Status:
UNKNOWN
Response to Clozapine in Treatment Resistant Schizophrenia: A Longitudinal Magnetic Resonance Spectroscopy Study
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to investigate the relationship between glutamate and related brain chemicals and treatment response to clozapine in patients with treatment-resistant schizophrenia.
Detailed Description
This study will be a prospective proton spectroscopy (1H-MRS) study designed to compare the levels of glutamate, glutamine, glx, and glutathione in age- and gender- matched patients with poor response...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Participants with TRS:
- DSM-IV/SCID diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or psychotic disorder NOS.
- Age 18 years or older at time of scanning
- History of failure to respond to at least two previous sequential antipsychotic treatments different to clozapine, each attaining a chlorpromazine daily dose of≥ 400 mg for a duration ≥ 6 consecutive weeks.Long-acting antipsychotic treatment will not be allowed during the last trial prior to clozapine in order to avoid residual concentrations or effects.Failure of treatment will be defined by a Clinical Global Impression Severity (CGI-Severity) score of ≥4 and score of ≥4 on 2 Positive and Negative Syndrome Scale (PANSS) positive symptom items. The CGI-Severity or Global Assessment of Functioning (GAF) will be completed retrospectively based on information provided by the participant, participant's psychiatrist, medical chart, or other sources of available collateral information.
- Exclusion Criteria for Participants with TRS:
- Incapacity to provide consent to participate in the research study.
- Substance abuse or dependence (within past six months), excluding nicotine and caffeine.
- Positive urine drug screen for drugs of abuse.
- Metal implants or a pace-maker that would preclude the MRI scan.
- History of head trauma resulting in loss of consciousness \> 30 minutes that required medical attention.
- Unstable physical illness or significant neurological disorder including a seizure disorder.
- Size of head, neck, and body being unable to fit MRI scanners.
- Refusal to provide consent to investigator to communicate with physician of record to obtain collateral information.
- Psychiatric concerns raised by the physician of record regarding participation in the study.
- Currently taking medications that may directly impact the glutamatergic system (i.e. lamotrigine, topiramate, memantine or N-acetylcysteine)
- ECT, MST or TMS in the past 6 months
- Inclusion criteria for Healthy Controls:
- Age of 18 and older at time of scanning
- Being capable to consent to study procedures
- Absence of history of psychiatric illness using the Mini-International Neuropsychiatric Interview (MINI)
- Exclusion criteria for Healthy Controls:
- First degree family member with primary psychotic disorder
- Substance abuse or dependence (within past six months), excluding nicotine and caffeine.
- Positive urine drug screen for drugs of abuse
- Pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude the MRI scan
- Clinically significant claustrophobia
- History of head trauma resulting in loss of consciousness \> 30 minutes that required medical attention
- Size of head, neck, and body being unable to fit MRI scanners
- Unstable physical illness or significant neurological disorder including a seizure disorder
Exclusion
Key Trial Info
Start Date :
April 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2022
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT02714894
Start Date
April 1 2016
End Date
July 30 2022
Last Update
June 3 2022
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8