Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia

July 15, 2024 updated by: BISWA RANJAN MISHRA, All India Institute of Medical Sciences, Bhubaneswar

Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole on Psychopathology and Cerebral Perfusion in Clozapine-resistant Schizophrenia: a Randomized, Double-blind Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aripiprazole
Drug: Aripiprazole tablet
Aripiprazole 10 mg in the morning throughout the study period
Experimental: Maintenance ECT
Procedure: maintenance ECT
Frequency of weekly sessions for 1 month, then fortnightly for 5 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Positive And Negative Syndome Scale score
Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in regional cerebral blood flow by the SPECT-CT brain
Time Frame: Baseline, 24 weeks
Change frome baseline in regional cerebral blood flow by the SPECT-CT brain with treatment
Baseline, 24 weeks
Safety evaluation
Time Frame: Baseline,6 weeks, 12 weeks, 24 weeks
Number of events observed in each patient and patients with at least one adverse event
Baseline,6 weeks, 12 weeks, 24 weeks
change in the Monteal Cognitive Assessment scores
Time Frame: Baseline,6 weeks, 12 weeks, 24 weeks
change from baseline in the Monteal Cognitive Assessment scores with treatment. Minimum Value: 0 Maximum Value: 30: Higher score indicate better cognitive function
Baseline,6 weeks, 12 weeks, 24 weeks
change in the Global Assessment of Functioning scores
Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks
change from baseline in the Global Assessment of Functioning scores with treatment Minimum Value: 0 Maximum Value: 100: Higher score indicate better global functioning
Baseline, 6 weeks, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Study Director: Rituparna Maiti, MD, AIIMS Bhubaneswar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T/EMF/Psych/23-24/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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