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Depressive Disorder, Major clinical trials

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NCT ID: NCT06230757 Not yet recruiting - Clinical trials for Major Depressive Disorder

Psilocybin for Treatment-Resistant Depression

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of psilocybin on the symptom of anhedonia in individuals with treatment-resistant major depressive disorder.

NCT ID: NCT06229652 Not yet recruiting - Clinical trials for Major Depressive Disorder

Stress Management in Depressive Disorder: Resilience Training vs. Yoga: Biological, Epigenetic, and Brain Correlates

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short and long term. In addition to psychological factors, biological parameters will be examined to define biomarkers involved in stress response. In the optional neuroimaging part, the effects of the planned interventions on the structure, metabolism and function of the brain will be investigated. The epigenetic part, which is also optional, will examine the effects of the planned interventions on the histone modifications.

NCT ID: NCT06228391 Not yet recruiting - Clinical trials for Major Depressive Disorder

Ketamine Treatment for PTSD and MDD in TBI

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

The goal of this clinical trial is to examine the use of sedative ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans with mild to moderate traumatic brain injury (TBI). The main questions it aims to answer are: - Efficacy of ketamine to reduce symptoms of depression and/or PTSD - Safety of ketamine to treat depression and/or PTSD in TBI Participants will be randomly assigned to receive either ketamine or midazolam (active placebo) twice a week for 3 weeks. During participation, subjects will be interviewed, have lab tests, and complete rating scales, and questionnaires.

NCT ID: NCT06183359 Not yet recruiting - Clinical trials for Major Depressive Disorder

Self-Identification Program

SIP
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Conduct a pilot, single-center, randomized controlled 2-arm study aimed to evaluate the impact of an in-depth 3rd wave CBT program targeting correct self-identification (3rd level of 3rd wave CBT), compared to a control group receiving an acceptance and commitment therapy (ACT; (1st level of 3rd wave CBT, a well-known psychotherapy). Main judgment criteria : Therapeutic response (reduction ≥ 50% between pre and immediate post-treatment), and rate of relapse at 6 months post-therapy. Secondary objectives: Evaluate psychological processes involved in the reduction of moral pain, diligence, ruminations, suicidal ideas, self-concept and alterations in functioning (mental and social), psychological skills.

NCT ID: NCT06168175 Not yet recruiting - Clinical trials for Major Depressive Disorder

Feasibility of Conducting a Clinical Trial Assessing Efficacy of Lactate as Adjunctive Therapy in Patients With Major Depressive Disorder

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

The goal of this clinical trial is to test the efficacy of lactate (a natural substance) in combination with standard antidepressant treatment, in patients hospitalized for a major depressive episode. The main question[s] it aims to answer are: - does lactate diminishes depression severity when administered in combination with antidepressant ? - is it feasible to test lactate treatment in a large-scale clinical trial ? Participants will receive lactate intravenously daily (20 min infusion) for 5 days during hospitalisation (together with the standard antidepressant treatment). Researchers will compare with a group receiving a placebo instead of lactate to see if lactate has antidepressant effects.

NCT ID: NCT06152705 Not yet recruiting - Depression Clinical Trials

Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

In this triple-blind randomized controlled trial, we ask if targeting intermittent theta burst stimulation (iTBS) based on individual resting state connectivity improves treatment outcomes in major depressive disorder (MDD). For the trial, we will recruit 210 patients with major depressive disorder. Each patient will undergo a 30-40-minute MRI scan, after which they will receive a 6-week standard iTBS treatment. Participants will be randomized to receive iTBS either to the standard neuronavigated target (a technique for treatment location targeting, based on group-average connectivity) or to a personalized connectivity-guided target selected based on individual functional connectivity scans. The main outcome of this trial is response rate as determined by ≥ 50% reduction in Grid HRSD-17 scores. Secondary outcomes include remission rate, change in depression, anxiety and anhedonia symptoms, quality of life, and biological measures of heart rate variability, objective sleep measures and daily activity as a proxy of anhedonia - defined as a reduced ability to experience pleasure.

NCT ID: NCT06136546 Not yet recruiting - Inflammation Clinical Trials

Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.

NCT ID: NCT06132178 Not yet recruiting - Depression Clinical Trials

Psilocybin rTMS for Treatment Resistant Depression

PSILOBSD
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.

NCT ID: NCT06105762 Not yet recruiting - Clinical trials for Major Depressive Disorder

Ketogenic Diet for Depression

KETO-MOOD
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Globally, it's estimated that around 300 million people are affected by depressive illness, and even with access to modern mental health care, long-term recovery is uncommon. Recently, there has been increasing interest in a promising intervention: the ketogenic diet. This diet restricts carbohydrate intake, promoting the breakdown of fats into circulating ketone bodies, which can act as an additional energy source for the brain, potentially reducing its reliance on glucose. While various sources of evidence suggest the potential benefits of the ketogenic diet for individuals with depression, robust clinical studies on its efficacy in depressed patients are lacking. Our goal is to conduct an eight-week, assessor-blinded, randomized controlled trial to investigate the therapeutic effects of a very low-carbohydrate, high-fat ketogenic diet compared to an active comparator diet in individuals with depression.

NCT ID: NCT06093906 Not yet recruiting - Clinical trials for Major Depressive Disorder

Positive Processes and Transition to Health (PATH)

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The R33 will be a randomized controlled trial to replicate changes in the targets (unproductive processing, avoidance, reward deficits) from the R61 phase in a larger sample of 135 participants who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, this study will examine Positive Processes and Transition to Health (PATH)'s impact on stressor-related psychopathology in comparison to Progressive Muscle Relaxation (PMR). In the R33 phase, the investigators will examine changes in target mechanisms predicting improvements in PTSD and depressive symptoms, as well as feasibility and acceptability. Patients will receive 6 sessions of PATH or PMR (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 3, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.