Clozapine Resistant Schizophrenia
Conditions
Keywords
Clozapine resistant, schizophrenia, Aripiprazole, m-ECT
Brief 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.
Interventions
PROCEDUREmaintenance ECT
Frequency of weekly sessions for 1 month, then fortnightly for 5 months
Aripiprazole 10 mg in the morning throughout the study period
Sponsors
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 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 breastfeeding females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive And Negative Syndome Scale score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in regional cerebral blood flow by the SPECT-CT brain | Baseline, 24 weeks | Change frome baseline in regional cerebral blood flow by the SPECT-CT brain with treatment |
| change in the Monteal Cognitive Assessment scores | 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 |
| change in the Global Assessment of Functioning scores | 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 |
| Safety evaluation | Baseline,6 weeks, 12 weeks, 24 weeks | Number of events observed in each patient and patients with at least one adverse event |
Contacts
Primary ContactBiswa Ranjan Mishra, MD
Backup ContactDebadatta Mohapatra, MD
Outcome results
None listed