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OpenTrials
Completed

NCT Number: NCT03166098

The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Function Assessments

Diagnostic Test

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.

Primary outcomes

  1. DKI(metrics RDextra, faxon, and ADextra) Metrics

    Time frame: 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

  2. Magnetic Resonance Spectroscopy will be employed to obtain quantitative metrics of choline (Cho)

    Time frame: 1 Hour

    Choline Concentration (1H-MRS)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
May 24, 2017
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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