Diabetes in Neuropsychiatric Disorders
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Diabetes in Neuropsychiatric Disorders|
whole blood and DNA
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||April 2011|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446992
|Contact: Linh D Nguyen, BSfirstname.lastname@example.org|
|Contact: Edna M Stirewalt, BSemail@example.com|
|Unitat Hospitalitzacio - Servei de Psiquiatria G096, Hospital Clinic C/Villarroel, 170||Recruiting|
|Barcelona, Spain, 08036|
|Principal Investigator:||Brian Kirkpatrick, M.D.||Vice Chair of Psychiatry MCG|