Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will compare the effectiveness of antipsychotic medications for patients with
      schizophrenia or schizoaffective disorder for whom a medication change may be indicated
      because of an increased risk of cardiovascular disease.
    

Detailed description: 
      Metabolic abnormalities associated with cardiovascular morbidity and premature mortality are
      more common in patients with schizophrenia than in matched controls. Although there is some
      evidence that patients with schizophrenia have intrinsic abnormalities in lipid and
      carbohydrate metabolism, some antipsychotics (i.e., clozapine, olanzapine, quetiapine, and
      risperidone) are associated with increased rates of metabolic abnormalities that predispose
      patients to cardiovascular disease.

      This is an investigator-initiated clinical trial that will be conducted at 30 research sites
      that are a part of the NIMH Schizophrenia Trials Network.

      The aims of the study are to (1) determine the relative effects of switching to aripiprazole,
      versus continued treatment with olanzapine, quetiapine, or risperidone, on metabolic
      parameters associated with cardiovascular disease, and (2) to determine the effects of
      switching to aripiprazole versus continued treatment with olanzapine, quetiapine, or
      risperidone on the clinical stability of schizophrenic illness.

      This study design is a multi-site, single-blind (rater) randomized controlled trial of 300
      patients with schizophrenia or schizoaffective disorder comparing treatment with the
      following medications: olanzapine, quetiapine, risperidone, and aripiprazole. The study will
      enroll patients with schizophrenia or schizoaffective disorder for whom a medication change
      may be indicated because of an increased risk of cardiovascular disease in spite of adequate
      control of symptoms on their current antipsychotic medication. Patients who are taking
      olanzapine, quetiapine, or risperidone and who have a body-mass index (BMI) greater than or
      equal to 27 and non-HDL cholesterol greater than or equal to 130 mg/dl will be eligible (if
      non-HDL is between 130-139mg/dL, LDL cholesterol must be greater than 100mg/dL). All
      treatments will be open label. Raters will be blinded to treatment assignment. Patients will
      be followed for up to 6 months.
    

Intervention name(s): Risperidone; Olanzapine; Quetiapine; Aripiprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study; Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study; Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study; Switching medication to aripiprazole for schizophrenia for up to 6 months in study
Other intervention name(s): Risperdal; Zyprexa; Seroquel; Abilify
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment