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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-10

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Clozapine Resistant Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Maintenance ECT

Group Type EXPERIMENTAL

maintenance ECT

Intervention Type PROCEDURE

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

Aripiprazole

Group Type ACTIVE_COMPARATOR

Aripiprazole tablet

Intervention Type DRUG

Aripiprazole 10 mg in the morning throughout the study period

Interventions

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maintenance ECT

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

Intervention Type PROCEDURE

Aripiprazole tablet

Aripiprazole 10 mg in the morning throughout the study period

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No