The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

Schizophrenia Clinical Trial

Official title:

The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166098
• Other study ID #: 15-00754
• Status: Completed
• Start date: July 5, 2016
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a single center study that uses both between-group comparisons and correlational analyses to establish biomarkers of dysmyelination and cognitive impairment in Psychotic Spectrum Disorders using imaging and neuropsychological assays.The study will provide non-invasive biomarkers of cognitive dysfunction in Psychotic Spectrum Disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

Patients:

• current DSM-5-defined diagnosis of a schizophrenia or bipolar disorder. A best estimate diagnostic approach will be utilized in which information from the Diagnostic Interview for Genetic Studies (DIGS) is supplemented by information from family informants, psychiatrists, and medical records to generate a diagnosis as needed
• no alcohol or substance abuse during the last 6 month
• no current substance-induced psychotic disorder or a psychotic disorder due to a general medical condition determined by DSM-5 criteria
• ages 18 to 30 years old;
• any race
• competent and willing to sign informed consent
• within 5 years from the disease onset.

Siblings:

• have the same biological parents as their PSD sibling
• any race
• no current or past history of psychotropic medication usage
• no alcohol or substance abuse during the last 6 months
• competent and willing to sign informed consent;
• ages 18 to 30 years old.

Healthy controls:

• matched for age to PSD patients
• no current or past history of psychotropic medication usage
• no prodromal symptoms and no family history of PSD
• no alcohol or substance abuse during the last 6 months
• competent and willing to sign informed consent.
• all attempts will be made to recruit controls with similar parental SES as patients. However, given that PSD are both a neurodevelopmental and familial disorder, exact matching for educational level or IQ may neither be possible nor desirable. have the same biological parents as their PSD sibling
• any race
• no current or past history of psychotropic medication usage
• no alcohol or substance abuse during the last 6 months
• competent and willing to sign informed consent;
• ages 18 to 30 years old.

Exclusion Criteria:

• a serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain, 2) organic brain disorder, mental retardation, or significant medical illness;
• significant risk of suicidal or homicidal behavior;
• must not have met DSM-5 criteria for current alcohol or drug dependence in the last 6 months;
• contraindications to MRI scanning (i.e., metal implants, pacemakers, pregnancy, etc.);
• documented loss of consciousness (LOC) for longer than 30 minutes or LOC with any neurological sequelae.

Related Conditions & MeSH terms

• Bipolar Disorder
• Cognitive Dysfunction
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Diagnostic Test:
• Cognitive Function Assessments
The NIMH-Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) is a consensus battery that is considered state-of-the art in the evaluation of cognitive skills for schizophrenia research.(Burton et al., 2013, Harvey, 2014) The complete cognitive battery takes about one hour to administer, and is comprised of 10 subtests measuring seven essential domains of function, with very good reliability and validity.(Nuechterlein 2008, August et al., 2012) The MATRICS subtests have been incorporated into the cognitive battery described below, with supplementary subtests included where indicated within each domain.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DKI(metrics RDextra, faxon, and ADextra) Metrics	To compare DKI metrics (faxon, RDextra, and ADextra) in patients with SZ or BP, their unaffected siblings (SIB), and healthy comparison control (HC) subjects	6 Years
Primary	Magnetic Resonance Spectroscopy will be employed to obtain quantitative metrics of choline (Cho)	Choline Concentration (1H-MRS)	1 Hour