Home » Trials » SLCTR/2019/010
Single-blind randomized control trial to evaluate the effectiveness of electroconvulsive therapy (ECT) in acute schizophrenia
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SLCTR Registration Number
SLCTR/2019/010
Date of Registration
The date of last modification
Sep 16, 2020
Scientific Title of Trial
Single-blind randomized control trial to evaluate the effectiveness of electroconvulsive therapy (ECT) in acute schizophrenia
Public Title of Trial
Single-blind randomized control trial identify the effectiveness of electroconvulsive therapy (ECT) for patients with acute schizophrenia
Disease or Health Condition(s) Studied
Acute schizophrenia
Scientific Acronym
None
Public Acronym
None
Brief title
The effectiveness of ECT for Schizophrenia
Universal Trial Number
U1111-1227-5062
Any other number(s) assigned to the trial and issuing authority
P/126/06/2018 (ERC: Kelaniya)
What is the research question being addressed?
What is the effectiveness of add on electroconvulsive therapy (ECT) on the symptom severity and daily functions in patients with acute schizophrenia?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Investigators, Data analysts, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Inpatient psychiatric units of the North Colombo Teaching Hospital Ragama and National Institute of Mental Health, Angoda
Method of Randomization: Block Randomization
Intervention arm: participants will be treated with add on ECT.
The dose of ECT, number and frequency of ECT will be decided by the treating team according to patient’s clinical needs, treatment response, side effects and patient’s preference. In standard regimens, ECT will be delivered bilaterally (bitemporal) and given 2 or 3 times a week. While up to 4-6 ECT treatments may be given the final number of ECT will be decided by the treating team when Positive and Negative Syndrome Scale (PANSS) score is reduced by 50%.
Antipsychotics and other treatment such as benzodiazepines will be continued according to clinical needs. The treating team would change their dose and medication accordingly.
Control arm: Standard Therapy in the form of antipsychotics and other treatment such as benzodiazepines will be continued according to clinical needs The treating team would change their dose and medication accordingly.
Masking: Investigators, Data analysts and Outcome assessors will be blinded to the intervention status.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
To assess the change in mental illness severity using the Positive and Negative Syndrome Scale (PANSS) |
[ Timepoint: weekly during the inpatient period and at week 1 and week 5 after discharge ] |
2.
To assess the effect of illness on the participant’s day-to-day life on the Global Assessment of Functioning Scale (GAF) |
[ Timepoint: weekly during the inpatient period and at week 1 and week 5 after discharge ] |
3.
To assess the change in cognition as determined by the Montreal Cognitive Assessment (MoCA) |
[ Timepoint: weekly during the inpatient period and at week 1 and week 5 after discharge ] |
Secondary outcome(s)
1.
None |
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Target number/sample size
60 (30 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-03-11
Anticipated end date
2019-05-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Sri Lanka Medical Association (Research grant 2018)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2019-01-11
Approval number
P/126/06/2018
Details of Ethics Review Committee
Name: | Ethics Review Committee of the Faculty of Medicine, University of Kelaniya |
Institutional Address: | PO Box 06, Thalagolla Rd, Ragama, Sri Lanka |
Telephone: | +94112961267 |
Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Asiri Rodrigo
Lecturer and Consultant Psychiatrist
Faculty of Medicine, University of Kelaniya, PO Box 06, Thalagolla Road, Ragama, Sri Lanka
Tel: +94-112961115
Mob: +94-777865791
asirir2000@yahoo.com
Contact Person for Public Queries
Thamali Dissanayake
Research Assistant and Speech and Language Therapist
Faculty of Medicine, University of Kelaniya, PO Box 06, Thalagolla Road, Ragama, Sri Lanka
+94-702149280 (Mobile)
Mob: +94-702149280
thamalidissanayake@gmail.com
Primary study sponsor/organization
Sri Lanka Medical Association
No.06, Wijerama Mawatha, Colombo 07, Sri Lanka.
Tel:+94-11269 3324
office@slma.lk
www.slma.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results being reported, will be shared after de-identification (text, tables, figures and appendices). The study protocol will also be shared. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, including for individual participant data meta analysis. Proposals should be directed to asirir2000@yahoo.com or thamalidissanayake@gmail.com. To gain access, data requestors will need to sign a data access agreement.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results