Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Schizophrenia (SZ) is a highly debilitating neuropsychiatric disorder of young adulthood
onset and a leading cause of disability worldwide. While treatments delivered at early stages
of the disorder may be effective at reducing psychosis or altering the course of the disease,
there are currently no biomarkers capable of identifying subjects in early stages of SZ who
are likely to respond to treatment and would be good candidates for available proactive,
symptomatic or future disease-modifying treatments; or those who would not respond and can be
spared unnecessary medication exposure. The lack of these vitally important biomarkers
provides a compelling rationale for the present multidisciplinary research project, which
aims to develop and validate highly promising noninvasive and objective proton magnetic
resonance spectroscopy (1H MRS)-based biomarkers for monitoring treatment response in early
stages of SZ. In support of the viability of this overall objective is a large body of data,
reported by the applicants and others, that show (a) that levels of glutamate (Glu) and -
aminobutyric acid (GABA) - respectively, the major excitatory and inhibitory amino acid
neurotransmitter systems - are abnormally elevated in medication-naïve and unmedicated first
episode and chronic SZ patients; (b) that the effect of treatment with antipsychotic
medications in these populations may be to lower or normalize brain levels of both Glu and
GABA. To investigate the potential of these in vivo brain Glu and GABA abnormalities to serve
as biomarkers of treatment response in early-stage SZ, the applicants propose to use 1H MRS
to measure Glu and GABA levels in the largest cohort of medication-free SZ subjects to date,
at baseline and following 4 weeks of antipsychotic treatment.
Phase:
Phase 4
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
Columbia University National Institute of Mental Health (NIMH) New York State Psychiatric Institute