Back to resultsDiabetes in Neuropsychiatric Disorders
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective, psychosis, olanzapine
Eligibility 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)
Sites / Locations
- Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Trial Group
Arm Description
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Outcomes
Primary Outcome Measures
Body Mass Index
Fasting Glucose
Fasting Insulin
Hemoglobin A1c
IL-6
Triglycerides
Cholesterol Total
HDL
LDL
Secondary Outcome Measures
Full Information
NCT ID
NCT00446992
First Posted
March 12, 2007
Last Updated
November 6, 2014
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00446992
Brief Title
Diabetes in Neuropsychiatric Disorders
Official Title
Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Schizoaffective, psychosis, olanzapine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Trial Group
Arm Type
Experimental
Arm Description
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa, Zydis, Relprevv
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
Baseline and 4 week intervals
Title
Fasting Glucose
Time Frame
Baseline and 4 week intervals
Title
Fasting Insulin
Time Frame
Baseline and 4 week intervals
Title
Hemoglobin A1c
Time Frame
Baseline and 4 week intervals
Title
IL-6
Time Frame
Baseline and 4 week intervals
Title
Triglycerides
Time Frame
Baseline and 4 week intervals
Title
Cholesterol Total
Time Frame
Baseline and 4 week intervals
Title
HDL
Time Frame
Baseline and 4 week intervals
Title
LDL
Time Frame
Baseline and 4 week intervals
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Kirkpatrick, M.D.
Organizational Affiliation
Vice Chair of Psychiatry MCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
21346617
Citation
Fernandez-Egea E, Miller B, Garcia-Rizo C, Bernardo M, Kirkpatrick B. Metabolic effects of olanzapine in patients with newly diagnosed psychosis. J Clin Psychopharmacol. 2011 Apr;31(2):154-9. doi: 10.1097/JCP.0b013e31820fcea3.
Results Reference
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Diabetes in Neuropsychiatric Disorders
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