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NCT Number: NCT06501339

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

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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Key information

Conditions

Clozapine Resistant Schizophrenia Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

maintenance ECT

Procedure

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

Primary outcomes

  1. 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

  1. Change in regional cerebral blood flow by the SPECT-CT brain

    Time frame: Baseline, 24 weeks

    Change frome baseline in regional cerebral blood flow by the SPECT-CT brain with treatment

  2. change in the Monteal Cognitive Assessment scores

    Time frame: Baseline,6 weeks, 12 weeks, 24 weeks

    change from baseline in the Monteal Cognitive Assessment scores with treatment. Minimum Value: 0 Maximum Value: 30: Higher score indicate better cognitive function

  3. change in the Global Assessment of Functioning scores

    Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks

    change from baseline in the Global Assessment of Functioning scores with treatment Minimum Value: 0 Maximum Value: 100: Higher score indicate better global functioning

  4. Safety evaluation

    Time frame: Baseline,6 weeks, 12 weeks, 24 weeks

    Number of events observed in each patient and patients with at least one adverse event

Study contacts

Contact information is provided by the study sponsor or research team.

Biswa Ranjan Mishra, MD

CONTACT

[email protected]

9438884220

Debadatta Mohapatra, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole on Psychopathology and Cerebral Perfusion in Clozapine-resistant Schizophrenia: a Randomized, Double-blind Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 15, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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