Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes
Condition: Schizophrenia; Metabolic Syndrome X; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a
      standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess
      abdominal fat storage in people with schizophrenia who are at risk for diabetes.
    

Detailed description: 
      People with schizophrenia often lead more sedentary lifestyles than people without the
      disease, and they are frequently treated with antipsychotic medications that cause weight
      gain. Combined, these factors produce an increased risk for metabolic syndrome, which can
      lead to heart disease and type 2 diabetes. Characteristics of metabolic syndrome include
      carrying excess weight around the abdominal region; high blood pressure; high blood sugar
      levels; high levels of fat in the blood; and low levels of HDL cholesterol. Recent studies
      have shown that certain atypical antipsychotic drugs are relatively weight-neutral. Switching
      from a drug that promotes weight gain to a weight-neutral medication, such as ziprasidone,
      may result in significant weight loss. There is insufficient evidence, however, demonstrating
      the extent of improvement in insulin sensitivity after switching medications. This study will
      evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical
      antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage
      in people with schizophrenia who are at risk for diabetes.

      Participants in this open label study will currently be undergoing treatment with risperidone
      or olanzapine at the time of study entry. Upon study entry, they will be randomly assigned to
      either switch to ziprasidone treatment or remain on their current medications. Both groups
      will be treated for 26 weeks. Participants will report to the study site for evaluations
      biweekly until week 10 and then monthly for the duration of the study. The primary outcomes
      at Week 26 will be: change from baseline in insulin sensitivity, using an intravenous glucose
      tolerance test; change from baseline in ivisceral fat mass, using a CT scan.
    

Intervention name(s): Switch; Control
Intervention type(s): Drug; Drug
Intervention description(s): Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.; Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
Other intervention name(s): ziprasidone; risperidone; olanzapine
Intervention MeSH terms: Olanzapine; Risperidone; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ziprasidone; Olanzapine; Risperidone; Schizoaffective Disorder; Insulin Sensitivity; Visceral Adiposity; Metabolic Syndrome