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Diabetes in Neuropsychiatric Disorders

This study has been completed.
Information provided by (Responsible Party):
Brian Kirkpatrick, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier:
First received: March 12, 2007
Last updated: November 6, 2014
Last verified: November 2014

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 Intervention Phase
Drug: Olanzapine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis

Resource links provided by NLM:

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: Baseline and 4 week intervals ]
  • Fasting Glucose [ Time Frame: Baseline and 4 week intervals ]
  • Fasting Insulin [ Time Frame: Baseline and 4 week intervals ]
  • Hemoglobin A1c [ Time Frame: Baseline and 4 week intervals ]
  • IL-6 [ Time Frame: Baseline and 4 week intervals ]
  • Triglycerides [ Time Frame: Baseline and 4 week intervals ]
  • Cholesterol Total [ Time Frame: Baseline and 4 week intervals ]
  • HDL [ Time Frame: Baseline and 4 week intervals ]
  • LDL [ Time Frame: Baseline and 4 week intervals ]

Enrollment: 30
Study Start Date: April 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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)
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Please refer to this study by its identifier: 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
  More Information

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
Study First Received: March 12, 2007
Results First Received: October 22, 2014
Last Updated: November 6, 2014

Keywords provided by 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 processed this record on April 26, 2017