CTRI/2021/05/033775
Recruiting
未知
Comparative clinical efficacy and neurobiological correlates of true-vs-sham ECT in patients with clozapine-resistant/intolerant schizophrenia
Department of Psychiatry National Institute of Mental Health and Neuro Sciences0 sites0 target enrollmentTBD
ConditionsHealth Condition 1: F20- Schizophrenia
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: F20- Schizophrenia
- Sponsor
- Department of Psychiatry National Institute of Mental Health and Neuro Sciences
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Schizophrenia Diagnosis (DSM\-5\);
- •2\.Right\-Handedness (Edinburgh Handedness Inventory);
- •3\.Inadequate response to at least two adequate trials of antipsychotic (other than clozapine);
- •4\.Received an adequate trial of clozapine or discontinued/unable to receive an adequate dose of clozapine due to poor tolerability;
- •5\.At least 6\-weeks stable antipsychotic dosage;
- •6\.Score of 4 or more on one or more of items 4 (Conceptual disorganization), 11 (suspiciousness), 12 (hallucinatory behaviour) or 15 (unusual thought content) in Brief psychiatric rating scale OR a score of 4 or more on all the above items combined OR presence of at least 2 items in Bush Francis Catatonia Rating Scale screener
- •7\.Prior consent by the patient for receiving ECT as treatment (obtained by the treating clinical team);
- •8\.Capacity to consent for research studies as per the assessment using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC);
- •9\.Written informed consent.
Exclusion Criteria
- •1\.Severe general medical/neurological comorbidity that precludes ECT or has an effect on cognition and behaviour
- •2\.Received ECT in the past
- •3\.Score of \> 6 on the Calgary Depression Rating Scale
- •4\.Suicidal risk / any psychiatric emergency
- •5\.Pregnancy / Post\-Partum
- •6\.Current psychoactive substance dependence (except caffeine or nicotine)
- •7\.Co\-morbid neurological/medical disease that can affect the brain structure/function
- •8\.Any Contraindication for Magnetic Resonance Imaging
- •9\.Any Contraindication for Transcranial Magnetic Stimulation
- •10\.Any Contraindication for Transcranial Direct Current Stimulation
Outcomes
Primary Outcomes
Not specified
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