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Major Depressive Disorder - ClinicalTrials.gov

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Last Updated: 21 July 2022

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In Vivo Cortical Excitability Modulation in Major Depressive Disorder

Study objectives The aim of this research is to determine differences in cortical excitability modulation by a repeating Transcranial Magnetic Stimulation technique between patients with Major Depressive Disorder and healthy people. When compared to healthy individuals, patients with MDD have less cortical excitability. The study participants will complete a psychophysical task on a computer game in order to analyze certain cognitive functions and determine if there are differences in outcomes between patients with depression and healthy subjects. Patients with active/symptomatic MDD will be included in one cohort, and the second cohort will include patients with MDD in remission who are still in treatment. Participants in the study will not be compensated monetarily in two consecutive sessions with the same protocols, although they will be rewarded for travel to the Clinical Center, which may be helpful outside of their individual clinical follow-up.

Source link: https://clinicaltrials.gov/ct2/show/NCT05441969


PET Imaging of Cyclooxygenase in Participants With Major Depressive Disorder (MDD)

The study will explore whether cyclooxygenase 1 and cyclooxygenase-2 are detectable in the brain of people with significant depressive disorder. Group B - Calculation of the density of COX-1 using [11C]PS13 Secondary Endpoints, which is common to both groups: the association between peripheral markers of inflammation and COX binding; the association between clinical rating scales and COX binding; and the correlation between clinical rating scales and COX binding; Group B - Calculation of the number of inflammation and COX binding; and group B - determination of COX-1 using [11C]PS13 Secondary Endpoints; Group B -.

Source link: https://clinicaltrials.gov/ct2/show/NCT04582916


Near-infrared Transcranial Laser Therapy in Subjects With Major Depressive Disorder: A Study of Dosing With Laser

The main aim of the research: To determine and compare the effects of each of the four doses of Near-infrared Transcranial Laser Therapy on depression symptoms: an antidepressant effect in people with significant depressive disorder. This research will randomly assign 112 individuals into four equal groups: bilateral continuous wave y SHAM, bilateral pulsed wave This work will randomly assign 112 subjects to four equal groups: bicontinuous wave y SHAM, bipolar pulsed wave y SHAM Group assignments will be known by the device's operator. For six weeks, all subjects will receive three NIR-TLT treatments per week. Patients with significant depressive disorder according to DSM guidelines. Subjects will be monitored in the study for 8 weeks, according to a 10-week study duration. Assessment criteria: The most important efficacy measure is the decrease in depressive signs from each of the four doses of NIR-TLT.

Source link: https://clinicaltrials.gov/ct2/show/NCT05435820


A Randomized, Double-Blind, Support-of-Concept Phase 2 Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD)

Major depressive disorder has exploded into a health problem of epidemic proportions in the modern world. Major depression is expected to rank second in the United States after cardiac disease as a cause of international medical morbidity by the year 2020, according to the United States' one in every six people, and second after major depression. Depression is linked to higher disability than those other chronic illnesses and is a risk factor for mortality. Psilocybin may have behavioral implications relevant to depression management, according to previous research, and newest ones indicate that psilocybin may have antidepressant properties. This trial will enroll 100 participants aged 21 to 65 who meet MDD guidelines to better determine the effects of psilocybin on MDD signs and symptoms. Participants will be stratified by study site and randomly distributed with a 1-to-1 allocation under double-blind conditions in order to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. The primary aim of this study is to determine the potential safety of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo niacin, as the change between groups in depressive symptoms from baseline to Day 43 post-dose.

Source link: https://clinicaltrials.gov/ct2/show/NCT03866174


Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder

We will continue our recent findings of glutamatergic modulators' immediate effectiveness by investigating the safety and efficacy of repeated doses of ketamine in MDD patients during the repeat-dosing phase. Patients with a series of infusions will be included in any MDD patients regardless of antidepressant reaction to single infusions of ketamine, allowing for potential identification of patients who are able to obtain and/or maintain a response. The study population was based on 50 patients with treatment-resistant MDD between 18 and 65 years old, as well as 50 age-matched HVs. Study Design This report is a Phase I Clinical Trial with four phases. This research is a Phase I Clinical Trial with four phases. Both a placebo and MEG will be administered simultaneously with each infusion, with either resting-state fMRI with simultaneous EEG or resting state MEG recording, ensuring that every subject receives both a placebo and MEG. Following the final infusion in Phase II, MDD patients whose depression symptoms relapsed. Subjects will be randomly assigned to receive ketamine at 0. 5 or 0. 1 mg/kg twice a week for four weeks. Patients who completed Phase III and who are responders are included in Phase IV. Subjects will be given a single infusion of ketamine concurrently with serial peripheral blood testing. During the ketamine infusion process, some participants may also have serial CSF testing performed. Outcome Measures The primary outcome measure of Phase II is the pharmacodynamic fMRI and MEG responses to ketamine relative to placebo. Subjects will continue Phase IV for 4 weeks or until they relapse.

Source link: https://clinicaltrials.gov/ct2/show/NCT03065335


A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder

During each session continuous theta burst stimulation, which 1800 pulses are delivered in 2 second bursts, is administered first to the left dorsolateral prefrontal cortex in which 1800 pulses are delivered in a continuous fashion for 570 seconds. During each session continuous theta burst stimulation, which includes 1800 pulses in 2 seconds for 570 seconds to the left dorsolateral prefrontal cortex, is delivered in a continuous burst stimulation.

Source link: https://clinicaltrials.gov/ct2/show/NCT04502758


Near-infrared Radiation-transcranial Photobiomodulation for Major Depressive Disorder: From Cellular, Animal Studies to a Sham-controlled Double-blind Randomized Clinical Trial

Major depressive disorder is a leading cause of modern society's overall global burden of disease, and it is projected to rise to the first place by 2030. Dr. Paolo Cassano, MD, PhD, and his research at the Massachusetts General Hospital of Harvard University recently demonstrated that near-infrared radiation-photobiomodulation is a well-tolerated and cost-effective treatment modality for MDD, and that hypothesized NIR-tBBM can stimulate brain function, be anti-inflammatory, reduce oxidative stress, and promote neurogenesis. So far, clinical trials have been either open-labeled or only on a small scale, and the actual antidepressant mechanism of NIR-tPBM has yet to be fully understood. We'll culture and test the human neuron-like cell lines with continuous NIR-PBM of different dosimetry and length in the cellular research, and see the differences in cellular circadian rhythm, energy metabolism, and inflammation indicators as well as the underlying gene expression in the cellular research. The mice that have lived in a constant stress environment will be treated with different NIR-tPBMs of different durations in the animal study. The clinicians' report and recommendation for 8 weeks will run a prospective, double-blind, randomized, sham-controlled trial, recruiting full 80 MDD patients age 18 to 75, and applying adjunctive NIR t-PBM to the dorsolateral prefrontal cortex, bilaterally and simultaneously. In the 0, 2, 4, 8, 12 weeks and compared, the change in depressive symptoms and circadian habits will be recorded in the 0, 2, 4, 8, 12 weeks and compared.

Source link: https://clinicaltrials.gov/ct2/show/NCT04619121


Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders Compared to Standard Cognitive Behavioral Therapy: A Randomized Controlled Superiority Trial

Background: Although women are twice as likely to suffer from major depressive disorder than men, there are still over 100 million men affected by this disease worldwide. Men suffering from MDD typically receive mental health services about 30% less than women, leaving a substantial number of men with unanswered mental problems. Both men and women have twofold higher rates of alcohol use disorder and fourfold higher rates of completed suicide, respectively, while MDD is a common risk factor for both males and females. Although cognitive behavioral therapy is a beneficial therapy for MDD, conformation to traditional masculinity norms based on skepticism, self-reliance, and stringent emotional boundaries often discourages men from participating in psychotherapy. According to existing research, a need for diagnostic and treatment services that could persuade more men to engage in psychotherapy based on a male-tailored theme, focusing on male-specific topics and being introduced in male-typical settings. MDD patients with weekly therapy sessions for over 18 weeks will be offered to MSPP and CBT intervention groups. Expected results: The treatment groups are expected to be more efficient and cost-efficient at week 24 and a follow-up week 36, respectively. In addition, it is likely that the first hypogonadal men in the parallel groups will have greater symptoms due to TT as compared to the eugonadal men in the parallel groups, and that TT receiving men have an adjunct effect of added psychotherapy relative to waiting men.

Source link: https://clinicaltrials.gov/ct2/show/NCT05435222


Evaluating the Efficacy and the Acceptability of the Website "Ich Bin Alles" to Improve Depression Literacy in Parents of Adolescents With Acute or Remitted Major Depressive Disorder

In time, few young people with a significant depressive disorder receive medical assistance. Parents' knowledge and attitudes regarding depression and mental health in childhood and adolescence are critical to raising parents' emotional health and reducing potential prejudices and barriers towards depression and therapy. These features may lead to more parents seeking professional assistance and treatment for their children at an early stage in the course of a depressive disorder. The website contains general information for parents about depression in childhood and adolescence. In addition, the website has information about how to help their children if they are affected by depression and on effective prevention techniques, i. e. , programs for promoting mental stability in adolescents. Parents should encourage their children to request assistance with depression as early detection of depression is more likely and encourage parents to encourage their children to seek treatment for depression. Parents of healthy adolescents The new report will focus on target group 1: Parents of adolescents with a major depressive disorder Since the website caters to two different audiences, the investigators will review the site accordingly. The main aim of this report is to determine whether or not the website "ich bin alles!>" can help increase depression education among parents of adolescents with acute or repressed depressive disorder.

Source link: https://clinicaltrials.gov/ct2/show/NCT05335564

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions