Home » Trials » SLCTR/2026/003
Optimizing Care for Patients with Depression: A Randomized Controlled Trial of Pharmacist Interventions to Enhance Adherence, Outcomes, and Satisfaction in a Tertiary Sri Lankan
-
SLCTR Registration Number
SLCTR/2026/003
Date of Registration
The date of last modification
Jan 28, 2026
Scientific Title of Trial
Optimizing Care for Patients with Depression: A Randomized Controlled Trial of Pharmacist Interventions to Enhance Adherence, Outcomes, and Satisfaction in a Tertiary Sri Lankan
Public Title of Trial
Effect of pharmacist-provided education on medication adherence and treatment outcomes among patients with depression compared with usual care.
Disease or Health Condition(s) Studied
Clinical depression according to ICD-10
Scientific Acronym
Public Acronym
Brief title
Optimising Depression Care with Pharmacist interventions: A Randomised Control Trial
Universal Trial Number
U1111-1329-5604
Any other number(s) assigned to the trial and issuing authority
ERC number: 2025/EC/68
What is the research question being addressed?
Does the integration of a clinical pharmacist into the care of patients diagnosed with depression improve medication adherence, reduce drug-related problems, and enhance clinical and economic outcomes compared to usual care?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Psychiatric wards, and clinic of Teaching Hospital Peradeniya and National hospital Kandy
Randomization: Simple randmaomization through computer-generated random numbers.
Intervention: Participants in the intervention arm will receive a structured, pharmacist-led clinical pharmacy service consisting of the following components: 1. Timing, Duration, and Frequency • At baseline/discharge: o Medication reconciliation o Comprehensive medication counselling • Follow-up visits at 1 month, 3 months, and 6 months: o Review and optimization of medication regimens in collaboration with the medical team o Ongoing counselling and monitoring of adherence and safety 2. Content of the Intervention • Medication reconciliation: Identification and correction of discrepancies across patient medication lists. • Medication counselling: Education on indications, dose, duration, adherence strategies, side effects, and lifestyle considerations using motivational interviewing techniques, and Role Play Counselling Framework (HEADU) etc.
Control group (Pharmaceutical care): Routine pharmacy care including dispensing with minimal counselling.
Inclusion criteria
• Patients diagnosed with clinical depression according to ICD-10 • Patients aged 18 years or older. • Both male and female
Exclusion criteria
• Patients with significant cognitive impairments or communication barriers • Patients participating in other ongoing clinical trials or specific treatment related to depression treatment. • Psychotic or bipolar disorder • Pregnant women
Primary outcome(s)
|
1.
Medication adherence assessed by Medication adherence- Brief Medication Questionnaire |
[ baseline ,1 month ,3 month and 6 month ] |
|
2.
Number of re admissions and suicidal attempts |
[ baseline ,1 month ,3 month and 6 month ] |
Secondary outcome(s)
|
1.
Drug related problems assessed by PCNE Classification for Drug-Related Problems V9.1 (a standardized, hierarchical system for identifying, documenting, and resolving issues in drug therapy) |
[ baseline ,1 month ,3 month and 6 month ] |
|
2.
Severity of depression (assessd by Peradeniya depression scale) , Treatment satisfaction (assessed by WHOQOLBRIFF tool), Patient satisfaction (assessed by Treatment satisfaction questionnaire of medicine (TSQM)), Cost benefit of providing clinical pharmacy service (Study questionnaire related to cost benefit analysis) |
[ baseline ,and 6 month ] |
Target number/sample size
144 (72 per group)
Countries of recruitment
Sri Lanka
Anticipated start date
2026-02-20
Anticipated end date
2027-01-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
N/A
Regulatory approvals
N/A
Status
Approved
Date of Approval
2025-09-23
Approval number
EC/2024/68
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Ethics Review Committee of the Faculty of Medicine, University of Peradeniya |
| Telephone: | |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
K.A.I.U.Peiris
pharmacist
Faculty of Medicine higher degree institute, University of Peradeniya
0776055886
isuriupekshani@gmail.com
Contact Person for Public Queries
Prof. Dewashmika Ariyasinghe
Professor in Psychiatry
Department of Psychiatry, Faculty of Medicine,
University of Peradeniya
0812396000
0718704480
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
Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices) will be shared. Study protocol will be made available once published. Data will be made available following 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 in order to achieve the aims in an approved proposal. Proposals should be directed to principal investigator (isuriupekshani@gmail.com). To gain access, data requestors will need to sign a data access agreement. Data will be provided as deidentified as an excel sheet.
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
