Database Registry for Neural Network Biomarkers in Psychosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUniversity of Texas Southwestern Medical Center
About this trial
Several observations have been made with magnetic resonance imaging (MRI) that characterize brain connections and brain function in individuals with schizophrenia and other mental disorders. For example, research investigating schizophrenia focuses on the dysfunction of connections within and between the medial temporal lobe and the prefrontal cortex as well as other pertinent brain regions. This database registry will allow for the collection of clinical interview data, behavioral data, blood, magnetic resonance imaging (MRI) data, and functional magnetic resonance imaging (fMRI) data on individuals with and without mental disorders to better understand how connections in the brain and various brain regions function differently while volunteers perform various cognitive tasks. This is an observational study that is being conducted to collect data and place it in a registry for current and future investigational questions related to imaging in mental disorders.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of Schizophrenia or Schizoaffective disorder
Competent to give informed consent
All races and ethnicities
Eyesight corrected to 20-40 or better
Disqualifiers
Diagnosis of an organic brain disease
Diagnosis of DSM-IV-TR alcohol or substance abuse within the last month or DSM-IV-TR alcohol or substance dependence within the last three months
Serious, unstable medical illness
History of serious head injury
Trial population
Individuals who have been diagnosed with the following disorders will be enrolled in this study: Schizophrenia and Schizoaffective disorder.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Patient volunteers
Group B: Healthy volunteers
Trial outcomes
Primary outcomes
1
Differences in hippocampal subfield activation between people with schizophrenia (or schizoaffective disorder) and healthy volunteers
This study will investigate the alterations in the medial temporal lobe, specifically the differences in hippocampal subfield activation, between patients with psychosis (Schizophrenia and Schizoaffective disorder), their relatives and normal volunteers. We hypothesize that there will be an increase in perfusion and a decrease in subfield activation in the people with psychosis.
Time frame
Participants will be assessed over the course of 4-6 weeks, until all study procedures are completeSecondary outcomes
1
Differences in glutamate neurotransmitters and glutamatergic function between people with schizophrenia (or schizoaffective disorder) and with healthy volunteers
We aim to measure glutamate-related neurochemical profiles in schizophrenia using proton magnetic resonance spectroscopy (MRS) 7T. We will measure several brain metabolites, including glutamate, glutamine, GABA, glycine, N-acetylaspartyl-glutamate, glutathione, and myo-inositol, in addition to other major signals in brain MRS (i.e., N-acetylaspartate, creatine and choline), in anterior cingulate cortex (ACC) and dorsolateral prefrontal cortex (DLPFC) in volunteers with schizophrenia (SZ) and normal volunteers (NV).
Time frame
Participants will be assessed over the course of 4-6 weeks, until all study procedures are completeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov