Are We Measuring What Matters in Postpartum Depression Trials?
Author(s)
Yuen May Toh, MSc1, Caroline Solon, MSc2.
1Senior Analyst, Avalere Health, London, United Kingdom, 2Avalere Health, Sausalito, CA, USA.
1Senior Analyst, Avalere Health, London, United Kingdom, 2Avalere Health, Sausalito, CA, USA.
OBJECTIVES: Postpartum depression (PPD) has a distinct symptom profile from major depressive disorder (MDD), with less prominent sad mood and more frequent psychomotor disturbances and cognitive impairments. This study aimed to identify quality of life (QoL) instruments used in PPD clinical trials and assess their adequacy in capturing its patient impact.
METHODS: A targeted search of ClinicalTrials.gov identified Phase 2-4 interventional trials of pharmacologic treatments for PPD with primary completion dates from 2015 onward. Studies were included if both primary and secondary endpoints assessed symptoms. QoL instrument components were then compared to PPD-relevant symptoms to evaluate overlap.
RESULTS: Of n=66 studies identified that assessed therapeutic interventions for PPD, n=13 (n=9 Phase 2 and n=4 Phase 3 trials) met inclusion criteria. Seven instruments were used to measure primary and secondary endpoints. The Hamilton Rating Scale for Depression (HAM-D) was most frequently used, appearing in n=10 studies to assess symptoms such as mood disturbance, guilt, and suicidal ideation. The Montgomery-Åsberg Depression Rating Scale (MADRS) and Beck Depression Inventory (BDI) were used as primary outcome measures in n=3 and n=2 studies, respectively. Only one study used the Parenting Stress Index (PSI), a tool for assessing caregiving-related stress, an outcome relevant to PPD as a secondary endpoint. Although originally developed as a screening tool for PPD, the Edinburgh Postnatal Depression Scale (EPDS) was also used as a secondary outcome measure to assess treatment efficacy in n=7 clinical trials. However, it omitted several symptoms including weight changes, low energy, and altered self-perception that were more prevalent in PPD than MDD.
CONCLUSIONS: Most PRO instruments were developed for MDD and lack sensitivity to PPD’s distinct symptom profile—especially with comorbid anxiety, which compromises maternal QoL, functioning, and family dynamics. Non-specific tools risk undervaluing emerging therapies, highlighting the need to develop PPD-specific tools for accurate value assessment.
METHODS: A targeted search of ClinicalTrials.gov identified Phase 2-4 interventional trials of pharmacologic treatments for PPD with primary completion dates from 2015 onward. Studies were included if both primary and secondary endpoints assessed symptoms. QoL instrument components were then compared to PPD-relevant symptoms to evaluate overlap.
RESULTS: Of n=66 studies identified that assessed therapeutic interventions for PPD, n=13 (n=9 Phase 2 and n=4 Phase 3 trials) met inclusion criteria. Seven instruments were used to measure primary and secondary endpoints. The Hamilton Rating Scale for Depression (HAM-D) was most frequently used, appearing in n=10 studies to assess symptoms such as mood disturbance, guilt, and suicidal ideation. The Montgomery-Åsberg Depression Rating Scale (MADRS) and Beck Depression Inventory (BDI) were used as primary outcome measures in n=3 and n=2 studies, respectively. Only one study used the Parenting Stress Index (PSI), a tool for assessing caregiving-related stress, an outcome relevant to PPD as a secondary endpoint. Although originally developed as a screening tool for PPD, the Edinburgh Postnatal Depression Scale (EPDS) was also used as a secondary outcome measure to assess treatment efficacy in n=7 clinical trials. However, it omitted several symptoms including weight changes, low energy, and altered self-perception that were more prevalent in PPD than MDD.
CONCLUSIONS: Most PRO instruments were developed for MDD and lack sensitivity to PPD’s distinct symptom profile—especially with comorbid anxiety, which compromises maternal QoL, functioning, and family dynamics. Non-specific tools risk undervaluing emerging therapies, highlighting the need to develop PPD-specific tools for accurate value assessment.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR19
Topic
Epidemiology & Public Health, Patient-Centered Research, Study Approaches
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Mental Health (including addition)