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The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Schizophrenia
Bipolar Disorder

Treatments

Diagnostic Test: Cognitive Function Assessments

Study type

Observational

Funder types

Other

Identifiers

NCT03166098
15-00754

Details and patient eligibility

About

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.

Enrollment

139 patients

Sex

All

Ages

18 to 30 years old

Volunteers

No Healthy Volunteers

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.

Trial design

139 participants in 5 patient groups

Diagnosis of Schizophrenia
Treatment:
Diagnostic Test: Cognitive Function Assessments
Diagnosis of Bipolar Disorder
Treatment:
Diagnostic Test: Cognitive Function Assessments
Unaffected siblings of the SZ groups
Treatment:
Diagnostic Test: Cognitive Function Assessments
Unaffected siblings of the BP group
Treatment:
Diagnostic Test: Cognitive Function Assessments
Healthy control (HC) comparison group
Treatment:
Diagnostic Test: Cognitive Function Assessments

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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