Clinical trial NCT06501339: Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia
Official title: Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole on Psychopathology and Cerebral Perfusion in Clozapine-resistant Schizophrenia: a Randomized, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Clozapine Resistant Schizophrenia
Keywords: Clozapine resistant
schizophrenia
Aripiprazole
m-ECT
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Positive And Negative Syndome Scale score
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
Secondary outcomes:
measure: Change in regional cerebral blood flow by the SPECT-CT brain
timeFrame: Baseline, 24 weeks
measure: change in the Monteal Cognitive Assessment scores
timeFrame: Baseline,6 weeks, 12 weeks, 24 weeks
measure: change in the Global Assessment of Functioning scores
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks
measure: Safety evaluation
timeFrame: Baseline,6 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AIIMS Bhubaneswar
name: Rituparna Maiti, MD
role: STUDY_DIRECTOR
References:
citation: Siskind D, Orr S, Sinha S, Yu O, Brijball B, Warren N, MacCabe JH, Smart SE, Kisely S. Rates of treatment-resistant schizophrenia from first-episode cohorts: systematic review and meta-analysis. Br J Psychiatry. 2022 Mar;220(3):115-120. doi: 10.1192/bjp.2021.61.
citation: Siskind D, Siskind V, Kisely S. Clozapine Response Rates among People with Treatment-Resistant Schizophrenia: Data from a Systematic Review and Meta-Analysis. Can J Psychiatry. 2017 Nov;62(11):772-777. doi: 10.1177/0706743717718167. Epub 2017 Jun 28.
citation: Campana M, Falkai P, Siskind D, Hasan A, Wagner E. Characteristics and definitions of ultra-treatment-resistant schizophrenia - A systematic review and meta-analysis. Schizophr Res. 2021 Feb;228:218-226. doi: 10.1016/j.schres.2020.12.002. Epub 2021 Jan 14.
citation: Rey JM, Walter G. Half a century of ECT use in young people. Am J Psychiatry. 1997 May;154(5):595-602. doi: 10.1176/ajp.154.5.595.
citation: Chanpattana W, Andrade C. ECT for treatment-resistant schizophrenia: a response from the far East to the UK. NICE report. J ECT. 2006 Mar;22(1):4-12. doi: 10.1097/00124509-200603000-00002.