N/A N=165

Biomarkers in First Episode Schizophrenia

Schizophrenia · Schizophreniform Disorder · Schizoaffective Disorder, Depressed Type

Bottom Line

View on ClinicalTrials.gov: NCT02033382 ↗

Enrolled (actual)

165

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Biomarkers — 287.37; 340.83; 492.33; 420.17 pg/mL

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric, Adult · 16+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Biomarkers	287.37; 340.83; 492.33; 420.17; 130.44; 125.13	—
PRIMARY Salivary Cortisol Levels	4.88; 6.56	—
PRIMARY Salivary Cortisol Levels	4.88; 6.56	—
PRIMARY Change in Salivary Cortisol Levels	7.41; 4.36	—
SECONDARY Left Hippocampal Volumetric Integrity (HVI)	.9512; .9275	—
SECONDARY Cognitive Performance	47.50; 34; 49.50; 42.50	—
SECONDARY Annualized Change in Left Hippocampal Volume Integrity	0.004535; -0.03027	—

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02033382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.