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NCT Number: NCT03807882

Comparison of Maintenance ECT Versus Clozapine in Treatment-resistant Schizophrenia

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.

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Key information

Conditions

Treatment Resistant Schizophrenia Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Treatment-Resistant

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept of Psychiatry, Aiims, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bilateral M-ECT

Other

Following acute treatment with bilateral ECT of 6 sessions over a period of two weeks, Bilateral M-ECT will be administered at a frequency of 1 session/week for one month, then 1 session / 2 weeks for 2 months and then 1 session/month for next 3 months.

Clozapine

Drug

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 outcomes

  1. Change in severity of psychopathology

    Time frame: 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 outcomes

  1. Change in illness severity, and global improvement with treatment

    Time frame: 24 weeks

    Assessed by change in Clinical Global Impression Schizophrenia (CGI-SCH) scores.

  2. Change in global functionality

    Time frame: 24 weeks

    Assessed by change in Global assessment of functioning (GAF) scores.

  3. Change in Cognitive impairment

    Time frame: 24 weeks

    Assessed by change in Montreal Cognitive Assessment (MoCA) scores.

  4. Number of patients receiving rescue medications.

    Time frame: 24 weeks

    Patients with "treatment relapse" or "treatment non-response" will receive rescue medications.

  5. Change in regional cerebral blood flow

    Time frame: 24 weeks

    Change in regional cerebral blood flow will be measured by SPECT-CT Brain

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

Comparison of Maintenance ECT Versus Clozapine on Psychopathology and Cerebral Hemodynamics in Treatment-resistant Schizophrenia: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 17, 2019
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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