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IntroductionLow and middle-income countries (LMICs) hold the majority of disease burden attributed to major depressive disorder (MDD). Despite this, there remains a substantial gap for access to evidence-based treatments for MDD in LMICs like Pakistan. Measurement-based care (MBC) incorporates systematic administration of validated outcome measures to guide treatment decision making and is considered a low-cost approach to optimise better clinical outcomes for individuals with MDD but there is a paucity of evidence on the efficacy of MBC in LMICs.ObjectivesThis protocol highlights a randomized trial which will include Pakistani outpatients with moderate to severe major depression.MethodsParticipants will be randomised to either MBC (guided by schedule), or standard treatment (guided by clinicians’ judgement), and will be prescribed with paroxetine (10–60mg/day) or mirtazapine (7.5–45mg/day) for 24 weeks. Outcomes will be evaluated by raters blind to study protocol and treatment.ResultsNational Bioethics Committee (NBC) of Pakistan has given full ethics approval. The trial is being conducted and reported as per recommendation of the CONSORT statement for RCTs.ConclusionsWith increasing evidence from high-income settings supporting the effectiveness of MBC for MDD, it is now necessary to explore its feasibility, utility. and efficacy in low-resource settings. The results of the proposed trial could inform the development of a low-cost and scalable approach to efficiently optimise outcomes for individuals with MDD in Pakistan.Disclosure of InterestNone Declared

AimsA worldwide public health concern is major depressive disorder (MDD) with limited availability and access to evidence-based treatment in low- and middle-income countries (LMICs) such as Pakistan. Measurement-based care (MBC) is a low-cost strategy to improve clinical outcomes for people with MDD that involves the systematic administration of validated outcome measures to inform treatment decisions. However, research on MBC's effectiveness in LMICs is scarce. This paper aims to evaluate the feasibility and clinical effectiveness of MBC against standard care for patients with moderate to severe MDD in Pakistan.MethodsThis is a multicenter randomized control trial. Participants (n = 154) of 18 to 65 years of age recruited from psychiatric units of teaching and non-teaching hospitals and primary care settings such as General Physician (GP) clinics and Basic Health Units (BHUs) from 6 cities were randomised to receive MBC (guided by a schedule), or standard treatment (guided by clinicians’ judgement). Patients were prescribed by treating clinicians either with mirtazapine (7.5–45 mg/day) or paroxetine (10–60 mg/day) for a period of 12 weeks. All participants, regardless of their treatment arm, were followed-up till 24 weeks post-randomization and assessed for severity of depression. Side effects were regularly monitored using standard checklist. Outcome assessors were blind to treatment allocation.ResultsThe Pakistani National Bioethics Committee (NBC) has granted complete ethical approval. A total of 15 psychiatrists and 4 General Practitioners (GPs) were approached and invited to participate in the study and consent was given by 9 psychiatrists and 2 GPs. A total of 351 patients were screened against eligibility criteria and 177 were eligible to participate. A total of 154 eligible participants consented (87%) to participate and were recruited and randomized into the trial. A total of 131 randomized participants (85%) completed 24-month follow-up. Only two adverse events were reported during the trial period. Recruitment, retention and safety analysis indicates feasibility of the trial in Pakistani healthcare context. The data are being analyzed for effectiveness outcomes.ConclusionIt is essential to investigate the viability, usefulness, and efficacy of MBC for MDD in low-resource settings due to mounting data from high-income settings confirming its effectiveness. The planned trial's outcomes may help build a scalable, low-cost method for effectively improving outcomes for MDD patients in Pakistan.