Diabetes in Neuropsychiatric Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446992
Recruitment Status : Completed
First Posted : March 13, 2007
Results First Posted : November 6, 2014
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
Brian Kirkpatrick, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:

The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis.

We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Olanzapine Phase 1 Phase 2

Detailed Description:
Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis
Study Start Date : April 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Open Trial Group
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Drug: Olanzapine
16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
Other Name: Zyprexa, Zydis, Relprevv

Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: Baseline and 4 week intervals ]
  2. Fasting Glucose [ Time Frame: Baseline and 4 week intervals ]
  3. Fasting Insulin [ Time Frame: Baseline and 4 week intervals ]
  4. Hemoglobin A1c [ Time Frame: Baseline and 4 week intervals ]
  5. IL-6 [ Time Frame: Baseline and 4 week intervals ]
  6. Triglycerides [ Time Frame: Baseline and 4 week intervals ]
  7. Cholesterol Total [ Time Frame: Baseline and 4 week intervals ]
  8. HDL [ Time Frame: Baseline and 4 week intervals ]
  9. LDL [ Time Frame: Baseline and 4 week intervals ]

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Age 18-64
  • Maximum cumulative (lifetime) antipsychotic exposure of one week, and no antipsychotic use in the previous 30 days before enrolling in the study
  • No history of diabetes or other serious medical or neurological condition associated with glucose intolerance or insulin resistance (eg, Cushing disease),
  • Not taking a medication associated with insulin resistance (eg, hydrochlorothiazide, furosemide, ethacrynic acid, metolazone, chlorthalidone), beta blockers, glucocorticoids, phenytoin, nicotinic acid, cyclosporine, pentamidine, or narcotics)
  • No history of cocaine use in the previous 30 days, and
  • No laboratory evidence of diabetes at baseline (fasting glucose <126 mg/dL or 2-hour glucose <200 mg/dL on a glucose tolerance test)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446992

Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170
Barcelona, Spain, 08036
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Brian Kirkpatrick, M.D. Vice Chair of Psychiatry MCG

Responsible Party: Brian Kirkpatrick, Professor, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT00446992     History of Changes
Other Study ID Numbers: DK69265
HAC File#: 05-12-141
First Posted: March 13, 2007    Key Record Dates
Results First Posted: November 6, 2014
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Brian Kirkpatrick, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents