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Major Depressive Disorder clinical trials

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NCT ID: NCT06306248 Recruiting - Clinical trials for Major Depressive Disorder

Immune Activation, Neural Plasticity and Depression

Start date: March 3, 2023
Phase:
Study type: Observational

Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.Increasing evidence indicates a clear link between immune dysfunction and MDD.Moreover, an activation of inflammatory pathways is associated to a lack of clinical response to antidepressants. Thus, the regulation of inflammation represents a potential approach to modulate the link between the living environment and antidepressant outcome. Light therapy combined with sleep deprivation hastens recovery, with benefits that can be perceived by patients during the first week of treatment. Alteration of the sleep-wake cycle and of sleep structure are core symptoms of MDD.The aims of the present project are (i) to show that neural plasticity and the environmental context are moderating factors of the therapeutic outcome of immune modulation and (ii) to exploit their interplay to set up novel and effective therapeutic strategies for MDD.This is a observational prospective study with non-invasive add-on procedures (Magnetic Resonance without contrast). In this study, 60 patients with a depressive episode in course of MDD and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT), as performed in clinical practice, will be studied. All participants enrolled in the study will receive Treatment As Usual (TAU), i.e., pharmacotherapy, chronobiological intervention plus clinical management. Drug prescription will be performed during the clinical management sessions.The study will have a total duration of 24 months. Each subject will participate in the study for 6 months, will undergo Magnetic Resonance Imaging (MRI) and clinical evaluation at baseline, after one week of chronobiological treatment and at 6 months follow-up.

NCT ID: NCT06306209 Recruiting - Clinical trials for Major Depressive Disorder

Inflammatory Control of Antidepressant Efficacy: a Pharmaco-epigenetic Approach

Start date: May 18, 2021
Phase:
Study type: Observational

Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.It posits that the increase in serotonin levels induced by Selective Serotonin Reuptake Inhibitors (SSRIs) does not affect mood per se, but enhances brain plasticity and thus amplifies the influence of the environment on the individual. Thus, SSRI treatment has not a univocal effect but, in a favorable environment, it would lead to a reduction of symptoms while in a stressful environment might lead to a worse prognosis.Such innovative view opens new perspectives on how to improve SSRI efficacy by controlling the environment. However, often it is not possible to act on the quality of the living environment because of constraints due to patient's personal history and unchangeable life circumstances. In these cases, the pharmacological modulation of the factors underlying the link between living environment and SSRI efficacy represents a novel and desirable strategy to improve treatment outcome even in patients living in adverse conditions, which are very common in depressed patients. Inflammatory levels are markedly affected by the socioeconomic status and thus by the quality of the living environment. The hypothesis of the present project is that inflammation mediates the influence of the environment on SSRI outcome.Therefore, the control of inflammatory levels is a promising strategy to improve treatment efficacy and overcome the limited SSRI efficacy, especially when administered in patients living in adverse conditions. A further hypothesis is that the influence of the environment on inflammation, in turn affecting SSRI efficacy, occurs through epigenetic modifications. Therefore, the project aims at developing a pharmaco-epigenetic approach as effective treatment for MDD. In addition, through neuroimaging investigations, it will provide important information about functional and structural brain modifications associated to SSRI efficacy in patients. Both males and females will be considered because MDD is twice as common in women than men, suggesting that different mechanisms may underlie the psychopathology in the two sexes.

NCT ID: NCT06299787 Recruiting - Clinical trials for Major Depressive Disorder

Cognitive Dysfunction in the Addictions Study - Project 4 (P4)

CDiA-P4
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder.

NCT ID: NCT06293781 Recruiting - Clinical trials for Major Depressive Disorder

Application of the Web-based Acceptance and Commitment Therapy for Depression

ACTION
Start date: December 19, 2022
Phase: N/A
Study type: Interventional

PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY

NCT ID: NCT06271954 Recruiting - Clinical trials for Major Depressive Disorder

The Relationship Between Emotion Regulation and Psychiatric Disorder in Youth

Start date: March 27, 2023
Phase:
Study type: Observational [Patient Registry]

According to the increasing worldwide prevalence rate of psychiatric disorders in youth, the mental health of youth is becoming more and more important. Taiwan's Ministry of Health and Welfare reported the clibing suicide rate of youth in past five years and showed the prevention work and related intervention for youth's mental health was noteable. The definition of emotion regulation was "consists of the extrinsic and intrinsic processes responsible for monitoring, evaluating, and modifying emotional reactions, especially their intensive and temporal features, to accomplish one's goals." Emotion regulation strategies including "rumination", "avoidance", "suppression", "Problem-solving", "reappraisal", "acceptance", "social support", and "distraction". Previous studies had examined the relationship between emotion regulation and mental health in youth; maladaptive emotion regulation would increase the individual's depressive and anxiety symptoms. Carstensen proposed social emotion theory in 1995 Selectivity theory (SST) refers to the need for emotion regulation, which activates Social participation in late adulthood. SST assumes that young people are more interested in social interaction behaviors related to information seeking and building self-concept. characteristics of youth affected by many normative challenges such as adolescence, school transitions, and more complex social Landscape; Adaptive emotion regulation will reduce risk of clinical emotion attacks of illness, especially depression and anxiety.To explore the relationship between emotion regulation and mental health from a psychosocial developmental aspect, we focused on the interaction between individual and environment. Compared with the previous generation, most youths of this generation were participating in social activities and building up interpersonal relationships through the internet, suggesting the internet was an important social context.

NCT ID: NCT06267846 Recruiting - Clinical trials for Major Depressive Disorder

A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder

Start date: March 20, 2024
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).

NCT ID: NCT06254612 Recruiting - Clinical trials for Major Depressive Disorder

A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

Start date: March 25, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.

NCT ID: NCT06252701 Recruiting - Obesity Clinical Trials

Diet and Depression

Start date: April 2024
Phase: N/A
Study type: Interventional

This study is a pilot open label crossover trial to assess the feasibility and acceptability of reducing ultra- processed foods (UPF) in a personalized manner from the diets of patients with major depressive disorder who eat a large percentage of UPF.

NCT ID: NCT06236880 Recruiting - Clinical trials for Major Depressive Disorder

A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD

Start date: January 31, 2024
Phase: Phase 2
Study type: Interventional

The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy.

NCT ID: NCT06235905 Recruiting - Clinical trials for Major Depressive Disorder

Open-Label of SPN-820 in Adults With Major Depressive Disorder

Start date: February 15, 2024
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of SPN-820 in Adults With Major Depressive Disorder (MDD)