Comparison of Maintenance ECT Versus Clozapine in Treatment-resistant Schizophrenia

Phase 4

Completed

• Conditions: Treatment Resistant Schizophrenia
• Interventions: Other: Bilateral M-ECT; Drug: Clozapine

• Registration Number: NCT03807882
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Brief Summary

The proposed study will be conducted to compare the efficacy of maintenance ECT (M-ECT) vs Clozapine in treatment resistant schizophrenia (TRS) in terms of change in psychopathology measures and cerebral hemodynamics.

Detailed Description

The proposed study is a prospective, randomized clinical trial in patients suffering from treatment-resistant schizophrenia (TRS) and will be conducted in the Department of Psychiatry, AIIMS, Bhubaneswar, over a period of 16 months. Sixty patients with TRS (TRRIP consensus criteria, 2017), fulfilling the inclusion and exclusion criteria will be recruited for the study. Written informed consent will be taken after explaining the objectives and procedure of the study in detail. The detailed history, relevant social-demographic and clinical data will be collected in a structured case record form (CRF). At baseline, PANSS will be administered to determine the severity of positive symptoms, negative symptoms, and general psychopathology, Global assessment of functioning (GAF), and CGI to determine the baseline severity of the illness and improvement with treatment and MoCA to assess change in cognitive impairment. Before starting the treatment, brain SPECT-CT will be done to measure baseline regional brain blood perfusion. The study cohort will be randomized into two treatment groups by computer-generated random numbers, each group comprising 30 patients. One group will receive maintenance ECT (M-ECT) following acute treatment of bilateral ECT of six sessions along with ongoing antipsychotic and the other group will be treated with Clozapine monotherapy. PANSS, GAF, CGI, MoCA will be re-administered at 6 weeks, 3 months, and 6 months follow-up visits to compare the changes within each group and between the groups. Post-treatment SPECT-CT of the brain will be done at the end of 6 months to document changes in the regional cerebral blood perfusion.

Study Timeline

• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-17
• Study Start: 2019-02-01
• Primary Completion: 2020-05-31
• Study Completion: 2020-06-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-11
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients clinically diagnosed with treatment-resistant schizophrenia (TRS) (TRRIP consensus criteria).
• Patients aged 18-60 years of either sex.
• Patients giving voluntary written consent for participation in the study

Exclusion Criteria

• Patient already on Clozapine or ECT.
• History of psychoactive substance abuse or dependence.
• Co-morbid psychiatric, major medical, or neurological disorders.
• History of organicity or significant head injury.
• Pacemaker or metal in any part of the body excluding the mouth.
• Pregnant and breastfeeding females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Bilateral M-ECT	Bilateral Maintenance ECT (B/L M-ECT)
Control group	Clozapine	Clozapine monotherapy. Clozapine will be given in accordance with Maudsley guideline: 12.5 mg on the first day, followed by 12.5mg twice daily on the second day, followed by 25mg twice daily for next two days and then increment of 25mg every two days till the target dose of 250-400 mg per day in two divided doses as per tolerability of the patients

Primary Outcome Measures

Name	Time	Method
Change in severity of psychopathology	24 weeks	Severity will be assessed by Positive and Negative Symptom Scale (PANSS) PANSS Score ranges from 30- 210. A higher score represents more severe psychopathology

Secondary Outcome Measures

Name	Time	Method
Change in global functionality	24 weeks	Assessed by change in Global assessment of functioning (GAF) scores.
Number of patients receiving rescue medications.	24 weeks	Patients with "treatment relapse" or "treatment non-response" will receive rescue medications.
Change in regional cerebral blood flow	24 weeks	Change in regional cerebral blood flow will be measured by SPECT-CT Brain
Change in illness severity, and global improvement with treatment	24 weeks	Assessed by change in Clinical Global Impression Schizophrenia (CGI-SCH) scores.
Change in Cognitive impairment	24 weeks	Assessed by change in Montreal Cognitive Assessment (MoCA) scores.

Trial Locations

Locations (1)

Dept of Psychiatry, Aiims, Bhubaneswar; 🇮🇳 Bhubaneswar, Odisha, India