Diabetes in Neuropsychiatric Disorders

November 6, 2014 updated by: Brian Kirkpatrick, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Zyprexa, Zydis, Relprevv

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Brian Kirkpatrick, M.D., Vice Chair of Psychiatry MCG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (ESTIMATE)

March 13, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 6, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK69265
  • HAC File#: 05-12-141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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