CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Clozapine +1 moredrug
Likely dose
Clozapine 12.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03807882
NCT03807882Phase 4Completed
CompareCT.gov

Comparison of Maintenance ECT Versus Clozapine on Psychopathology and Cerebral Hemodynamics in Treatment-resistant Schizophrenia: A Randomized Controlled Trial

All India Institute of Medical Sciences, Bhubaneswar·interventional·Posted Jan 17, 2019·Updated Jun 16, 2021

In Brief

A Phase 4 clinical trial evaluating Bilateral M-ECT and Clozapine for Treatment Resistant Schizophrenia. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Schizophrenia
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 17, 2019
Enrollment StartFeb 1, 2019
Primary CompletionMay 31, 2020
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.5 years ago

Interventions

Bilateral M-ECTother

Following acute treatment with bilateral ECT of 6 sessions over a period of two weeks, Bilateral M-ECT will be administered at a frequency of 1 session/week for one month, then 1 session / 2 weeks for 2 months and then 1 session/month for next 3 months.

Clozapinedrug

Clozapine will be given in accordance with Maudsley guideline: 12.5 mg on the first day, followed by 12.5mg twice daily on the second day, followed by 25mg twice daily for next two days and then increment of 25mg every two days till the target dose of 250-400 mg per day in two divided doses as per tolerability of the patients