disorder; Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare three strategies for switching patients with
      schizophrenia or schizoaffective disorder to the atypical antipsychotic, risperdone, after
      they have been unsuccessfully treated with another atypical antipsychotic, olanzapine. In the
      second phase of this study, investigators will assess the effectiveness of behavioral therapy
      in reducing body weight in risperdone-treated patients who are overweight or have problems
      with diabetes or blood sugar.
    

Detailed description: 
      Data regarding the safety and effectiveness of different strategies for switching subjects
      with schizophrenia from one antipsychotic medication to another are very rare. Studies that
      have examined various switching designs, especially with regard to the newer atypical
      antipsychotic agents, suggest that either abrupt or gradual discontinuation does not
      inevitably lead to worsening of symptoms. This study is randomized (patients are assigned
      different treatments based on chance), open-label, with a parallel group design to assess the
      safety and effectiveness of each of three strategies of discontinuing olanzapine and starting
      risperidone. The first strategy is the discontinuation of olanzapine on the day risperidone
      is started. The second strategy involves a reduction in the dose of olanzapine to one half of
      the study entry dose on the day risperidone is started. The reduced dose of olanzapine is to
      be given for one week and then discontinued. In the third strategy, the dose of olanzapine
      remains unchanged for the first week, then is reduced by one half of the study entry dose,
      and at the end of the second week is discontinued. In all three strategies, patients take the
      same dose of risperidone: 1 mg by mouth twice a day for 3 days, then 2 mg twice a day for the
      next 4 days. Further increase or decrease of risperidone dose and/or changing to a single
      daily dose can be carried out at the end of the first week. Additionally, after 6 weeks of
      risperidone therapy, patients who are overweight or have problems with diabetes or blood
      sugar may enter a second phase of the study that examines weight loss. In this phase,
      patients are randomized to receive routine clinical care or training on weight management
      behavioral techniques while continuing to take risperidone for an additional 14 weeks. At the
      end of 14 weeks, total weight loss, changes in lipids, cholesterol and other laboratory
      measures will be compared between the two groups. The study hypothesis is that symptom
      improvement or worsening at week 14, as measured by total score on the Positive and Negative
      Syndrome Scale (PANSS), should not differ depending on the method of switching from
      olanzapine to risperidone. Safety evaluations incude collection of adverse events, clinical
      laboratory tests and assessment of vital signs.

      The patients will receive oral tablets of risperidone 1 to 2 milligram[mg] twice a day
      (higher or lower dose and/or changing to single daily dose allowed at end of the first week)
      for the duration of 6 weeks in phase 1, and then for 14 more weeks in phase 2 of the study.
      Olanzapine: none; or half of the study entry dose for 1 week; or study entry dose for 1 week,
      then half of the study entry dose for an additional week.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss; behavioral therapy; risperidone; switching antipsychotics; schizoaffective disorder; Risperdal; schizophrenia; olanzapine; Zyprexa