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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Frequency of weekly sessions for 1 month, then fortnightly for 5 months
Aripiprazole 10 mg in the morning throughout the study period
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
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
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
Time frame: Baseline, 24 weeks
change in the Monteal Cognitive Assessment scores
change from baseline in the Monteal Cognitive Assessment scores with treatment. Minimum Value: 0 Maximum Value: 30: Higher score indicate better cognitive function
Time frame: 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
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
Safety evaluation
Number of events observed in each patient and patients with at least one adverse event
Time frame: Baseline,6 weeks, 12 weeks, 24 weeks
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