The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

Completed

• Conditions: Schizophrenia; Bipolar Disorder
• Interventions: Diagnostic Test: Cognitive Function Assessments

• Registration Number: NCT03166098
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-05
• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-24
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnosis of Bipolar Disorder	Cognitive Function Assessments	-
Diagnosis of Schizophrenia	Cognitive Function Assessments	-
Healthy control (HC) comparison group	Cognitive Function Assessments	-
Unaffected siblings of the SZ groups	Cognitive Function Assessments	-
Unaffected siblings of the BP group	Cognitive Function Assessments	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States