Husain Muhammad Ishrat, Nigah Zahra, Ansari Sami Ul Haque, Khoso Ameer B, Kiran Tayyeba, Umer Madeha, Ansari Moin A, Bhatia Moti Ram, Khan Sylvia A, Husain Muhammad Omair, Malik Abdul Ghafoor, Naqvi Haider Ali, Qadir Altaf, Rajput Aatir H, Saqib Mohsin, Ilyas Muhammad, Doutani Mujeeb Ullah Khan, Sherzad Silsila, Siddiqui K M Sajjad, Tahir Zona, Wang Wei, Husain Nusrat, Chaudhry Nasim, Chaudhry Imran Bashir, Mulsant Benoit H
Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
JAMA Netw Open. 2025 Sep 2;8(9):e2529427. doi: 10.1001/jamanetworkopen.2025.29427.
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.
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.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT05431374.
基于测量的护理（MBC）通过对症状和不良反应进行结构化监测来指导临床决策。尽管MBC已被证明与改善重度抑郁症（MDD）的治疗效果相关，但其在低收入和中等收入国家（LMICs）的有效性仍有待充分研究。
评估在巴基斯坦，与标准护理相比，MBC是否能加速成年MDD患者抑郁症状的缓解。
设计、设置和参与者：这项多中心、评估者盲法、平行组随机临床试验于2022年9月至2024年1月在巴基斯坦进行，随访期为24周。从巴基斯坦7个城市（卡拉奇、拉合尔、拉瓦尔品第、海得拉巴、白沙瓦、木尔坦和奎达）的精神病医院和初级保健中心招募被诊断为非精神病性MDD的成年人。参与者被1:1随机分配到MBC组或标准护理组。进行意向性治疗分析。
按照设计，MBC组和标准护理组的药物治疗均限于帕罗西汀或米氮平。MBC组在每次就诊（基线以及第2、4、8、12和24周）时完成16项抑郁症状快速自评量表和副作用频率、强度及负担评定量表。这些工具的评分结果为抗抑郁药剂量调整或换药提供依据。标准护理组根据临床医生的判断进行治疗，不进行重复的临床测量。
主要结局为在24周随访期内达到缓解的时间（定义为17项汉密尔顿抑郁量表[HDRS-17]评分降低≥50%；范围：0-52，分数越高表明抑郁越严重）和达到临床治愈的时间（定义为HDRS-17评分≤7）。次要结局包括HDRS-17评分的变化以及不良反应或停药率。
共有154名成年人（平均[标准差]年龄，34.5[10.5]岁；105名女性[68.2%]）被随机分组。MBC组达到缓解的中位（四分位间距）时间比标准护理组更快（2[2-4]周对4[2-12]周）；同样，MBC组达到临床治愈的中位（四分位间距）时间也比标准护理组更快（4[4-8]周对8周[2周至未临床治愈]）。在第24周时，两组之间的缓解率或临床治愈率没有显著差异。在第24周后，MBC组的平均HDRS-17评分降低幅度显著但适度大于标准护理组（-18.1[95%置信区间，16.4-19.6]分对-17.0[95%置信区间，15.6-18.5]分；t129 = 0.71；P <.001）。在其他次要结局方面未观察到差异。
这项针对成年MDD患者的试验发现，在资源匮乏的环境中，MBC组比标准护理组达到缓解和临床治愈的时间更快。未来的研究需要证实MBC的临床有效性，并评估其在低收入和中等收入国家的成本效益。
ClinicalTrials.gov标识符：NCT05431374。
