Skip to content

The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03166098
Enrollment
139
Registered
2017-05-24
Start date
2016-07-05
Completion date
2022-03-01
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Schizophrenia

Keywords

Psychotic Spectrum Disorders

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.

Interventions

DIAGNOSTIC_TESTCognitive 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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
DKI(metrics RDextra, faxon, and ADextra) Metrics6 YearsTo 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 HourCholine Concentration (1H-MRS)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026