The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders



Status:Recruiting
Conditions:Cognitive Studies, Schizophrenia, Psychiatric, Psychiatric, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 30
Updated:4/22/2018
Start Date:July 5, 2016
End Date:July 5, 2020
Contact:David Stoffel
Email:David.Stoffel@nyumc.org
Phone:212 263 3945

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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.


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.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Mariana Lazar, MD
Phone: 212-263-3945
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