Diabetes in Neuropsychiatric Disorders - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00446992

Purpose

The objective of this study is to determine if newly diagnosed schizophrenia patients have higher insulin resistance than the general population.

The hypothesis for this study is 2 fold. Drug-naive, newly diagnosed schizophrenia patients have higher insulin resistance than a control group matched on gender, age, body mass index, smoking, and substance abuse. Additionally 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
Schizophrenia

MedlinePlus related topics: Diabetes Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Diabetes in Neuropsychiatric Disorders

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

whole blood and DNA

Estimated Enrollment:	328
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2011

Detailed Description:

Study Aim 1 is a metabolic study of four groups of subjects: 1) patients newly diagnosed with schizophrenia, who have not previously received an antipsychotic medication, 2) patients newly diagnosed with a major depressive episode, who have not previously received an antidepressant medication, 3) patients newly diagnosed with adjustment disorder, who have not previously received an antipsychotic medication,, and 4) volunteers without a lifetime diagnosis of schizophrenia or major depressive disorder, or a current diagnosis of adjustment disorder. The hypothesis to be tested is that the patients with schizophrenia have increased insulin resistance compared to the control group. We anticipate that over five years, we will be able to enter approximately 82 subjects in each of the four groups.

Specific Aim 2 is an open-label treatment trial of olanzapine in psychotic subjects (with schizophrenia or another diagnosis) who participated in the metabolic study in Aim 1. We will test the hypothesis that an elevated baseline insulin resistance predicts a disproportionate increase in insulin resistance with subsequent olanzapine administration. We anticipate that over five years, we will be able to enter approximately 105 subjects.

As the diagnosis of schizophrenia cannot be established with confidence on first assessment, all psychotic subjects who consent will be enrolled in Study 1. However, our primary analysis of that study will be a comparison of subjects with a six-month follow-up diagnosis of schizophrenia to the other subject groups; that analysis will not include psychotic subjects with another diagnosis, such as schizoaffective disorder or psychosis not otherwise specified. In contrast, all psychotic subjects who are clinically appropriate for antipsychotic treatment will be eligible for inclusion in Study 2, as well as those with a follow-up diagnosis of schizophrenia, and both groups will be included in the analysis of the Aim 2 study.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

The study population will be derived from both a primary care clinic and the community.

Criteria

Inclusion Criteria for Study Aim 1:

age 18-60
Maximum cumulative (lifetime) antipsychotic and antidepressant exposure of one week, and no antipsychotic use in the previous 30 days
Psychosis group: patients newly diagnosed with psychosis, and have not previously received an antipsychotic or antidepressant medication
Depression group: Patients with a newly diagnosed major depressive episode, who have not previously received an antipsychotic or antidepressant medication
Adjustment disorder group: patients newly diagnosed with adjustment disorder, who have not previously received an antipsychotic or antidepressant medication
Control group: volunteers without a lifetime diagnosis of schizophrenia or major depressive disorder, or a current diagnosis of adjustment disorder, who have not previously received an antipsychotic or antidepressant medication

Exclusion Criteria For Study Aim 1:

Group 1: Major depressive episode or bipolar disorder
Group 2: Presence of psychotic symptoms
Group 3: Major depressive episode
Group 4: Axis I psychiatric disorder
History of diabetes or other serious medical or neurological condition
Taking any of the following: specific diuretics (HCTZ, furosemide, ethacrynic acid, metolazone, chlorthalidone), beta blockers, glucocorticoids, phenytoin, nicotinic acid, cyclosporine, pentamidine,narcotics
evidence of imminent danger to self or others, such as suicidal intent, or recent history of violence or threats of violence
substance abuse other than abuse of alcohol or marijuana (e.g., cocaine and opiate use would exclude the subject)

Inclusion Criteria For Study Aim 2:

Participation in the study Aim 1, "Diabetes in Neuropsychiatric Disorders."
A diagnosis of nonaffective psychosis, other than psychosis due to a general medical condition or substance-induced psychosis.
On clinical grounds, considered to be an appropriate subject for antipsychotic treatment.
Maximum cumulative (lifetime) antipsychotic exposure of four weeks, and no antipsychotic use in the previous one week.

Exclusion Criteria For Study Aim 2:

2-hour glucose concentration in the GTT > 200 mg/dl, or
fasting glucose > 110 mg/dl.

Contacts and Locations

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

Contacts

Contact: Linh D Nguyen, BS	706-721-0496	lnguyen@mail.mcg.edu
Contact: Edna M Stirewalt, BS	706-721-7968	estirewalt@mcg.edu

Locations

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

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Brian Kirkpatrick, M.D.

Vice Chair of Psychiatry MCG

More Information

Responsible Party:	Medical College of Georgia ( Brian Kirkpatrick, M.D., M.S.P.H. )
Study ID Numbers:	DK69265, HAC File#: 05-12-141
Study First Received:	March 12, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00446992
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

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Olanzapine

Diabetes Mellitus
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009