NCT03166098|Completed
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Sponsor study identifier
observational
139
1 country
1
Study Start
July 5, 2016
Actual (reported)Primary Completion
March 1, 2022
Actual (reported)Study Completion
March 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 5, 2016
Actual (reported)May 23, 2017
Actual (reported)May 24, 2017
Actual (reported)March 1, 2022
Actual (reported)March 1, 2022
Actual (reported)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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study will include patients with a diagnosis of Schizophrenia or Bipolar Disorder with Psychotic features, their unaffected siblings, and comparison healthy subjects.
New York University School of Medicine
New York, New York, 10016, United States
Mariana Lazar, MD
NYU Langone Health
139 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2017
First Posted
May 24, 2017
Study Start
July 5, 2016
Actual (reported)Bio-equivalence Study Between SAPHRIS and Asenapine
Contact the study team to confirm eligibility.
Primary Completion
March 1, 2022
Actual (reported)Study Completion
March 1, 2022
Actual (reported)Last Updated
September 14, 2022
Record last verified: 2022-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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