Home » Trials » SLCTR/2025/024
A double-blind randomized controlled trial of the feasibility and acceptability of folic acid supplementation in reducing depression and suicidal behaviour: A pilot study
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SLCTR Registration Number
SLCTR/2025/024
Date of Registration
The date of last modification
Jun 24, 2025
Scientific Title of Trial
A double-blind randomized controlled trial of the feasibility and acceptability of folic acid supplementation in reducing depression and suicidal behaviour: A pilot study
Public Title of Trial
Study on the effects of folic acid compared to placebo in reducing depression and suicidal behavior: A preliminary investigation
Disease or Health Condition(s) Studied
Depression
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1320-1147
Any other number(s) assigned to the trial and issuing authority
This study received ethical clearance from the Ethics Review Committee, Faculty of Medicine, University of Peradeniya, No: 2024/EC/06
What is the research question being addressed?
1) Is folic acid acceptable and feasible when compared to placebo in the treatment of patients with depression and who are already on usual treatment? 2) Is folic acid effective in improving rates of depression, functioning-level and reducing the occurrence of suicidal ideation and suicidal behaviour, in patients diagnosed with depression?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Healthcare providers, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study settings: National Hospital Kandy, Teaching Hospital Peradeniya, Teaching Hospital Kurunegala, District General Hospital Matale 2.
Method of randomization into study arms The assignment to treatment and control groups will be based on a blocked randomization procedure.
Unit of randomization- A block will consist of 6 and 50 such blocks will be created
Method of sequence generation Within the block allocation will be created with the use of a computer-generated blocked randomization process.
Method of allocation concealment To ensure allocation concealment the participants will be assigned by an independent research assistant who will not be a part of the investigating team. Once inclusion and exclusion criteria are applied to consecutive patients, the allocation will be assigned based on a pre prepared set of 6 envelopes with allocation included in. The selected participants will be assigned by the independent research assistant based on the consecutive envelopes.
Intervention - 1mg/day of folic acid. Route: Oral Duration: 01 year Frequency: Daily Control - The control group will be given a placebo, which will contain starch instead of the active ingredient along with the same excipients used to make folic acid tablets. Route: Oral Duration: 01 year Frequency: Daily.
Inclusion criteria
. Males or females aged 18 years or over. · Diagnosed to have depression (diagnosed as per ICD-10 criteria for depression by a consultant psychiatrist or senior registrar in psychiatry) · On treatment in inpatient psychiatry units or being followed up in psychiatry clinics in the respective hospitals · Have experienced suicidal ideation, or one or more episodes of suicidal behaviour within the past year. (will be screened by trained research assistants, for suicidal ideation or suicidal behaviour in the previous year using C-SSRS, at the start of the study) · Fluent in spoken Sinhala or English
Exclusion criteria
·A person who meets any of the following criteria will be excluded from participation in this study: · ·Diagnosed to have bipolar depression. · Allergy to folic acid use in the past, · too severely depressed to participate in interview /give informed consent · currently undergoing folic acid supplementation or receiving high-dose folic acid treatment for deficiency. · Present with the following psychiatric comorbidities: schizophrenia or another primary psychotic disorder, dementia or a substance dependency. · Known history of significant side effects or allergy to folic acid use in the past. · Too severely depressed to participate in interview/give informed consent. · Currently undergoing folic acid supplementation or receiving high-dose folic acid treatment for deficiency.
Primary outcome(s)
|
1.
The acceptability and feasibility of folic acid supplementation in the treatment of patients with depression will be assessed via 2 questionnaires: one for patients and another for healthcare providers. The participants’ questionnaire will assess the acceptability, side effects, and palatability of the new medication. The healthcare providers’ questionnaire will assess the acceptability, practicality, and feasibility of administering this intervention. |
[ 3 months, 6 months, 12 months ] |
Secondary outcome(s)
|
1.
The severity of depression using the Patient Health Questionnaire 9 (PHQ-9) |
[ Baseline, 3 months, 6 months, 12 months ] |
|
2.
Functioning-level is measured by the World Health Organization Disability Assessment Schedule (WHODAS 2.0) |
[ Baseline, 3 months, 6 months, 12 months ] |
|
3.
The suicidal ideation or suicidal behaviour using the Columbia-Suicide Severity Rating Scale (C-SSRS) |
[ Baseline, 3 months, 6 months, 12 months ] |
|
4.
Adherence to medication using the Morisky Green Levine Medication Adherence Scale (MGLS) |
[ 3 months, 6 months, 12 months ] |
Target number/sample size
300 (150 per arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-10-01
Anticipated end date
2026-09-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University Research Grants, University of Peradeniya, Grant No: URG/2024/23/M
Regulatory approvals
Pending
Status
Approved
Date of Approval
2024-09-06
Approval number
2024/EC/06
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya, Sri Lanka. |
| Telephone: | 081 2396361 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Prof. Dewasmika Ariyasinghe
Professor in Psychiatry
Department of Psychiatry, Faculty of Medicine, University of Peradeniya, Sri Lanka.
081 2389445
info.folic@gmail.com
Contact Person for Public Queries
Prof. Thilini Rajapakse
Chair Professor of Psychiatry
Department of Psychiatry, Faculty of Medicine, University of
Peradeniya, Sri Lanka &
South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Sri Lanka.
081 2389445
info.folic@gmail.com
Primary study sponsor/organization
Prof Dewasmika Ariyasinghe,
Co-Principal Investigator
Department of Psychiatry, Faculty of Medicine, University of Peradeniya
dewasmika.ariyasinghe@med.pdn.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
What data will be shared? · All Individual participant data underlying the reported results, including text, tables, figures, and appendices, will be shared after deidentification. What other documents will be available? · The study protocol will be shared. When will the data be available? (start and end dates) · Data will be accessible beginning three months after article publication and will remain available for up to five years. With whom will the data be shared? · Investigators whose proposed use of the data has been approved by an independent review support analyses that align with the aims outlined in the approved proposal. · Interested researchers should direct their proposals to info.folic@gmail.com to request access. · Data requestors will be required to sign a data access agreement before obtaining the data. Committee identified for this purpose will have access. For what types of analyses will the data be shared? · Data will be shared to achieve aims in the approved proposal By what mechanism will the data be available? · Proposals should be directed to (info.folic@gmail.com) to gain access, data requestors will need to sign a data access agreement. Data will be accessible beginning three months after article publication and will remain available for up to five years.
Study protocol available
Yes
Protocol version and date
· Study protocol version: 04 · Date : 06th November 2024
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
