Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia
NCT06501339 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-07-16
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.
Conditions
- Clozapine Resistant Schizophrenia
Interventions
- PROCEDURE
-
maintenance ECT
Frequency of weekly sessions for 1 month, then fortnightly for 5 months
- DRUG
-
Aripiprazole tablet
Aripiprazole 10 mg in the morning throughout the study period
Sponsors & Collaborators
-
All India Institute of Medical Sciences, Bhubaneswar
lead OTHER
Principal Investigators
-
Rituparna Maiti, MD · AIIMS Bhubaneswar
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-10
- Primary Completion
- 2025-10-31
- Completion
- 2026-03-31
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