Digital tools for the assessment of pharmacological treatment for depressive disorder: State of the art.

Depression is an invalidating disorder, marked by phenotypic heterogeneity. Clinical assessments for treatment adjustments and data-collection for pharmacological research often rely on subjective representations of functioning. Better phenotyping through digital applications may add unseen information and facilitate disentangling the clinical characteristics and impact of depression and its pharmacological treatment in everyday life. Researchers, physicians, and patients benefit from well-understood digital phenotyping approaches to assess the treatment efficacy and side-effects. This review discusses the current possibilities and pitfalls of wearables and technology for the assessment of the pharmacological treatment of depression. Their applications in the whole spectrum of treatment for depression, including diagnosis, treatment of an episode, and monitoring of relapse risk and prevention are discussed. Multiple aspects are to be considered, including concerns that come with collecting sensitive data and health recordings. Also, privacy and trust are addressed. Available applications range from questionnaire-like apps to objective assessment of behavioural patterns and promises in handling suicidality. Nonetheless, interpretation and integration of this high-resolution information with other phenotyping levels, remains challenging. This review provides a state-of-the-art description of wearables and technology in digital phenotyping for monitoring pharmacological treatment in depression, focusing on the challenges and opportunities of its application in clinical trials and research.

Efficacy and safety of EMA401 in peripheral neuropathic pain: results of 2 randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy.

ABSTRACT: The analgesic efficacy and safety of 2 phase 2b studies of EMA401 (a highly selective angiotensin II type 2 receptor antagonist) in patients with postherpetic neuralgia (EMPHENE) and painful diabetic neuropathy (EMPADINE) were reported. These were multicentre, randomised, double-blind treatment studies conducted in participants with postherpetic neuralgia or type I/II diabetes mellitus with painful distal symmetrical sensorimotor neuropathy. Participants were randomised 1:1:1 to either placebo, EMA401 25 mg, or 100 mg twice daily (b.i.d) in the EMPHENE and 1:1 to placebo or EMA401 100 mg b.i.d. in the EMPADINE. The primary outcome for both the studies was change in weekly mean of the 24-hour average pain score, using a numeric rating scale from baseline to week 12. Both the studies were prematurely terminated due to preclinical hepatotoxicity on long-term dosing, although not observed in these studies. Out of the planned participants, a total of 129/360 (EMPHENE) and 137/400 (EMPADINE) participants were enrolled. The least square mean reduction in numeric rating scale pain score was numerically in favour of EMA401 100 mg arm in both EMPHENE (treatment difference: -0.5 [95% confidence interval: -1.6 to 0.6; P value: 0.35]) and EMPADINE (treatment difference: -0.6 [95% confidence interval: -1.4 to 0.1; P value: 0.10]) at the end of week 12. However, as the studies were terminated prematurely, no firm conclusion could be drawn but the consistent clinical improvement in pain intensity reduction across these 2 studies in 2 different populations is worth noting.