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NCT ID: NCT06319378 Recruiting - MDD Clinical Trials

Cancer Related Major Depression Treated With a Single Dose of Psilocybin

CAPSI
Start date: April 17, 2024
Phase: Phase 2
Study type: Interventional

The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is: The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9) ≥10), >1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives).

NCT ID: NCT06130371 Recruiting - MDD Clinical Trials

Stress, Inflammation and Neuroimaging in Major Depressive Disorder as Compared to Premenstrual Dysphoric Disorder

Start date: January 4, 2024
Phase:
Study type: Observational

Premenstrual dysphoric disorder (PMDD) is a sex-specific depressive disorder where depressive symptom severity drastically changes in relation to menstrual cycle phase. It is characterized by late luteal phase symptoms of affective lability, irritability, depressed mood, and anxiety. A lot remains unclear and further studies are needed in order to improve the understanding of PMDD and to differentiate it from major depressive disorder (MDD). To date, and in contrast to MDD, the neural correlates of PMDD have been sparsely and poorly investigated. The aim of this study is therefore to investigate the neural correlates of PMDD as compared to MDD and to relate them to stress reactivity. Therefore, three groups of naturally cycling women will be investigated and compared, namely (1) women with MDD, (2) women with PMDD, and (3) healthy control women. Stress and HPA axis activity are assumed to play a crucial role in the development of many mental disorders, including MDD. How stress reactivity and HPA axis activity are connected to PMDD still needs to be investigated. Furthermore, the HPA axis can affect or suppress the activity of the hypothalamic-pituitary-gonadal (HPG) axis, which is involved mainly in the reproductive, but also the immune system, making it an important candidate for the investigation of sex-specific differences in stress reactivity. There are sex-specific differences in stress reactivity, but also in the prevalence of stress-related diseases. Women are twice as likely to suffer from depression than men and the first onset of MDD usually peaks during the reproductive years. As to why these differences exist, a recent theory suggests that ovarian hormone fluctuations function as modulators of women's susceptibility to stress and that altered reactivity to stressors during different cycle phases plays a role in the etiology of depressive disorders. This hypothesis extends the Social Signal Transduction Theory of Depression which first and foremost relates depression to inflammation. They postulate a critical role of cytokines for understanding the pathogenesis of depression. Therefore, ovarian hormone fluctuations, but also inflammation in regard to MDD and PMDD and stress reactivity will be investigated in this study.

NCT ID: NCT06095778 Recruiting - Clinical trials for Major Depressive Disorder

rTMS Therapy for Treatment-Resistant Depression With Different Targets Guided by pBFS

Start date: November 6, 2023
Phase: N/A
Study type: Interventional

To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.

NCT ID: NCT05976022 Recruiting - Clinical trials for Major Depressive Disorder

pBFS Guided rTMS Therapy Over Different Targets for Treatment-Resistant Depression

Start date: August 4, 2023
Phase: N/A
Study type: Interventional

To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.

NCT ID: NCT05976009 Recruiting - Clinical trials for Major Depressive Disorder

pBFS-Guided rTMS Therapy Over Different Targets for Treatment-Resistant Depression

Start date: August 29, 2023
Phase: N/A
Study type: Interventional

To explore the effectiveness and safety of rTMS intervention with different targets in the left prefrontal cortex defined using the pBFS method, in adult patients with moderate and severe depressive disorder. Second, investigate the neural circuit that responds to the rTMS intervention using individualized brain image analysis, which may help to establish an effective target for the neuromodulation of patients with major depressive disorder.

NCT ID: NCT05964023 Recruiting - Major Depression Clinical Trials

pBFS Guided VS "5-cm Rule" rTMS Over DLPFC for MDD

Start date: August 20, 2023
Phase: N/A
Study type: Interventional

The investigators aim to investigate whether the intervention effect of pBFS-guided rTMS therapy targeting DLPFC is superior to the intervention effect of the traditional "5 cm-rule" guided rTMS therapy in patients with depressive disorders.

NCT ID: NCT05537285 Recruiting - Anhedonia Clinical Trials

Individualized Neuromodulation for Anhedonic Depression

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This program of research constitutes a three-arm, randomized, placebo-controlled trial testing noninvasive brain stimulation for the treatment of anhedonic depression. This trial is part of a larger, three-site study that will be conducted at UCSD, Stanford University, and Cornell University, with the overarching goals to compare competing interventions tested at each site and to combine data that will allow for the creation of an end-to-end model of anhedonic depression. By doing this, the investigators hope to gain insight and lead to the development of brain-behavior biomarkers to identify who is best suited for the different treatment options tested at each site. An additional exploratory objective is phenotyping anhedonic depression from the acquired measures. Anhedonic patients recruited at UCSD will be randomized to one of three treatment arms to receive different forms of accelerated intermittent theta burst stimulation (aiTBS),a novel form of repetitive transcranial magnetic stimulation (rTMS) that is an FDA approved treatment for depression. These arms include: individualized accelerated iTBS (Ind-aiTBS),based on both the frequency of brain responses and electric-field (e-field) modeling of brain bioconductivity; standard accelerated iTBS (Std-aiTBS); and accelerated sham iTBS(sham). Treatment will be delivered on an accelerated schedule, over one week. Additional study sessions will occur both before and after treatment to assess for clinical, neurophysiological, and cognitive measures that will allow for both individualization of treatment and detailed assessment of the effects of the different treatment arms.

NCT ID: NCT05437588 Recruiting - Depression Clinical Trials

Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.

NCT ID: NCT05169346 Recruiting - MDD Clinical Trials

Neurofeedback to Treat Depression

Start date: May 25, 2022
Phase: N/A
Study type: Interventional

This study tests the efficacy of a new psychotherapeutic strategy for reducing negative attention bias (and therefore depression severity) in participants with MDD (60 in R61 phase and 80 in R33 Phase). This real-time fMRI neurofeedback therapy uses cloud-based pattern classification to decode a patient's attentional state and dynamically modulate task stimuli (in a closed loop) based on this state.

NCT ID: NCT04071886 Recruiting - MDD Clinical Trials

Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the short-term effects of mindfulness-based training in individuals suffering from major depressive disorder (MDD) as assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.