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

1. Compared to standard care, measurement-based care resulted in faster time to response and time to remission among adults with major depressive disorder in Pakistan.

Evidence Rating Level: 1 (Excellent)

Study Rundown: The incidence of major depressive disorder (MDD) is increasing globally, with higher prevalence in low- and middle-income (LMICs) than high-income countries (HICs). Although HICs have access to effective pharmacotherapy and psychotherapy, only a third of patients with MDD achieve remission, mainly attributed to inadequate antidepressant dose and duration of treatment trials. One proposed solution is measurement-based care (MBC), an approach to antidepressant treatment that uses regular monitoring and validated clinical instruments to guide treatment decisions. MBC has been shown to be effective for managing MDD in HICs, but evidence of its effectiveness in LMICs is limited. This study thus compared MBC vs standard care for MDD management in an LMIC.

This randomized clinical trial included adults aged 18-65 years with nonpsychotic MDD recruited from hospitals across Pakistan. Participants were randomized 1:1 to MBC or standard care and followed up for 24 weeks. The primary outcomes were time to response (≥50% reduction in the 17-item Hamilton Depression Rating Scale [HDRS-17]) and time to remission (HDRS-17 score of ≤7) within 24 weeks. The MBC group completed various clinical instruments with resulting scores used to guide antidepressant dose adjustments or switches. The standard care group were treated according to clinician judgment without repeated use of clinical measurements. Out of the 154 adults included in the study, 76 were in the MBC group and 78 in the standard care group. Median time to response and median time to remission were both faster in the MBC group than in the standard care group. At week 24, no differences in rates of response or remission were observed between groups. After week 24, the MBC group showed a modestly greater reduction in mean HDRS-17 scores compared to the standard care group.

Overall, this study found that among patients with MDD in Pakistan, MBC accelerated the time to response and time to remission compared with standard care, highlighting its potential in improving mental health care in LMICs.

Click to read the study in JAMA Network Open  

Relevant reading: Measurement-Based Care Versus Standard Care for Major Depression: A Randomized Controlled Trial With Blind Raters

In-Depth [Randomized controlled trial]: 

This multicenter, assessor-blinded, parallel-arm randomized clinical trial was conducted in Pakistan between September 2022 and January 2024. Adults aged 18-65 years diagnosed with nonpsychotic MDD were recruited from psychiatric hospitals and primary care centers in 7 Pakistani cities. Participants were randomized 1:1 to the MBC or standard care group. In both groups, antidepressants were limited to paroxetine (10mg) or mirtazapine (15mg) per day, each corresponding to 50mg amitriptyline equivalents. All patients were followed up for 24 weeks after randomization, with assessments at baseline and weeks 2, 4, 8, 12, and 24. At each visit, 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, with scores used to guide antidepressant dose adjustments or switches. The standard care group received routine care from their local medical doctor, psychiatrist, or general practitioner based on clinician judgment without repeated use of clinical measurements. Primary outcomes were time to response, defined as ≥50% reduction in the 17-item Hamilton Depression Rating Scale (HDRS-17; range 0-52, with higher scores indicating greater severity), and time to remission, defined as HDRS-17 score of ≤7, within the 24-week follow-up period.

Of the 154 adults in the study (mean [SD] age, 34.5 [10.5] years; 105 females [68.2%]), 76 were in the MBC group and 78 in the standard care group. Compared to the standard care group, the MBC group showed faster median (IQR) time to response (2 [2-4] weeks vs 4 [2-12] weeks) and median (IQR) time to remission (4 [4-8] weeks vs 8 [2 weeks to no remission] weeks). At week 24, no differences in rates of response or remission were observed between groups. After week 24, the MBC group showed a modestly greater reduction in mean HDRS-17 scores compared to the standard care group (−18.1 [95% CI, 16.4-19.6] points vs −17.0 [95% CI, 15.6-18.5] points). No differences were observed in rates of adverse effects or treatment discontinuation. Overall, this study found that MBC accelerated the time to response and time to remission compared with standard care among patients with MDD in Pakistan. These findings highlight the potential of MBC to improve mental health care in LMICs, where mental health resources are often limited. This study had several limitations, including the use of antidepressants not commonly prescribed in Pakistan, a sample size calculated based on expected remission rate rather than time to response and time to remission, and the highly structured nature of RCTs, which may not be reflective of clinical conditions and may have limited external validity. Future research should confirm the study findings in other LMICs while addressing these limitations. 

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