Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonathan M. Meyer, MD, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00338949
First received: June 16, 2006
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Metabolic Syndrome X
Insulin Resistance
Drug: Ziprasidone
Drug: Standard atypical antipsychotic drug
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Metabolic Syndrome in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Visceral fat mass [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Total adiposity [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body mass index [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Fasting lipids [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Total psychiatric hospital days [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: June 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone
Drug: Standard atypical antipsychotic drug
Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
Experimental: Switch
Participants who enter on risperidone or olanzapine and switch to ziprasidone
Drug: Ziprasidone
Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.

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 following outcomes will be assessed at study entry and Week 26: insulin sensitivity, using an intravenous glucose tolerance test; visceral fat mass, using a CT scan; and total adiposity, using a dexascan.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Currently receiving antipsychotic therapy with risperidone or olanzapine
  • Overweight

Exclusion Criteria:

  • Diagnosis of diabetes
  • Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to study entry
  • Refractory schizophrenia or schizoaffective disorder
  • Currently receiving therapy with clozapine
  • No stable residence and phone number for 90 days prior to study entry
  • Prior unsuccessful treatment with ziprasidone
  • Intolerance to ziprasidone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338949

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
Investigators
Principal Investigator: Jonathan M. Meyer, MD University of California, San Diego & VA San Diego Healthcare System
  More Information

Additional Information:
Publications:
Responsible Party: Jonathan M. Meyer, MD, Research Scientist, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00338949     History of Changes
Other Study ID Numbers: K23 MH074540, K23MH074540, DATR AK-TNET1
Study First Received: June 16, 2006
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Veterans Medical Research Foundation:
Ziprasidone
Olanzapine
Risperidone
Schizoaffective Disorder
Insulin Sensitivity
Visceral Adiposity
Metabolic Syndrome

Additional relevant MeSH terms:
Insulin Resistance
Schizophrenia
Metabolic Syndrome X
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Olanzapine
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014