Biomarkers in First Episode Schizophrenia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 16 - 40 |
| Updated: | 7/14/2017 |
| Start Date: | July 2012 |
| End Date: | June 2018 |
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
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 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.
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.
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
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