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

Phase 4

Not yet recruiting

• Conditions: Clozapine Resistant Schizophrenia
• Interventions: Procedure: maintenance ECT; Drug: Aripiprazole tablet

• Registration Number: NCT06501339
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-14
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Study Start: 2024-08-10
• Primary Completion: 2025-10-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintenance ECT	maintenance ECT	-
Aripiprazole	Aripiprazole tablet	-

Primary Outcome Measures

Name	Time	Method
Change in Positive And Negative Syndome Scale score	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

Secondary Outcome Measures

Name	Time	Method
Change in regional cerebral blood flow by the SPECT-CT brain	Baseline, 24 weeks	Change frome baseline in regional cerebral blood flow by the SPECT-CT brain with treatment
change in the Monteal Cognitive Assessment scores	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
change in the Global Assessment of Functioning scores	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
Safety evaluation	Baseline,6 weeks, 12 weeks, 24 weeks	Number of events observed in each patient and patients with at least one adverse event