Real-world evidence from a European cohort study of patients with treatment resistant depression: Treatment patterns and clinical outcomes

Heerlein, K.; Perugi, Giulio; Otte, Christian; Frodl, Thomas; Degraeve, G; Hagedoorn, W.; Oliveira‐Maia, Albino J.; Solá, V. Pérez; Rathod, Shanaya; Rosso, Gianluca; Sierra, Pilar; Malynn, S.; Morrens, Joachim; Verrijcken, C.; González, Bernardo; Young, Allan H.

doi:10.1016/j.jad.2021.03.073

Cited by 41 publications

(50 citation statements)

References 34 publications

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“…The poor response and remission rates observed at 6 and 12 months seem to reflect the difficult-to-treat nature of TRD: 71.9% of the patients were still non-responder to the treatment at month 6, with a mean MADRS score of 26.3, indicanting persistence of clinically relevant depressive symptoms. These results were similar to those observed in overall European cohort (34).…”

Section: N = 89supporting

confidence: 91%

“…Available data of 411 TRD patients with moderate-to-severe disease starting a new antidepressant treatment and followed for a minimum 6 months period were analyzed. Results from the overall European cohort showed the substantial impact of TRD on patients and society (33), and underlined the wide range of treatments used in clinical practice and the poor response rates of these patients (34).…”

Section: Introductionmentioning

confidence: 92%

“…Given such negative outcomes, it is surprising that no patient in the Italian cohort was treated with neurostimulatory techniques and that the use of psychotherapy was very limited. In particular, psychosocial therapy was prescribed to 7% of our Italian patients but to 19.2% of patients in the overall Euoropean cohort (34). In a recent Danish study, psychotherapy was used in 18% of TRD patients (39).…”

Section: N = 89mentioning

confidence: 99%

“…In light of this need, a cohort study was established in 2018 to collect real-world data from TRD patients treated in clinical practice in several European countries (33,34). Available data of 411 TRD patients with moderate-to-severe disease starting a new antidepressant treatment and followed for a minimum 6 months period were analyzed.…”

Section: Introductionmentioning

confidence: 99%

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Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study

et al. 2021

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Introduction: Treatment-resistant depression (TRD) is a debilitating condition affecting 20–30% of patients with major depressive disorders (MDD). Currently, there is no established standard of care for TRD, and wide variation in the clinical approach for disease management has been documented. Real-world data could help describe TRD clinical features, disease burden, and treatment outcome and identify a potential unmet medical need.Methods: We analyzed the Italian data from a European, prospective, multicentric, observational cohort study of patients fulfilling TRD criteria by the European Medicine Agency, with moderate to severe major depressive episode, and starting a new antidepressant treatment according to routinary clinical practice. They were followed up for minimum 6 months. Treatments received throughout the study period, disease severity, health-related quality of life and functioning were prospectively recorded and analyzed.Results: The Italian subcohort included 124 TRD patients (30.2% of patients of the European cohort; mean age 53.2 [sd = 9.8], women: 82, 66.1%). At enrollement, the mean (SD) duration of MDD was 16 years (sd = 11.1) and the mean duration of the ongoing major depressive episode (MDE) was 97.5 weeks (sd = 143.5); low scores of quality of life and functioning were reported. The most frequently antidepressant classes started at baseline (data available for 98 subjects) were selective serotonin reuptake inhibitors (SSRI, 42 patients [42.9%]) and serotonin-norepinephrine reuptake inhibitors (SNRI, 32 patients [32.7%]). In terms of treatment strategies, 50 patients (51%) started augmentation therapies, 18 (18.4%) combination therapies and 24 (24.5%) monoterapies (6 patients [6%] started a non-antidepressant drug only). Fourteen patients (11.3%) were treated with a psychosocial approach, including psychotherapy. After 6 months of treatment, clinical assessments were collected for 89 patients: 64 (71.9%) showed no response, 9 (10.1%) response without remission and 16 (18.0%) were in remission; non-responder patients showed lower quality of life and higher disability scores than responder patients.Conclusions: In our sample of TRD patients, we documented substantial illness burden, low perceived quality of life and poor outcome, suggesting an unmet treatment need in TRD care in Italy.Registration Number:ClinicalTrials.gov, number: NCT03373253.

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Section: N = 89supporting

confidence: 91%

Section: Introductionmentioning

confidence: 92%

Section: N = 89mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study

et al. 2021

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“…Major depressive disorder is one of the most common psychiatric illnesses, resulting in enormous personal and socioeconomic burdens 1 . Because the available monoamine‐based antidepressants have major limitations, including a delayed onset of treatment response (weeks to months) and low efficacy (more than one‐third of depressed patients fail to respond to two or more antidepressants and are characterized as having treatment‐resistant depression), 2,3 there is an unmet medical need for more effective and rapid‐acting antidepressants. We previously reported that intracerebroventricular (i.c.v.)…”

Section: Introductionmentioning

confidence: 99%

Resolvin D2 attenuates chronic pain–induced depression‐like behavior in mice

Suzuki

HitoraーImamura

Deyama

et al. 2021

Neuropsychopharm Rep

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Aim We previously demonstrated that intracerebroventricular injection of resolvin D2 (RvD2), a bioactive lipid mediator derived from docosahexaenoic acid, ameliorated depression‐like behavior in lipopolysaccharide‐induced and chronic mild stress–induced mouse models of depression. In the present study, we examined the antidepressant effect of RvD2 on chronic pain–induced depression‐like behavior. Methods To prepare the neuropathic pain model, mice were subjected to surgery for unilateral spared nerve injury. Two weeks after surgery, the antidepressant effect of RvD2 was examined using the tail suspension test. Results Chronic pain significantly increased immobility time, and this depression‐like behavior was attenuated by intracerebroventricular injection of RvD2 (10 ng). No effect of RvD2 on the locomotor activity was observed. Conclusion RvD2 produces an antidepressant effect in a murine model of chronic pain–induced depression and may be a promising lead for the development of novel antidepressants.

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Association of Treatment-Resistant Depression With Patient Outcomes and Health Care Resource Utilization in a Population-Wide Study

et al. 2023

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ImportanceThe totality of the societal and individual impact of treatment-resistant depression (TRD) is unknown, as is the potential to prognosticate TRD. The generalizability of many observational studies on TRD is limited.ObjectiveTo estimate the burden of TRD in a large population-wide cohort in an area with universal health care by including data from both health care types (psychiatric and nonpsychiatric) and, further, to develop a prognostic model for clinical use.Design, Setting, and ParticipantsThis cohort study, a population-based observational study, assessed data from the Stockholm MDD Cohort for episodes of major depressive disorder (MDD) between 2010 and 2017 that fulfilled predefined criteria for TRD (≥3 consecutive antidepressant treatments). Data analysis was performed from August 2020 to May 2022.Main Outcomes and MeasuresOutcomes were psychiatric and nonpsychiatric comorbid conditions, antidepressant treatments, health care resource utilization, lost workdays, all-cause mortality, and intentional self-harm and, in the prognostic model, TRD.ResultsA total of 158 169 unipolar MDD episodes (in 145 577 patients) were identified between January 1, 2012, and December 31, 2017 (64.7% women; median [IQR] age, 42 years [30-56]). Of these, 12 793 episodes (11%) fulfilled criteria for TRD. The median (IQR) time from the start of MDD episode to TRD was 552 days (294-932). Selective serotonin reuptake inhibitor was the most common class of antidepressant treatment in all treatment steps, and 5907 patients (46.2%) received psychotherapy at some point before initiation of the third pharmacological antidepressant treatment. Compared with matched non-TRD episodes, TRD episodes had more inpatient bed-days (mean, 3.9 days; 95% CI, 3.6-4.1, vs 1.3 days; 95% CI, 1.2-1.4) and more lost workdays (mean, 132.3 days; 95% CI, 129.5-135.1, vs 58.7 days; 95% CI, 56.8-60.6) 12 months after the index date. Anxiety, stress, sleep disorder, and substance use disorder were all more common comorbid conditions in TRD episodes. Intentional self-harm was more than 4 times more common in TRD episodes. The all-cause mortality rate for patients with MDD with TRD episodes was 10.7/1000 person-years at risk, compared with 8.7/1000 person-years at risk for patients with MDD without TRD episodes (hazard ratio, 1.23; 95% CI, 1.07-1.41). Median time from start of the first antidepressant treatment to start of the second, and from start of the second antidepressant treatment to start of the third, was 165 and 197 days, respectively. The severity of MDD, defined using the self-rating Montgomery-Åsberg Depression Rating Scale (MADRS-S) at time of MDD diagnosis, was found to be the most important prognostic factor for TRD (C index = 0.69).Conclusions and RelevanceIn this cohort study, TRD was a common variant of MDD when including patients from both health care types, which is associated with a high disease burden for both patients and society. The median time between initiation of new antidepressant treatments was longer than recommended in current treatment guidelines, suggesting room for more structured and timely depression care.

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Real-world evidence from a European cohort study of patients with treatment resistant depression: Treatment patterns and clinical outcomes

Cited by 41 publications

References 34 publications

Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study

Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study

Resolvin D2 attenuates chronic pain–induced depression‐like behavior in mice

Association of Treatment-Resistant Depression With Patient Outcomes and Health Care Resource Utilization in a Population-Wide Study

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