Clinical trial NCT03807882: Comparison of Maintenance ECT Versus Clozapine in Treatment-resistant Schizophrenia
Official title: Comparison of Maintenance ECT Versus Clozapine on Psychopathology and Cerebral Hemodynamics in Treatment-resistant Schizophrenia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Treatment Resistant Schizophrenia
Keywords: M-ECT
Clozapine
Psychopathology
Cerebral perfusion
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will be conducted to compare the efficacy of maintenance ECT (M-ECT) vs Clozapine in treatment resistant schizophrenia (TRS) in terms of change in psychopathology measures and cerebral hemodynamics.

Detailed description: The proposed study is a prospective, randomized clinical trial in patients suffering from treatment-resistant schizophrenia (TRS) and will be conducted in the Department of Psychiatry, AIIMS, Bhubaneswar, over a period of 16 months. Sixty patients with TRS (TRRIP consensus criteria, 2017), fulfilling the inclusion and exclusion criteria will be recruited for the study. Written informed consent will be taken after explaining the objectives and procedure of the study in detail. The detailed history, relevant social-demographic and clinical data will be collected in a structured case record form (CRF). At baseline, PANSS will be administered to determine the severity of positive symptoms, negative symptoms, and general psychopathology, Global assessment of functioning (GAF), and CGI to determine the baseline severity of the illness and improvement with treatment and MoCA to assess change in cognitive impairment. Before starting the treatment, brain SPECT-CT will be done to measure baseline regional brain blood perfusion. The study cohort will be randomized into two treatment groups by computer-generated random numbers, each group comprising 30 patients. One group will receive maintenance ECT (M-ECT) following acute treatment of bilateral ECT of six sessions along with ongoing antipsychotic and the other group will be treated with Clozapine monotherapy. PANSS, GAF, CGI, MoCA will be re-administered at 6 weeks, 3 months, and 6 months follow-up visits to compare the changes within each group and between the groups. Post-treatment SPECT-CT of the brain will be done at the end of 6 months to document changes in the regional cerebral blood perfusion.

Eligibility criteria: Inclusion Criteria:

* Patients clinically diagnosed with treatment-resistant schizophrenia (TRS) (TRRIP consensus criteria).
* Patients aged 18-60 years of either sex.
* Patients giving voluntary written consent for participation in the study

Exclusion Criteria:

* Patient already on Clozapine or ECT.
* 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 part of the body excluding the mouth.
* Pregnant and breastfeeding females.

Primary outcomes:
measure: Change in severity of psychopathology
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in illness severity, and global improvement with treatment
timeFrame: 24 weeks
measure: Change in global functionality
timeFrame: 24 weeks
measure: Change in Cognitive impairment
timeFrame: 24 weeks
measure: Number of patients receiving rescue medications.
timeFrame: 24 weeks
measure: Change in regional cerebral blood flow
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: Dept of Psychiatry, Aiims, Bhubaneswar
state: Odisha
Study officials:
affiliation: AIIMS Bhubaneswar
name: RITUPARNA MAITI, M.D
role: STUDY_CHAIR
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