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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
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 70 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 70 schizophrenic patients and 70 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | Compare biomarkers for inflammation, BDNF, oxidative stress, glucocorticoids and folate/methylation status in medication-naïve schizophrenia/schizophreniform subjects and matched healthy controls to identify illness-related factors. | Baseline |
| Salivary Cortisol Levels | Compare biomarkers at baseline and after 8 weeks of risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects to identify treatment-related factors. Since Blood and Saliva was only collected from First Episode participants (FEP) at week 8 (not from healthy controls) these results only report the baseline and week 8 biomarker levels for FEP participants who completed week 8. | Baseline and week 8 |
| Salivary Cortisol Levels | Compare biomarkers for stress (salivary cortisol) in medication-naïve schizophrenia/schizophreniform subjects and matched healthy controls to identify illness-related factors. | Baseline |
| Change in Salivary Cortisol Levels | Compare salivary cortisol at baseline and after 8 weeks of risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects to identify treatment-related factors. Since Blood and Saliva was only collected from First Episode participants (FEP) at week 8 (not from healthy controls) these results only report the baseline and week 8 biomarker levels for FEP participants who completed week 8. | Baseline and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Left Hippocampal Volumetric Integrity (HVI) | Compare hippocampal volume in medication-naïve schizophrenia/schizophreniform subjects and healthy controls and examine whether biomarkers predict differences between groups in baseline hippocampal volume. | Baseline |
| Cognitive Performance |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be 70 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 70 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 as well as through the inpatient / outpatient services at Shanghai Mental Health Center .
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue Hospital | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls | Age and gender matched healthy controls |
| FG001 | Patients | Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Controls | Age and gender matched healthy controls |
| BG001 | Patients | Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Biomarkers | Compare biomarkers for inflammation, BDNF, oxidative stress, glucocorticoids and folate/methylation status in medication-naïve schizophrenia/schizophreniform subjects and matched healthy controls to identify illness-related factors. | Not all biomarkers were available for analysis for all subjects. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Controls | Age and gender matched healthy controls |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurred Vision | Eye disorders | BLURRED VISION | Patient reported blurred vision |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | NYU Langone Health | 646-754-4843 | donald.goff@nyumc.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Compare cognitive performance on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) in medication- naïve schizophrenia/schizophreniform subjects and healthy controls and examine whether biomarkers predict differences between groups in baseline cognitive performance. The composite score on the MCCB is calculated by the software using all tests administered. The composite score is a t-score assuming the mean score (50%) is the normative performance of the general population. The composite score ranges from 0-100 with a standard deviation of 10. A score greater than 50 implies a score better than the average population norm and a score less than 50 indicates performance worse than the general population norm. 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. |
| Baseline, week 8 |
| Annualized Change in Left Hippocampal Volume Integrity | Compare hippocampal volume in medication-naïve schizophrenia/schizophreniform subjects before and after 8 weeks treatment with antipsychotic to assess evidence for early neurotoxicity. This outcome measure reports annualized rate of change in Left Hippocampal Volume Integrity (LHVI) because a few participants had a delay in their week 8 visit. | Baseline, week 8 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
| Primary | Salivary Cortisol Levels | Compare biomarkers at baseline and after 8 weeks of risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects to identify treatment-related factors. Since Blood and Saliva was only collected from First Episode participants (FEP) at week 8 (not from healthy controls) these results only report the baseline and week 8 biomarker levels for FEP participants who completed week 8. | Analysis was done for first episode participants who completed both Baseline and Week 8 only. | Posted | Median | Inter-Quartile Range | pg/mL | Baseline and week 8 |
|
|
|
| Primary | Salivary Cortisol Levels | Compare biomarkers for stress (salivary cortisol) in medication-naïve schizophrenia/schizophreniform subjects and matched healthy controls to identify illness-related factors. | Posted | Median | Inter-Quartile Range | µg/dL | Baseline |
|
|
|
| Primary | Change in Salivary Cortisol Levels | Compare salivary cortisol at baseline and after 8 weeks of risperidone treatment in medication-naïve schizophrenia/schizophreniform subjects to identify treatment-related factors. Since Blood and Saliva was only collected from First Episode participants (FEP) at week 8 (not from healthy controls) these results only report the baseline and week 8 biomarker levels for FEP participants who completed week 8. | Analysis was done for first episode subjects who completed both Baseline and Week 8 only. | Posted | Median | Inter-Quartile Range | µg/dL | Baseline and week 8 |
|
|
|
| Secondary | Left Hippocampal Volumetric Integrity (HVI) | Compare hippocampal volume in medication-naïve schizophrenia/schizophreniform subjects and healthy controls and examine whether biomarkers predict differences between groups in baseline hippocampal volume. | Posted | Median | Inter-Quartile Range | % of hippocampal volumetric integrity | Baseline |
|
|
|
| Secondary | Cognitive Performance | Compare cognitive performance on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) in medication- naïve schizophrenia/schizophreniform subjects and healthy controls and examine whether biomarkers predict differences between groups in baseline cognitive performance. The composite score on the MCCB is calculated by the software using all tests administered. The composite score is a t-score assuming the mean score (50%) is the normative performance of the general population. The composite score ranges from 0-100 with a standard deviation of 10. A score greater than 50 implies a score better than the average population norm and a score less than 50 indicates performance worse than the general population norm. 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. | Data provided only for subjects who completed assessments at both time points. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, week 8 |
|
|
|
| Secondary | Annualized Change in Left Hippocampal Volume Integrity | Compare hippocampal volume in medication-naïve schizophrenia/schizophreniform subjects before and after 8 weeks treatment with antipsychotic to assess evidence for early neurotoxicity. This outcome measure reports annualized rate of change in Left Hippocampal Volume Integrity (LHVI) because a few participants had a delay in their week 8 visit. | This analysis includes participants that completed both baseline and week 8 visits. | Posted | Median | Inter-Quartile Range | Percentage of standard hippocampal vol. | Baseline, week 8 |
|
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|
| 0 |
| 73 |
| 0 |
| 73 |
| EG001 | Patients | Participants diagnosed with Schizophrenia, schizophreniform disorder, or schizoaffective disorder, depressed type that are naive to anti-psychotic treatment. | 0 | 79 | 1 | 79 |
| Hypertension | Cardiac disorders | HYPERTENSION | BP sitting 130/100, standing 130/95 |
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| Interleukin 8 |
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| Interferon gamma |
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| Tumor necrosis factor |
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| Aspartate |
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| Glutamate |
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| Lactate |
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| Homocysteine |
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| BDNF |
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| Thioredoxin |
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| S100B |
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