Diabetes in Neuropsychiatric Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00446992
First received: March 12, 2007
Last updated: February 1, 2011
Last verified: February 2011
  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

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

Resource links provided by NLM:


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

Biospecimen Retention:   Samples With DNA

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
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

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
Investigators
Principal Investigator: Brian Kirkpatrick, M.D. Vice Chair of Psychiatry MCG
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Kirkpatrick, M.D., M.S.P.H., Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00446992     History of Changes
Other Study ID Numbers: DK69265, HAC File#: 05-12-141
Study First Received: March 12, 2007
Last Updated: February 1, 2011
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

ClinicalTrials.gov processed this record on October 23, 2014