Recurrent major depressive disorder with atypical features

Objectives: To analyse the effectiveness of adding: (i) mindfulness-based cognitive therapy (MBCT) delivered through 8 videoconference group sessions (group MBCT), and (ii) MBCT delivered through a self-help manual and 3 low-intensity group support sessions (beginning, middle, and end of the program) via videoconference (supported MBCT self-help) to treatment as usual (TAU, normally maintenance antidepressant medication), for the treatment of patients with recurrent depression, compared with TAU alone. Furthermore, we will assess the cost-utility of group MBCT vs. supported MBCT self-help vs. TAU alone, identifying potential predictors and moderators of response, and exploring the mechanisms through which the interventions exert effects.
Study design: Multicentre randomised controlled trial, with pre-post, 6- and 12-months follow-ups. Centres: Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat), Hospital Universitario Miguel Servet (Zaragoza), and Hospital del Mar (Barcelona).
Participants: Adult patients (n=300) with recurrent depression and high risk of relapse will be randomly assigned to group MBCT, supported MBCT self-help, or TAU.
Primary outcome: time from randomisation to depressive relapse/recurrence at 12-month follow-up (DSM-5). Secondaries: residual symptoms, well-being, quality of life, costs, and quality-adjusted life years. Process measures: rumination, mindfulness, decentering, affectivity, and self-compassion.
Main statistical analyses: Hazard ratios will be calculated using survival analysis. Secondary outcomes, predictors, and moderators will be tested using regression-based approaches. Incremental cost-utility ratios and mediation path-analyses will be estimated. Acceptability will be evaluated using qualitative methods.

The purpose of this study is to evaluate how well JNJ-89495120 works (anti-depressant effects) and how well it is tolerated as compared to placebo on reducing the symptoms of depression in participants with major depressive disorder (MDD).

DECIDE- Deep phenotyping for clinical inferring response in treatment resistant depression -Study
Building upon the "Biobanking" initiative at the Max Planck Institute of Psychiatry, the present project aims to identify clinically relevant subtypes of treatment-resistant depression (TRD) through Clinical Deep Phenotyping (CDP). According to clinical trials, 30-40% of the patients suffering from TRD benefit from lithium treatment. By collecting multimodal biological and clinical-diagnostic markers, such as structural and functional brain imaging via magnetic resonance imaging (MRI), brain signals from electroencephalography, comprehensive blood tests, assessment of perception and cognition through neuropsychological testing, as well as the evaluation of specific depression symptoms and psychological and other comorbidities using standardized questionnaires, a bio-clinical signature will be identified using multivariate machine learning algorithms as an integration method. This signature aims to predict the response to lithium therapy in TRD. Prospectively, such an algorithm could later personalize the treatment decision of 'lithium administration in TRD'. This concept is in line with the Research Domain Criteria (RDoC) of the National Institute of Mental Health (NIH) and aims to offer lithium therapy as a personalized treatment strategy for TRD. Specifically, this means that the likelihood of treatment response can be estimated before administration based on the results of the present study, thus enabling lithium to be offered specifically to those patients who are likely to benefit from it. The study design is non-interventional, meaning the decision for lithium treatment is made for patients according to clinical routine in accordance with the recommendation of the German National Treatment Guideline (NVL) independent of study enrollment. Study participation does not influence treatment decisions for the patients.