Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: True Electroconvulsive therapy: Anaesthesia and muscle relaxation would be used as per the standard practice in the institute by a qualified anaesthesiologist. Thrice-weekly, modified b
Sponsors
Department of Psychiatry National Institute of Mental Health and Neuro Sciences
Central Institute of Psychiatry
Kasturba Medical College
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A 40% improvement in Scale for the Assessment of Positive Symptom (SAPS) scores.Timepoint: Time point 1 (T1)- Baseline (Before part-1 of the study) Time point 2 (T2)- End of Part-1 of the study (End of 9th session or termination of the trial for any predefined reasons) Time point 3 (T3)- End of Part-2 of the study (End of 9th session or termination of the open label trial for any predefined reasons in non-responders of Sham ECT group of Part-1 of the study) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Scale for the Assessment of Negative Symptom (SANS) 2. Brief Psychiatric Rating Scale (BPRS). 3. Calgary Depression Scale for Schizophrenia (CDSS) 4. Clinical Global Impressions (CGI) Scale 5. Sheehan Clinician Global Improvement Global-21 scale 6. Montreal Cognitive Assessment (MoCA) 7. Battery for ECT Related Cognitive (B4ECT-ReCoDe) 8. Brief Assessment of Cognition in Schizophrenia (BACS) 9. Structured Assessment for DisabilityTimepoint: Time point 1 (T1)- Baseline (Before part-1 of the study) Time point 2 (T2)- End of Part-1 of the study (End of 9th session or termination of the trial for any predefined reasons) Time point 3 (T3)- End of Part-2 of the study (End of 9th session or termination of the open label trial for any predefined reasons in non-responders of Sham ECT group of Part-1 of the study);1. Brain magnetic imaging measures (resting-state functional images, diffusion tensor images, glutamate levels at left dorsolateral prefrontal cortex from MR spectroscopy) 2. Electroencephalography measures 3. TMS-tDCS perturbation study metrics 4. Heart Rate Variability measuresTimepoint: Time point 1 (T1)- Baseline (Before part-1 of the study) Time point 2 (T2)- End of Part-1 of the study (End of 9th session or termination of the trial for any predefined reasons) Time point 3 (T3)- End of Part-2 of the study (End of 9th session or termination of the open-label trial for any predefined reasons in non-responders of Sham ECT group of Part-1 of the study) | — |
Countries
India
Contacts
Public ContactJagadisha Thirthalli
National Institute of Mental Health and Neurosciences
Outcome results
None listed