NCT03807882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

November 28, 2018

Last Update Submit

June 11, 2021

Conditions

Treatment Resistant Schizophrenia

Keywords

M-ECTClozapinePsychopathologyCerebral perfusion

Outcome Measures

Primary Outcomes (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

    24 weeks

Secondary Outcomes (5)

  • Change in illness severity, and global improvement with treatment

    24 weeks

  • Change in global functionality

    24 weeks

  • Change in Cognitive impairment

    24 weeks

  • Number of patients receiving rescue medications.

    24 weeks

  • Change in regional cerebral blood flow

    24 weeks

Study Arms (2)

Test group

EXPERIMENTAL

Bilateral Maintenance ECT (B/L M-ECT)

Other: Bilateral M-ECT

Control group

ACTIVE COMPARATOR

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

Drug: Clozapine

Interventions

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.

Test group
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

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Psychiatry, Aiims, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (17)

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

    PMID: 10372604RESULT

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

    PMID: 9541337RESULT

  • 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.

    PMID: 28096876RESULT

  • 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.

    PMID: 9137112RESULT

  • 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.

    PMID: 16633199RESULT

  • 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.

    PMID: 10492856RESULT

  • 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.

    PMID: 17187911RESULT

  • 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.

    PMID: 25697225RESULT

  • 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.

    PMID: 25157964RESULT

  • 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.

    PMID: 26827129RESULT

  • 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.

    PMID: 29732913RESULT

  • 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.

    PMID: 25400359RESULT

  • 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.

    PMID: 19837567RESULT

  • 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.

    PMID: 16380684RESULT

  • 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.

    PMID: 15968344RESULT

  • Howes OD, McCutcheon R, Agid O, de Bartolomeis A, van Beveren NJ, Birnbaum ML, Bloomfield MA, Bressan RA, Buchanan RW, Carpenter WT, Castle DJ, Citrome L, Daskalakis ZJ, Davidson M, Drake RJ, Dursun S, Ebdrup BH, Elkis H, Falkai P, Fleischacker WW, Gadelha A, Gaughran F, Glenthoj BY, Graff-Guerrero A, Hallak JE, Honer WG, Kennedy J, Kinon BJ, Lawrie SM, Lee J, Leweke FM, MacCabe JH, McNabb CB, Meltzer H, Moller HJ, Nakajima S, Pantelis C, Reis Marques T, Remington G, Rossell SL, Russell BR, Siu CO, Suzuki T, Sommer IE, Taylor D, Thomas N, Ucok A, Umbricht D, Walters JT, Kane J, Correll CU. Treatment-Resistant Schizophrenia: Treatment Response and Resistance in Psychosis (TRRIP) Working Group Consensus Guidelines on Diagnosis and Terminology. Am J Psychiatry. 2017 Mar 1;174(3):216-229. doi: 10.1176/appi.ajp.2016.16050503. Epub 2016 Dec 6.

    PMID: 27919182RESULT

  • Mishra BR, Agrawal K, Biswas T, Mohapatra D, Nath S, Maiti R. Comparison of Acute Followed by Maintenance ECT vs Clozapine on Psychopathology and Regional Cerebral Blood Flow in Treatment-Resistant Schizophrenia: A Randomized Controlled Trial. Schizophr Bull. 2022 Jun 21;48(4):814-825. doi: 10.1093/schbul/sbac027.

    PMID: 35556138DERIVED

MeSH Terms

Conditions

Schizophrenia, Treatment-Resistant

Interventions

Clozapine

Condition Hierarchy (Ancestors)

SchizophreniaSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • RITUPARNA MAITI, M.D

    AIIMS Bhubaneswar

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ADDITIONAL PROFESSOR

Study Record Dates

First Submitted

November 28, 2018

First Posted

January 17, 2019

Study Start

February 1, 2019

Primary Completion

May 31, 2020

Study Completion

June 30, 2020

Last Updated

June 16, 2021

Record last verified: 2021-06

Locations

IN(1)