Depression
Conditions
Interventions
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 tre
Sponsors
Prof Dewasmika Ariyasinghe,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The severity of depression using the Patient Health Questionnaire 9 (PHQ-9) [Baseline, 3 months, 6 months, 12 months] Functioning-level is measured by the World Health Organization Disability Assessment Schedule (WHODAS 2.0) [Baseline, 3 months, 6 months, 12 months] The suicidal ideation or suicidal behaviour using the Columbia-Suicide Severity Rating Scale (C-SSRS) [Baseline, 3 months, 6 months, 12 months] Adherence to medication using the Morisky Green Levine Medication Adherence Scale (MGLS) [3 months, 6 months, 12 months] | — |
Countries
Sri Lanka
Contacts
Public ContactProf. Dewasmika Ariyasinghe
Professor in Psychiatry
Outcome results
None listed