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

All India Institute of Medical Sciences, Bhubaneswar

Status and phase: Not yet enrolling; Phase 4

Conditions: Clozapine Resistant Schizophrenia

Treatments: Drug: Aripiprazole tablet; Procedure: maintenance ECT

Study type: Interventional

Funder types: Other

Identifiers

NCT06501339

T/EMF/Psych/23-24/13

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Maintenance ECT

Experimental group

Treatment:

Procedure: maintenance ECT

Aripiprazole

Active Comparator group

Treatment:

Drug: Aripiprazole tablet