Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia

  • STATUS
    Recruiting
  • End date
    Oct 9, 2023
  • participants needed
    90
  • sponsor
    Weill Medical College of Cornell University
Updated on 9 August 2022
Accepts healthy volunteers

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.

Details
Condition Schizophrenia Spectrum and Other Psychotic Disorders
Treatment risperidone
Clinical Study IdentifierNCT03323437
SponsorWeill Medical College of Cornell University
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or females between the ages of 18-35
less than five years (<60 months) of active Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
Capacity to provide informed consent
No major medical or neurological illness
Medication free (3 weeks without antipsychotic medications)

Exclusion Criteria

Current alcohol or drug abuse (<1 month) or substance dependence (<6 months) or substances used within one day of the imaging study
Pregnant or lactating women or women of child-bearing potential, who are either not surgically-sterile or, for outpatients, not using appropriate methods of birth control
Intelligence Quotient (IQ) <70
Acute risk for suicide or violence
Presence of pacemaker or any metallic objects in the body that would interfere with the MRS or cause MRI safety problems
Claustrophobia
Any organic brain disorder (including epilepsy, mental retardation, or a medical condition whose pathology or treatment would likely alter the presentation or treatment of SZ
Individuals on anti-epileptic medications (e.g., valproate, carbamazepine) that may affect GABA or Glu
Unstable medical or neurological condition
DSM-V diagnosis of bipolar disorder I
DSM-V diagnosis of major depression with psychotic features
History of non-response to or non-tolerance of Risperidone
Inclusion Criteria (Healthy Controls)
Male or females between the ages of 18-35
less than five years (<60 months) of active DSM diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
No major medical or neurological illness
Exclusion Criteria (Healthy Controls)
Current alcohol or drug abuse (<1 month) or substance dependence (<6 months) or substances used within one day of the imaging study
Pregnant or lactating women or women of child-bearing potential, who are either not surgically-sterile or, for outpatients, not using appropriate methods of birth control
IQ<70
Acute risk for suicide or violence
Presence of pacemaker or any metallic objects in the body that would interfere with the MRS or cause MRI safety problems
Claustrophobia
History of psychotropic medication use such as antipsychotics or antidepressants
Any first-degree family history of psychotic illness
Personal history of any DSM Axis I disorder
Individuals on anti-epileptic medications (e.g., valproate, carbamazepine) that may affect GABA or Glu
Unstable medical or neurological condition
Any organic brain disorder (including epilepsy, mental retardation, or a medical condition whose pathology or treatment would likely alter the presentation or treatment of SZ
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