Measurement-Based Care to Enhance Antidepressant Treatment Outcomes in Major Depressive Disorder: A Randomized Clinical Trial.

Importance: Measurement-based care (MBC) guides clinical decisions through structured monitoring of symptoms and adverse effects. Although MBC has been associated with improved outcomes in major depressive disorder (MDD), its effectiveness in low- and middle-income countries (LMICs) remains understudied.

Objective: To assess whether MBC accelerates the resolution of depressive symptoms compared with standard care among adults with MDD in Pakistan.

Design, Setting, And Participants: This multicenter, assessor-blinded, parallel-arm randomized clinical trial was conducted in Pakistan from September 2022 to January 2024, with 24 weeks of follow-up. Adults diagnosed with nonpsychotic MDD were recruited from psychiatric hospitals and primary care centers in 7 Pakistani cities (Karachi, Lahore, Rawalpindi, Hyderabad, Peshawar, Multan, and Quetta). Participants were randomized 1:1 to MBC or standard care. Intention-to-treat analyses were conducted.

Interventions: By design, pharmacotherapy was limited to paroxetine or mirtazapine in both MBC or standard care groups. The MBC group completed the 16-item Quick Inventory of Depressive Symptomatology-Self-Report and the Frequency, Intensity, and Burden of Side Effects Rating Scale at each visit (baseline and weeks 2, 4, 8, 12, and 24). Scores from these instruments informed antidepressant dose adjustments or switch. The standard care group received treatment based on clinician judgment and did not undergo repeated clinical measurements.

Main Outcomes And Measures: Primary outcomes were time to response (defined as ≥50% reduction in the 17-item Hamilton Depression Rating Scale [HDRS-17]; range: 0-52, with the highest score indicating severe depression) and time to remission (defined as HDRS-17 score of ≤7) within the 24-week follow-up period. Secondary outcomes included changes in HDRS-17 scores and rates of adverse effects or treatment discontinuation.

Results: A total of 154 adults (mean [SD] age, 34.5 [10.5] years; 105 females [68.2%]) were randomized. Median (IQR) time to response was faster with MBC than with standard care (2 [2-4] weeks vs 4 [2-12] weeks); similarly, median (IQR) time to remission was faster for MBC vs standard care (4 [4-8] weeks vs 8 weeks [2 weeks to no remission] weeks). At week 24, there were no significant differences in rates of response or remission between groups. After week 24, reduction in mean HDRS-17 scores was significantly but modestly greater in the MBC group than in the standard care group (-18.1 [95% CI, 16.4-19.6] points vs -17.0 [95% CI, 15.6-18.5] points; t129 = 0.71; P < .001). No differences were observed in other secondary outcomes.

Conclusions And Relevance: This trial of adults with MDD found that MBC led to faster time to response and time to remission than standard care in low-resource settings. Future studies need to confirm the clinical effectiveness of MBC and assess its cost-effectiveness in LMICs.

Trial Registration: ClinicalTrials.gov Identifier: NCT05431374.