Status:
COMPLETED
Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
New York State Psychiatric Institute
Columbia University
Conditions:
Schizophrenia Spectrum and Other Psychotic Disorders
Eligibility:
All Genders
18-35 years
Phase:
PHASE4
Brief 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 m...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Patients):
- 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 (Patients):
- 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
Exclusion
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03323437
Start Date
September 15 2017
End Date
May 31 2023
Last Update
May 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
New York State Psychiatric Institute & Columbia University
New York, New York, United States, 10032