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

Last updated: July 15, 2024
Sponsor: All India Institute of Medical Sciences, Bhubaneswar
Overall Status: Active - Not Recruiting

Phase

4

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Mood Disorders

Treatment

Aripiprazole tablet

maintenance ECT

Clinical Study ID

NCT06501339
T/EMF/Psych/23-24/13
  • Ages 18-60
  • All Genders

Study 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

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

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 breastfeedingfemales.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Aripiprazole tablet
Phase: 4
Study Start date:
August 10, 2024
Estimated Completion Date:
March 31, 2026