Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomarkers in First Episode Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033382
Recruitment Status : Unknown
Verified July 2017 by NYU Langone Health.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2014
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This study will identify and evaluate relevant biomarkers and structural brain imaging for understanding potential biological illness related mechanisms in medication-naïve subjects with early psychosis before and after initiation of antipsychotic medication

Condition or disease
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder, Depressed Type

Detailed Description:

It is currently unknown whether deterioration early in the course of psychotic illness represents medication toxicity or the natural course of the illness. The study will help clarify this issue in observing 20 schizophrenic patients before and after they are prescribed an antipsychotic via standard of care.

In addition, schizophrenia is a heterogeneous disorder and a putative brain-derived neurotrophic factor (BDNF) deficit, while possibly a common pathway, may not fully capture the biological diversity—the supplemental biomarkers will allow us to perform a more comprehensive assessment of factors contributing to clinical course. Taken together analysis of these biomarkers in relation to clinical course and in relation to healthy subjects will inform us about biological mechanisms contributing to illness onset, effects of antipsychotic medication on these mechanisms, and the predictive value of the biomarkers for clinical course. This information will provide the foundation for future early intervention trials targeting biological mechanisms utilizing a personalized medicine approach.

The baseline visit for 20 schizophrenic patients and 20 healthy age and gender matched controls consists of structural and functional MRI in addition to a blood draw for biomarkers including BDNF, inflammation markers, DNA, oxidative stress, and folate status and additionally a salivary cortisol sample collection. Biomarkers and imaging will be repeated after 8 weeks of antipsychotic treatment in patients.


Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarkers in First Episode Schizophrenia
Study Start Date : July 2012
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
Healthy Controls
Age and gender matched healthy controls
Patients
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.



Primary Outcome Measures :
  1. Biomarkers [ Time Frame: Baseline ]
    Compare biomarkers for inflammation, BDNF, oxidative stress, glucocorticoids and folate/methylation status in 20 medication-naïve schizophrenia/schizophreniform subjects and 20 matched healthy controls to identify illness-related factors.

  2. Change in Biomarkers [ Time Frame: Baseline, week 4, week 8 ]
    Compare biomarkers at baseline and after 8 weeks of risperidone treatment in 20 medication-naïve schizophrenia/schizophreniform subjects to identify treatment-related factors.


Secondary Outcome Measures :
  1. Grey Matter [ Time Frame: Baseline ]
    Compare gray matter volume in 20 medication- naïve schizophrenia/schizophreniform subjects and 20 healthy controls and examine whether biomarkers predict differences between groups in baseline gray matter volume.

  2. Cognitive Performance [ Time Frame: Baseline, week 8 ]
    Compare cognitive performance on the MATRICS battery in 20 medication- naïve schizophrenia/schizophreniform subjects and 20 healthy controls and examine whether biomarkers predict differences between groups in baseline cognitive performance. For schizophrenia subjects who complete 8 weeks of antipsychotic treatment, week 8 MATRICS testing results will be used to minimize the effect of psychosis on cognitive performance.

  3. Change in Grey Matter [ Time Frame: Baseline, week 8 ]
    Compare gray matter volume in 20 medication-naïve schizophrenia/schizophreniform subjects before and after 8 weeks treatment with antipsychotic to assess evidence for early neurotoxicity.


Biospecimen Retention:   Samples With DNA
  • Whole Blood
  • DNA
  • Saliva
  • Serum
  • Plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be 20 patients , ages 15-40, with first episode schizophrenia or schizophreniform disorder with onset before age 35 who are medication naive and do not meet criteria for major depression or significant suicidal ideation or substance abuse (except nicotine) and 20 age and gender matched healthy controls. Subjects will be recruited by physicians in the Bellevue Hospital emergency room, outpatient clinic and on the Bellevue psychiatric inpatient units.

Potential subjects will be identified by clinicians and asked whether they would like to speak to a researcher. Healthy subjects will be recruited through advertising by using a flyer. Potential subjects referred by a clinician or expressing interest in participation will meet with study staff for an informational meeting. The study will be explained to the individual and in the event that he or she is interested in participating will then be given the consent form to read and review.

Criteria

Inclusion Criteria:

  1. Male or female
  2. Ages 15-40 years
  3. Schizophrenia, any subtype or Schizophreniform disorder
  4. Sufficient proficiency in English or Spanish to complete assessments (US)

Exclusion Criteria:

  1. Major depression by the Diagnostic and Statistical Manual of Mental Disorders IV criteria
  2. Calgary Depression Scale for Schizophrenia (CDSS) score of 7 or greater.
  3. Clinical Global Assessment of Severity of Suicidality of 3 (moderate) or greater.
  4. Serious suicide attempt within three years
  5. Treatment with an antipsychotic or antidepressant within the last six months
  6. Active alcohol or other substance abuse or dependence within one month
  7. Unstable medical illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033382


Locations
Layout table for location information
United States, New York
Bellevue Hospital
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02033382     History of Changes
Other Study ID Numbers: 12-02903
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders