NCT06501339

Brief Summary

The pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. Few studies have found ECT as beneficial in TRS, including CRS. However, literature on the role of M-ECT in maintaining the therapeutic gains of acute ECT in CRS is lacking. The objective of the study is to compare the efficacy of M-ECT vs aripiprazole as an add-on to ongoing clozapine on the severity of symptom dimensions, cerebral perfusion, global functioning and cognitions in patients with CRS.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2024

Status
not yet recruiting

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

October 14, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

August 10, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

October 14, 2023

Last Update Submit

July 15, 2024

Conditions

Clozapine Resistant Schizophrenia

Keywords

Clozapine resistantschizophreniaAripiprazolem-ECT

Outcome Measures

Primary Outcomes (1)

  • Change in Positive And Negative Syndome Scale score

    Change from baseline in Total, Positive, negative and general scores with treatment. Minimum value: 30; maximum value: 210. Higher score means worsening of symptoms

    Baseline, 6 weeks, 12 weeks, 24 weeks

Secondary Outcomes (4)

  • Change in regional cerebral blood flow by the SPECT-CT brain

    Baseline, 24 weeks

  • change in the Monteal Cognitive Assessment scores

    Baseline,6 weeks, 12 weeks, 24 weeks

  • change in the Global Assessment of Functioning scores

    Baseline, 6 weeks, 12 weeks, 24 weeks

  • Safety evaluation

    Baseline,6 weeks, 12 weeks, 24 weeks

Study Arms (2)

Maintenance ECT

EXPERIMENTAL
Procedure: maintenance ECT

Aripiprazole

ACTIVE COMPARATOR
Drug: Aripiprazole tablet

Interventions

maintenance ECTPROCEDURE

Frequency of weekly sessions for 1 month, then fortnightly for 5 months

Maintenance ECT
Aripiprazole tabletDRUG

Aripiprazole 10 mg in the morning throughout the study period

Aripiprazole

Eligibility Criteria

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

You may qualify if:

  • Patients clinically diagnosed with CRS (currently under clozapine)
  • Patients aged 18-60 years of either sex.
  • LAR giving voluntary written consent for participation in the study

You may not qualify if:

  • Patient already on ECT or aripiprazole.
  • 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 body part, excluding the mouth. Pregnant and breastfeeding females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Siskind D, Orr S, Sinha S, Yu O, Brijball B, Warren N, MacCabe JH, Smart SE, Kisely S. Rates of treatment-resistant schizophrenia from first-episode cohorts: systematic review and meta-analysis. Br J Psychiatry. 2022 Mar;220(3):115-120. doi: 10.1192/bjp.2021.61.

    PMID: 35049446BACKGROUND

  • Siskind D, Siskind V, Kisely S. Clozapine Response Rates among People with Treatment-Resistant Schizophrenia: Data from a Systematic Review and Meta-Analysis. Can J Psychiatry. 2017 Nov;62(11):772-777. doi: 10.1177/0706743717718167. Epub 2017 Jun 28.

    PMID: 28655284BACKGROUND

  • Campana M, Falkai P, Siskind D, Hasan A, Wagner E. Characteristics and definitions of ultra-treatment-resistant schizophrenia - A systematic review and meta-analysis. Schizophr Res. 2021 Feb;228:218-226. doi: 10.1016/j.schres.2020.12.002. Epub 2021 Jan 14.

    PMID: 33454644BACKGROUND

  • 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: 9137112BACKGROUND

  • 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: 16633199BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Rituparna Maiti, MD

    AIIMS Bhubaneswar

    STUDY DIRECTOR

Central Study Contacts

Biswa Ranjan Mishra, MD

CONTACT

9438884220psych_biswa@aiimsbhubaneswar.edu.in

Debadatta Mohapatra, MD

CONTACT

psych_debadatta@aiimsbhubaneswar.edu.in

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor, Psychiatry

Study Record Dates

First Submitted

October 14, 2023

First Posted

July 15, 2024

Study Start

August 10, 2024

Primary Completion

October 31, 2025

Study Completion

March 31, 2026

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share