SchizophreniaNCT03166098
The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders
An observational study of Schizophrenia and Bipolar Disorder, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- Cognitive Function Assessments
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2016to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Adult
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.
Who may be able to join
- 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
Show all 28Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
- Being tested
- Cognitive Function Assessments
- Keywords
- Psychotic Spectrum Disorders
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Function AssessmentsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis of Schizophrenia | Not described Receives: Diagnostic Test: Cognitive Function Assessments | |
| Diagnosis of Bipolar Disorder | Not described Receives: Diagnostic Test: Cognitive Function Assessments | |
| Unaffected siblings of the SZ groups | Not described Receives: Diagnostic Test: Cognitive Function Assessments | |
| Unaffected siblings of the BP group | Not described Receives: Diagnostic Test: Cognitive Function Assessments | |
| Healthy control (HC) comparison group | Not described Receives: Diagnostic Test: Cognitive Function Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 Years
Magnetic Resonance Spectroscopy will be employed to obtain quantitative metrics of choline (Cho)
Choline Concentration (1H-MRS)
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start5 Jul 2016
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariana Lazar, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166098
- Sponsor's protocol ID
- 15-00754
- Status last verified
- Sep 2022
- First submitted
- 23 May 2017
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dysmyelination in Cognitive Impairment of Psychotic Spectrum Disorders
- ClinicalTrials.gov ID
- NCT03166098
- Acronym / sponsor ID
- 15-00754
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Psychotic Spectrum Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (28 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Function AssessmentsThe 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. | Diagnostic test | Diagnosis of Bipolar Disorder, Diagnosis of Schizophrenia, Healthy control (HC) comparison group, Unaffected siblings of the BP group, Unaffected siblings of the SZ groups |
Primary outcome
DKI(metrics RDextra, faxon, and ADextra) Metrics
Time frame: 6 Years
To compare DKI metrics (faxon, RDextra, and ADextra) in patients with SZ or BP, their unaffected siblings (SIB), and healthy comparison control (HC) subjects
Magnetic Resonance Spectroscopy will be employed to obtain quantitative metrics of choline (Cho)
Time frame: 1 Hour
Choline Concentration (1H-MRS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Lazar, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DKI(metrics RDextra, faxon, and ADextra) Metrics (time frame: 6 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.