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Clinical Trials/CTRI/2021/05/033775
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

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Department of Psychiatry National Institute of Mental Health and Neuro Sciences

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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