The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders

NCT ID: NCT03166098

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 139 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-05
• Study Completion Date: 2022-03-01

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Diagnosis of Schizophrenia

Cognitive Function Assessments

Intervention Type: 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

Cognitive Function Assessments

Intervention Type: 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.

Unaffected siblings of the SZ groups

Cognitive Function Assessments

Intervention Type: 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.

Unaffected siblings of the BP group

Cognitive Function Assessments

Intervention Type: 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.

Healthy control (HC) comparison group

Cognitive Function Assessments

Intervention Type: 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.

Interventions

Cognitive 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariana Lazar, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-00754

Identifier Type: -

Identifier Source: org_study_id