Clinical Research Directory

Disentangling Pharmacological and Expectation Effects in Antidepressant Discontinuation

Antidepressant medication is established as an evidence-based, guideline-recommended treatment for Major Depressive Disorders. In the past decades, prescriptions of antidepressant medication have markedly increased, with a specific surge in maintenance prescriptions and therefore, long-term intake, despite guideline recommendations to discontinue antidepressant medication after maintenance therapy has been completed. Over half of fully remitted patients who attempt to discontinue their antidepressant medication report adverse discontinuation symptoms. For many patients, discontinuation symptoms are so severe, that they do not manage to complete their discontinuation attempt. While discontinuation symptoms, deterioration of depressive symptoms, and recurrence can result from pharmacological effects of antidepressant discontinuation, patients' expectations towards discontinuation are likely to play an essential role in occurrence, too. The aim of the present study is to explore the interplay of expectations and pharmacological effects in antidepressant discontinuation. Participants who fulfill German national S3 guideline recommendations will receive a 1:1 chance to either discontinue their antidepressant medication or remain on their antidepressant medication. In addition, participants' expectations are intended to be manipulated by varying verbal instructions using the open-hidden paradigm. Within the open trial arms, participants will receive full information about their treatment (i.e., high expectation). Within the hidden trial arms, participants will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation). Participants will have a 1:1:1:1 chance of being allocated to 1 of the 4 experimental groups: open discontinuation (OD), hidden discontinuation (HD), open continuation (OC), or hidden continuation (HC) of their antidepressant medication. This preregistration is part of the collaborative research center (CRC) SFB/TRR289 which aims to characterize the psychological and neurobiological effects of treatment expectations on health outcome (https://treatment-expectation.de) and is funded by the Deutsche Forschungsgemeinschaft (DFG).

Deprescription of Antidepressants in Primary Care (DAPriCare)

Introduction The consumption of antidepressants has increased considerably worldwide, including in Spain. Despite their effectiveness in cases of moderate to severe depression, their long-term use in mild cases is questioned. This study aims to evaluate the effectiveness of a deprescribing intervention in primary care, to reduce the unnecessary consumption of these drugs and improve patients' quality of life. Material and Methods A community-based clinical trial will be carried out before and after in an adult population of residents of an urban area of Cadiz (Spain) who have been prescribed antidepressants in the last year. Participants will be randomly selected and followed up for a predetermined period after consensus. The intervention will consist of a comprehensive evaluation of antidepressant treatment by a team of health professionals. Factors such as indication, dose, and response to treatment will be evaluated, and the Hamilton scale for anxiety and the Beck Inventory for depression will be used. In those cases where it is considered appropriate, a gradual reduction or suspension of the drug will be proposed, always under medical supervision. Conclusions This research will contribute to generating scientific evidence on the safety and efficacy of deprescribing in primary care, promoting a more rational use of antidepressants, and improving the quality of life of patients. The results obtained could have important implications for clinical practice and for the development of clinical practice guidelines.

Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants

Objectives: To identify in patients with major depression different peripheral markers of neuroinflammation in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and its relationship with the response to antidepressant treatment with selective serotonin reuptake inhibitors (SSRIs). Methodology: This is a prospective observational cohort study in patients with major depression naturally subjected to treatment with SSRIs. For this, 30 patients with major depression attended in the Outpatient Psychiatry Consultations will be selected. All of them will be evaluated at baseline and after 3 months of treatment, collecting demographic and clinical variables, Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) psychiatric diagnoses, psychopathological scales and immunological and biochemical variables. The correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation with treatment, will be analyzed. A group of 20 healthy subjects will be used as a control group. Subsequently, a bivariate comparative analysis will be carried out, where the statistically significant or marginally significant variables associated with psychopathological variables will be used to build a multivariate binary logistic regression model.