A study to assess efficacy of Electroconvulsive Therapy (ECT) in schizophrenia patients who have not responded/tolerated Clozapine

Not Applicable

Conditions: Health Condition 1: F20- Schizophrenia

Registration Number: CTRI/2021/05/033775

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) <br/ ><br>Time point 2 (T2)- End of Part-1 of the study (End of 9th session or termination of the trial for any predefined reasons) <br/ ><br>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 Outcome Measures