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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance ECT | Experimental |
| |
| Aripiprazole | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maintenance ECT | Procedure | Frequency of weekly sessions for 1 month, then fortnightly for 5 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive And Negative Syndome Scale score | Change from baseline in Total, Positive, negative and general scores with treatment. Minimum value: 30; maximum value: 210. Higher score means worsening of symptoms | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in regional cerebral blood flow by the SPECT-CT brain | Change frome baseline in regional cerebral blood flow by the SPECT-CT brain with treatment | Baseline, 24 weeks |
| change in the Monteal Cognitive Assessment scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biswa Ranjan Mishra, MD | Contact | 9438884220 | psych_biswa@aiimsbhubaneswar.edu.in | |
| Debadatta Mohapatra, MD | Contact | psych_debadatta@aiimsbhubaneswar.edu.in |
| Name | Affiliation | Role |
|---|---|---|
| Rituparna Maiti, MD | AIIMS Bhubaneswar | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35049446 | Background | 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. | |
| 28655284 | Background | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Aripiprazole tablet | Drug | Aripiprazole 10 mg in the morning throughout the study period |
|
change from baseline in the Monteal Cognitive Assessment scores with treatment. Minimum Value: 0 Maximum Value: 30: Higher score indicate better cognitive function
| Baseline,6 weeks, 12 weeks, 24 weeks |
| change in the Global Assessment of Functioning scores | change from baseline in the Global Assessment of Functioning scores with treatment Minimum Value: 0 Maximum Value: 100: Higher score indicate better global functioning | Baseline, 6 weeks, 12 weeks, 24 weeks |
| Safety evaluation | Number of events observed in each patient and patients with at least one adverse event | Baseline,6 weeks, 12 weeks, 24 weeks |
| 33454644 | Background | 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. |
| 9137112 | Background | 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. |
| 16633199 | Background | 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. |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |