Home » Trials » SLCTR/2019/010


Single-blind randomized control trial to evaluate the effectiveness of electroconvulsive therapy (ECT) in acute schizophrenia

-

SLCTR Registration Number

SLCTR/2019/010


Date of Registration

11 Mar 2019

The date of last modification

Mar 11, 2019



Application Summary


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)


Trial Details


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

  1. Male and female patients aged 18-60 years
  2. Schizophrenia diagnosed by a consultant psychiatrist according to DSM-V criteria
  3. Positive and Negative Syndrome Scale (PANSS) score >75 .
  4. Patients who have not responded adequately to inpatient treatments in medication for 10 days
  5. Patients who remain psychotic and disturbed after 10 days of treatment

Exclusion criteria

  1. Any contraindication for ECT (including medical conditions, raised intracranial pressure etc.)
  2. Patients with prominent mood symptoms
  3. Patients who are either dependent or have harmful use of psychoactive substances (alcohol or illicit drugs)
  4. Patients who are non-compliant with medication
  5. Any contraindication for general anaesthesia (including medical conditions)
  6. The patients who are pregnant and lactating
  7. Patients who do not have the capacity to give informed consent


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

[]

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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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