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Treatment Resistant SchizophreniaPhase 4NCT03807882

Comparison of Maintenance ECT Versus Clozapine in Treatment-resistant Schizophrenia

A Phase 4 study testing Bilateral M-ECT and Clozapine in people with Treatment Resistant Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Treatment Resistant Schizophrenia
What is being tested?
Bilateral M-ECT and Clozapine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIndia
Study dates
1 Feb 2019to 30 Jun 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Dept of Psychiatry, Aiims, Bhubaneswar

    Bhubaneswar, Odisha, 751019

Other trials in India

About this study

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

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.

Read the 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.

Being tested
Bilateral M-ECT, Clozapine
Keywords
M-ECT, Clozapine, Psychopathology, Cerebral perfusion
Medical subject headings
Schizophrenia, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral M-ECTOther

    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.

  • ClozapineDrug

    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

Study groups in NCT03807882
Study groupRoleWhat they receive
Test groupExperimentalBilateral Maintenance ECT (B/L M-ECT)
Receives: Other: Bilateral M-ECT
Control groupActive comparatorClozapine 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
Receives: Drug: Clozapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in severity of psychopathology

    Severity will be assessed by Positive and Negative Symptom Scale (PANSS) PANSS Score ranges from 30- 210. A higher score represents more severe psychopathology

    Measured: 24 weeks

Secondary outcomes (5)

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

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

    Measured: 24 weeks

  2. Change in global functionality

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

    Measured: 24 weeks

  3. Change in Cognitive impairment

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

    Measured: 24 weeks

  4. Number of patients receiving rescue medications.

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

    Measured: 24 weeks

  5. Change in regional cerebral blood flow

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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2019
  2. Study start1 Feb 2019
  3. Primary completion31 May 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03807882
Sponsor's protocol ID
T/IM-F/18-19/08
Status last verified
Jun 2021
First submitted
28 Nov 2018
Last updated
16 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kane JM. Management strategies for the treatment of schizophrenia. J Clin Psychiatry. 1999;60 Suppl 12:13-7.

    PubMed 10372604

  • Lieberman JA. Maximizing clozapine therapy: managing side effects. J Clin Psychiatry. 1998;59 Suppl 3:38-43.

    PubMed 9541337

  • Kim HS, Kim SH, Lee NY, Youn T, Lee JH, Chung S, Kim YS, Chung IW. Effectiveness of Electroconvulsive Therapy Augmentation on Clozapine-Resistant Schizophrenia. Psychiatry Investig. 2017 Jan;14(1):58-62. doi: 10.4306/pi.2017.14.1.58. Epub 2016 Dec 29.

    PubMed 28096876

  • Rey JM, Walter G. Half a century of ECT use in young people. Am J Psychiatry. 1997 May;154(5):595-602. doi: 10.1176/ajp.154.5.595.

    PubMed 9137112

  • Chanpattana W, Andrade C. ECT for treatment-resistant schizophrenia: a response from the far East to the UK. NICE report. J ECT. 2006 Mar;22(1):4-12. doi: 10.1097/00124509-200603000-00002.

    PubMed 16633199

  • Chanpattana W, Chakrabhand ML, Sackeim HA, Kitaroonchai W, Kongsakon R, Techakasem P, Buppanharun W, Tuntirungsee Y, Kirdcharoen N. Continuation ECT in treatment-resistant schizophrenia: a controlled study. J ECT. 1999 Sep;15(3):178-92.

    PubMed 10492856

  • Shimizu E, Imai M, Fujisaki M, Shinoda N, Handa S, Watanabe H, Nakazato M, Hashimoto K, Iyo M. Maintenance electroconvulsive therapy (ECT) for treatment-resistant disorganized schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Mar 30;31(2):571-3. doi: 10.1016/j.pnpbp.2006.11.014. Epub 2006 Dec 20.

    PubMed 17187911

  • Grover S, Hazari N, Kate N. Combined use of clozapine and ECT: a review. Acta Neuropsychiatr. 2015 Jun;27(3):131-42. doi: 10.1017/neu.2015.8. Epub 2015 Feb 20.

    PubMed 25697225

  • Petrides G, Malur C, Braga RJ, Bailine SH, Schooler NR, Malhotra AK, Kane JM, Sanghani S, Goldberg TE, John M, Mendelowitz A. Electroconvulsive therapy augmentation in clozapine-resistant schizophrenia: a prospective, randomized study. Am J Psychiatry. 2015 Jan;172(1):52-8. doi: 10.1176/appi.ajp.2014.13060787. Epub 2014 Oct 31.

    PubMed 25157964

  • Lally J, Tully J, Robertson D, Stubbs B, Gaughran F, MacCabe JH. Augmentation of clozapine with electroconvulsive therapy in treatment resistant schizophrenia: A systematic review and meta-analysis. Schizophr Res. 2016 Mar;171(1-3):215-24. doi: 10.1016/j.schres.2016.01.024. Epub 2016 Jan 27.

    PubMed 26827129

  • Siskind DJ, Lee M, Ravindran A, Zhang Q, Ma E, Motamarri B, Kisely S. Augmentation strategies for clozapine refractory schizophrenia: A systematic review and meta-analysis. Aust N Z J Psychiatry. 2018 Aug;52(8):751-767. doi: 10.1177/0004867418772351. Epub 2018 May 6.

    PubMed 29732913

  • Santra A, Kumar R. Brain perfusion single photon emission computed tomography in major psychiatric disorders: From basics to clinical practice. Indian J Nucl Med. 2014 Oct;29(4):210-21. doi: 10.4103/0972-3919.142622.

    PubMed 25400359

  • Ertugrul A, Volkan-Salanci B, Basar K, Karli Oguz K, Demir B, Ergun EL, Senturk S, Erbas B, Cila A, Ulug B. The effect of clozapine on regional cerebral blood flow and brain metabolite ratios in schizophrenia: relationship with treatment response. Psychiatry Res. 2009 Nov 30;174(2):121-9. doi: 10.1016/j.pscychresns.2009.04.007. Epub 2009 Oct 17.

    PubMed 19837567

  • Novak B, Milcinski M, Grmek M, Kocmur M. Early effects of treatment on regional cerebral blood flow in first episode schizophrenia patients evaluated with 99Tc-ECD-SPECT. Neuro Endocrinol Lett. 2005 Dec;26(6):685-9.

    PubMed 16380684

  • Sharafi M. Comparison of Classical and Clozapine Treatment on Schizophrenia Using Positive and Negative Syndrome Scale of Schizophrenia (PANSS) and SPECT Imaging. Int J Med Sci. 2005;2(2):79-86. doi: 10.7150/ijms.2.79. Epub 2005 May 10.

    PubMed 15968344

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bilateral M-ECT and Clozapine in people with Treatment Resistant Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in severity of psychopathology (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03807882, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.

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