Biomarkers in First Episode Schizophrenia
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|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
|Condition or disease|
|Schizophrenia Schizophreniform Disorder Schizoaffective Disorder, Depressed Type|
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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Biomarkers in First Episode Schizophrenia|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||June 2018|
Age and gender matched healthy controls
Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment.
- 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.
- 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.
- 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.
- 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.
- 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
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
|United States, New York|
|New York, New York, United States, 10016|