Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole on Psychopathology and Cerebral Perfusion in Clozapine-resistant Schizophrenia: a Randomized, Double-blind Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- maintenance ECT
- Conditions
- Clozapine Resistant Schizophrenia
- Sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Enrollment
- 40
- Primary Endpoint
- Change in Positive And Negative Syndome Scale score
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
BISWA RANJAN MISHRA
Additional Professor, Psychiatry
All India Institute of Medical Sciences, Bhubaneswar
Eligibility Criteria
Inclusion Criteria
- •Patients clinically diagnosed with CRS (currently under clozapine)
- •Patients aged 18-60 years of either sex.
- •LAR giving voluntary written consent for participation in the study
Exclusion Criteria
- •Patient already on ECT or aripiprazole.
- •History of psychoactive substance abuse or dependence.
- •Co-morbid psychiatric, major medical or neurological disorders.
- •History of organicity or significant head injury.
- •Pacemaker or metal in any body part, excluding the mouth. Pregnant and breastfeeding females.
Arms & Interventions
Maintenance ECT
Intervention: maintenance ECT
Aripiprazole
Intervention: Aripiprazole tablet
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change in regional cerebral blood flow by the SPECT-CT brain(Baseline, 24 weeks)
- change in the Monteal Cognitive Assessment scores(Baseline,6 weeks, 12 weeks, 24 weeks)
- change in the Global Assessment of Functioning scores(Baseline, 6 weeks, 12 weeks, 24 weeks)
- Safety evaluation(Baseline,6 weeks, 12 weeks, 24 weeks)