Brain Markers of Depression Vulnerability: the Case of Prefrontal Haemodynamic Response
Functional near infrared spectroscopy (fNIRS) offers a cheap and reliable tool to investigate prefrontal brain activation in the healthy and diseased human brain. As such, fNIRS bears great potential as a diagnostic tool for clinical practice. Research indicates that fNIRS, together with a relatively simple task to activate the prefrontal cortex, the so-called verbal fluency task (VFT), elucidates prefrontal dysfunction in major depressive disorder (MDD). This finding can potentially serve as an imaging marker for disease pathology, even when depressive symptoms are absent. Indeed, recent research also suggests prefrontal dysfunction in fully remitted MDD (rMDD). Prefrontal haemodynamic responses may therefore serve as a trait marker for MDD vulnerability. This study aims to investigate the haemodynamic response in rMDD, healthy participants with increased MDD risk (HCr; having a 1st-degree relative with MDD), and low-risk healthy participants (HCnr; having no 1st-degree relatives with MDD) using fNIRS. The investigators hypothesize lower prefrontal reactivity in HCr compared to HCnr, and lowest prefrontal reactivity in rMDD compared to HCnr. This study has the potential to elucidate the neuronal underpinnings of depression vulnerability in the absence of symptoms that are sometimes considered a confounding factor when it comes to studying the biological encoding of depression.
NCT05427578 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05427578/
ADEPT: Adaptive Trial for the Treatment of Depressive Symptoms Associated With Concussion Using Repetitive Transcranial Magnetic Stimulation Protocols
The purpose of this study is to investigate the efficacy, safety, and tolerability of two dorsolateral prefrontal cortex (DLPFC) repetitive transcranial magnetic stimulation (rTMS) protocols to alleviate symptoms of depression in United States (U.S.) military service members and veterans with a history of concussion/mild traumatic brain injury (TBI).
NCT05426967 — Depressive Symptoms
Status: Not yet recruiting
http://inclinicaltrials.com/depressive-symptoms/NCT05426967/
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Agomelatine in the Prevention of Poststroke Depression
The incidence of depression in stroke patients with frontal lobe involvement was reported to be as high as 42%. Agomelatin, a type 1/2 melatonin receptor agonist and serotonin 2C receptor antagonist, is effective in treatment of depression, but whether it can prevent poststroke depression (PSD) remains unknown. The PRAISED trial is a multicenter, randomized, double-blind trial and is designed to evaluate the efficacy and safety of agomelatine in the prevention of PSD in stroke patients with frontal lobe involvement. The primary outcome is the rate of post-stroke depression for 180 days.
NCT05426304 — Depression
Status: Not yet recruiting
http://inclinicaltrials.com/depression/NCT05426304/
The Effects of Videogames on Depression Symptoms and Brain Dynamics
The purpose of the study is to evaluate the effects of a game-based digital-therapeutics (DTx) medical software device on the symptoms of depression in adults with confirmed major depressive disorder.
NCT05426265 — Major Depressive Disorder
Status: Active, not recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT05426265/
Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression
Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. In fact, there is an FDA-approved depression protocol to stimulate the dorsolateral prefrontal cortex (dlPFC). Its efficacy and safety have improved significantly with continued research and clinical experience. However, it is not known how to identify potential patients who would benefit most from treatment. The primary goal of this study is to determine if changes in specific electroencephalogram (EEG) parameters after treatment can predict whether patients are responders or non-responders to rTMS. The second objective is to analyze changes in the functional connectivity of specific brain regions in responders compared to non-responders. The hypothesis is that through rTMS treatment, investigators will be able to increase the activity in the frontal region that includes the dorsolateral prefrontal cortex (DLPFC). Scalp EEG signals will be processed in order to compare EEG brain connectivity and Frontal alpha asymmetry index (FAA) to determine if there are differences before and after the treatment. EEG FAA is usually calculated by subtracting the right-side EEG power estimates from the respective counterpart on the other side. According to literature, depressive patients seem to have comparatively higher left frontal alpha power. Cortical activity is related to a reduced EEG power, which is reflected in depressed subjects. On the other hand, higher alpha power could also be interpreted as inhibition. Investigators will try to delineate changes in resting EEG functional connectivity before and after high-frequency left prefrontal rTMS, by using biomarkers such as: time/frequency connectivity, Alpha asymmetry index, among others. TMS also allows cortical properties, such as excitability, inhibition, oscillatory activity and connectivity to be directly probed within a specific region of the cortex. Other studies suggest that alterations in gamma oscillations in the dorsolateral prefrontal cortex and neighboring frontal regions are also potential shared biomarkers in psychiatry, highlighting the potential of EEG signals to help identify suitable biomarkers. Given its relative low cost and ease of use, when compared to brain imaging tools such as magnetic resonance imaging (MRI) or positron emission tomography (PET), EEG could be added to the clinical study so that precise neurophysiological changes before and after treatments can be assessed.
NCT05424224 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05424224/
Efficacy of Acupressure in Depression as Non-invasive Nursing Intervention - a Randomized Single-blind Trial With Psychological and Physiological Criteria
A new nursing intervention with non-invasive acupressure protocol for activation of parasympathetic nervous system to reduce stress related depression symptoms.
NCT05423405 — Depressive Symptoms
Status: Not yet recruiting
http://inclinicaltrials.com/depressive-symptoms/NCT05423405/
Light and Ion Maintenance In Treatment for Depression (LIMIT-D): Feasibility Study
Antidepressants are widely used as first-line treatments for major depressive disorder (MDD). Clinical guidelines recommend 6-24 months of "maintenance" antidepressant treatment, after patients achieve symptom remission, to prevent relapse but many people stop antidepressants too soon relapse into another depressive episode. We will test non-medication treatments, negative ion therapy and light therapy, to see they can substitute for antidepressants to prevent relapse. This is a "feasibility" study to see if participants use study treatments properly, before doing a larger, definitive trial. In this 28-week study, 100 participants with recurrent MDD who are in remission with antidepressants will be treated with light therapy or negative ion therapy (with half of devices active and half inactive) while slowly discontinuing the antidepressant, and monitored for relapse.
NCT05423275 — Major Depressive Disorder, Recurrent, in Remission
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder-recurrent-in-remission/NCT05423275/
New Form of Brain Stimulation Targeting Dorsomedial Prefrontal Cortex in Treating Refractory Depression and the Predictive Biomarkers of Antidepressant Efficacy
Major depressive disorder (MDD) is a common and troublesome disorder, with high risk of physical and psychiatric comorbidity. At least one-third of patients could not achieve a response after several antidepressant trials, so-called treatment-refractory depression (TRD). The high-frequency repetitive transcranial magnetic stimulation (rTMS) or intermittent theta-burst stimulation (iTBS) at left-sided dorsolateral prefrontal cortex (DLPFC) have a response rate of 40-60%. Obviously, not all TRD patients achieve the remitted state after treatment with antidepressants or DLPFC-rTMS, which may result from the heterogeneity of MDD. More and more evidence, such as brain lesion studies, deep brain stimulation, open-labeled rTMS case series, and neuroimaging studies, suggests that dorsomedial prefrontal cortex (DMPFC) might play a more central role in the pathophysiology of major depression. The DMPFC demonstrated as a "dorsal nexus" phenomenon in depression, which means a unique brain region where cortical networks for affect regulation, default mode control and cognitive control coverage in depressed subjects but not in healthy persons. In addition, another meta-analysis of resting-state functional MRI (fMRI) demonstrated the abnormal functional connectivity from DMPFC. These abnormalities of networks were highly associated with several depressive symptoms such as anhedonia, emotional regulation, somatic markers, rumination, self-reflection, poor attention and poor decision-making. However, only a handful of studies investigated the brain stimulation targeting DMPFC and the further changes in brain functional connectivity. The clinical efficacy and the fMRI changes of prolonged intermittent theta-burst stimulation (piTBS) and 20Hz- rTMS targeting bilateral DMPFC were investigated, and the predictive value of baseline networks by fMRI for antidepressant responses was also assessed to find a reliable approach to gauge treatment response prospectively.
NCT05422417 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT05422417/
The Effect of Listening to Holy Quran Recital on Depression, Anxiety, and Stress Post CABG: A Randomized Control Trial
Coronary artery bypass graft (CABG) is one of the most common surgical treatments for coronary artery disease. CABG has many beneficial outcomes for patients. However, there are diverse factors that hinder these positive outcomes. Depression, anxiety, and stress (DAS) are considered as important factors that hinder these outcomes. Depression is very common post CABG. Despite that high levels of depression, more than half of patients undergoing CBAG are not screened or treated well for depression. Depression has negative outcomes for patients undergoing CABG. Similarly, patients undergoing CABG complain from high levels of anxiety and stress in the pre and even in the post-operative period.Anxiety and stress might be manifested as impaired functional status, chest pain, and shortness of breath.· Furthermore, increased anxiety and stress is correlated with poorer quality of life and worse long-term psychological outcomes.It has been shown that the speed of recovery from acute cardiac events depends more on psychological factors rather than physiological ones. Therefore, it is imperative to have an appropriate management for these negative emotions to improve the outcomes of this major operation. Treatment options for these emotions include pharmacological and non-pharmacological. Listening to the holy Quran recital is one of the non-pharmacological treatment methods that were integrated to improve Coronary Heart Diseases Patient's DAS symptoms. Previous studies showed that listening to the holy Quran recital was effective in reducing ADS symptoms among this population and other populations including hemodialysis, pregnant women, and smokers. However, this effect has not been checked for patients undergoing CABG. Therefore, the purpose of this randomized control trial (RCT) is to check the effect of Holy Quran recital on ADS among patients undergoing CABG surgery
NCT05419544 — Patient Depression, Anxiety, Stress and Pain
Status: Recruiting
http://inclinicaltrials.com/patient-depression-anxiety-stress-and-pain/NCT05419544/
Video-visit Behavior Therapy for Anxiety and Depression in Youth
This project focuses on adapting and pilot testing an efficacious brief behavioral therapy (STEP-UP) for youths with anxiety or depression to be delivered as a telehealth intervention by clinic staff in low-resource community health centers (CHCs).
NCT05417412 — Depression
Status: Completed
http://inclinicaltrials.com/depression/NCT05417412/