Clinical trial NCT02033382: Biomarkers in First Episode Schizophrenia
Official title: Biomarkers in First Episode Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder, Depressed Type
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 165
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

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 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.

Eligibility 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

Primary outcomes:
measure: Biomarkers
timeFrame: Baseline
measure: Salivary Cortisol Levels
timeFrame: Baseline and week 8
measure: Salivary Cortisol Levels
timeFrame: Baseline
measure: Change in Salivary Cortisol Levels
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Left Hippocampal Volumetric Integrity (HVI)
timeFrame: Baseline
measure: Cognitive Performance
timeFrame: Baseline, week 8
measure: Annualized Change in Left Hippocampal Volume Integrity
timeFrame: Baseline, week 8
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital
state: New York
Study officials:
References: