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Diabetes in Neuropsychiatric Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Kirkpatrick, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00446992
First received: March 12, 2007
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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
Schizophrenia
Drug: Olanzapine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Fasting Glucose [ Time Frame: Baseline and 4 week intervals ] [ Designated as safety issue: No ]
  • Fasting Insulin [ Time Frame: Baseline and 4 week intervals ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: Baseline and 4 week intervals ] [ Designated as safety issue: No ]
  • IL-6 [ Time Frame: Baseline and 4 week intervals ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: Baseline and 4 week intervals ] [ Designated as safety issue: No ]
  • Cholesterol Total [ Time Frame: Baseline and 4 week intervals ] [ Designated as safety issue: No ]
  • HDL [ Time Frame: Baseline and 4 week intervals ] [ Designated as safety issue: No ]
  • LDL [ Time Frame: Baseline and 4 week intervals ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446992

Locations
Spain
Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170
Barcelona, Spain, 08036
Sponsors and Collaborators
Investigators
Principal Investigator: Brian Kirkpatrick, M.D. Vice Chair of Psychiatry MCG
  More Information

Publications:
Responsible Party: Brian Kirkpatrick, Professor, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Schizophrenia
Schizoaffective
psychosis
olanzapine

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014