Comparison of Maintenance ECT Versus Clozapine in Treatment-resistant Schizophrenia
Condition: Treatment Resistant Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Bilateral M-ECT; Clozapine
Intervention type(s): Other; Drug
Intervention description(s): 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.; 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
Intervention MeSH terms: Clozapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: M-ECT; Clozapine; Psychopathology; Cerebral perfusion