The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

NCT03166098 | Completed

• 1 other identifier: 15-00754
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Bipolar Disorder

Keywords

Psychotic Spectrum Disorders

Outcome Measures

Primary Outcomes (2)

• 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

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

  Choline Concentration (1H-MRS)

  1 Hour

Study Arms (5)

Diagnosis of Schizophrenia

Diagnostic Test: Cognitive Function Assessments

Diagnosis of Bipolar Disorder

Diagnostic Test: Cognitive Function Assessments

Unaffected siblings of the SZ groups

Diagnostic Test: Cognitive Function Assessments

Unaffected siblings of the BP group

Diagnostic Test: Cognitive Function Assessments

Healthy control (HC) comparison group

Diagnostic Test: Cognitive Function Assessments

Interventions

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.

Diagnosis of Bipolar Disorder; Diagnosis of Schizophrenia; Healthy control (HC) comparison group; Unaffected siblings of the BP group; Unaffected siblings of the SZ groups

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include patients with a diagnosis of Schizophrenia or Bipolar Disorder with Psychotic features, their unaffected siblings, and comparison healthy subjects.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Mariana Lazar, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 24, 2017
• Study Start: July 5, 2016
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

US (1)