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Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia

ConditionClozapine Resistant Schizophrenia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAll India Institute of Medical Sciences, Bhubaneswar

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • maintenance ECT

    Procedure/Surgery

    Frequency of weekly sessions for 1 month, then fortnightly for 5 months

  • Aripiprazole tablet

    Drug

    Aripiprazole 10 mg in the morning throughout the study period

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Maintenance ECTExperimental treatment 1 intervention
Group B: AripiprazoleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

All India Institute of Medical Sciences, Bhubaneswar

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: