Clinical trial NCT03166098: The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders
Official title: The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Keywords: Psychotic Spectrum Disorders
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: DKI(metrics RDextra, faxon, and ADextra) Metrics
timeFrame: 6 Years
measure: Magnetic Resonance Spectroscopy will be employed to obtain quantitative metrics of choline (Cho)
timeFrame: 1 Hour
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mariana Lazar, MD
role: PRINCIPAL_INVESTIGATOR
References: