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288 active trials for Major Depressive Disorder

Vagal Nerve Stimulation for Treatment Resistant Major Depression

The purpose of this study is to 1) explore whether vagal nerve stimulation (nVNS) using a hand- held non-invasive device (gammaCore™) works to treat depression and 2) to confirm gammaCore™'s safety profile.

Start: September 2021

Vortioxetine in Patients With Depression and Early Dementia

This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia

Start: February 2020

Mild-Intensity Whole Body Hyperthermia (WBH) for Major Depressive Disorder

Overall, the objective of this pilot study is to utilize the IL-6 receptor antagonist tocilizumab to prospectively evaluate the role of IL-6 in the antidepressant and immunological effects of whole body hyperthermia (WBH). The study seeks to replicate findings thus far that WBH has an antidepressant effect by administering the intervention at a site not involved in studies to date. Moreover, the current proposal may help the investigators better understand the role of IL-6 in the pathogenesis and treatment of depression which might point to novel immune-based interventions for Major Depressive Disorder (MDD). Finally, the current proposal holds promise for better understanding of a novel treatment for MDD, which is among the leading causes of health-related disability in the world.

Start: September 2021

Antidepressant Effects of TS-161 in Treatment-Resistant Depression

Background: Major depressive disorder (MDD) is a common, chronic mental illness. It can take weeks to months for antidepressants to work. Researchers want to test a new drug that might act more rapidly. Objective: To see if TS-161 will improve symptoms of depression in people with MDD. Eligibility: Adults ages 18-65 with MDD without psychotic features. Design: Participants will be screened under a separate protocol. They will have blood tests. They will complete surveys about their symptoms. Participants will have an inpatient visit at NIH. Participation may last 12-16 weeks. During the first phase of the study, participants will be tapered off their psychiatric medicines. For 2 weeks they will have a drug-free period. During Phase II participants will take TS-161 or placebo. They will take TS-161 for 3 weeks and placebo for 3 weeks. In between the 3-week time period, they will have 2-3 weeks where they will be drug free. Participants will also have the following tests during this time: Interviews Physical exams Psychological tests and surveys about their symptoms Blood draws and urine samples They may complete tests of mood and thinking MRI (Magnetic resonance imaging): Participants will lie in a machine that takes pictures of their brain. Functional MRIs: They will perform tasks displayed on a computer screen inside the MRI scanner MEG (magnetoencephalography): Participants will lie down and do tasks of memory, attention, and thinking. A cone lowered on their head will record brain activity. Electrocardiograms to record the heart s electrical activity. Electrodes will be placed on the skin....

Start: June 2021

Study in Major Depressive Disorder With BTRX-335140 vs Placebo

A proof of concept (POC) study evaluating the impact of BTRX-335140 relative to placebo on symptoms of major depressive disorder (MDD) in adult subjects with MDD and symptoms of anhedonia and anxiety following 8 weeks of double-blind treatment as assessed by the HAMD-17 Scale.

Start: December 2019

ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

This study aims to determine whether treatment of CMV positive (CMV+) individuals with major depressive disorder (MDD) with valganciclovir (VGCV) alters neural circuitry, reduces inflammation, and improves depressive behavior and symptoms to a greater extent than placebo. In this double-blind, randomized placebo-controlled, parallel group trial, 24 individuals with a Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) scale score ? 14 will be enrolled to participate in an 8-week treatment study. Participants will be randomized with a 1-1 ratio to receive 900 milligrams (mg) VGCV or placebo to be taken orally once per day. Participants will complete a 2-hour pre-screen, a baseline blood-draw, clinical evaluation, and MRI scan (visit 2), a clinical evaluation, blood draw, and MRI scan at week 4 (visit 6), and a clinical evaluation, blood draw, and MRI scan at week 8 (visit 10). Weekly telephonic visits to assess depressive symptoms and side effects will held between the in-person assessments.

Start: July 2021

A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

HYPOTHESIS: Pregnenolone administration will be associated with greater reduction in depressive symptom severity than placebo in women with current mMDD. STUDY AIMS: Primary Aim: Determine if pregnenolone is associated with greater reduction in depressive symptom severity than placebo in women with mMDD, as measured by MADRS. Secondary Aims: Determine if pregnenolone is associated with greater reduction in anxiety symptom severity than placebo in women with mMDD. Determine if pregnenolone is associated with greater improvement in cognition than placebo in women with mMDD. Determine if pregnenolone is associated with greater improvement in quality of life than placebo in women with mMDD. Determine if pregnenolone is associated with greater improvement in vasomotor symptoms of menopause than placebo. Mechanistic Aims: Determine whether changes in neurosteroid levels with pregnenolone mediate clinical response. Determine if baseline neurosteroid levels predict pregnenolone response. Determine whether depressive symptoms, anxiety, sleep or vasomotor symptoms improve first. A crossed-lagged panel model will explore serial correlations between changes in outcome measures.

Start: September 2018

A Study of MD-120 in Patients With Depression

The purpose of this study is to verify the efficacy and evaluate the safety of 8-week once-daily oral administration of MD-120 in Japanese patients with depression.

Start: May 2020

The Effect of Celecoxib on Neuroinflammation in MDD

Major depressive disorder (MDD) affects an estimated 350 million people worldwide and is a leading contributor to global disease burden. Commonly used monoamine reuptake-inhibiting treatments for depression are suboptimal, resulting in only 30% of patients achieving remission. This may be because monoamine dysfunction is not the primary pathophysiology in all MDD patients. One avenue for the development of novel MDD treatments is through anti-inflammatory drugs; MDD is linked to a pro-inflammatory phenotype characterized by microglial activation, leading to the release of pro-inflammatory cytokines and upregulation of cellular markers including cyclooxygenase-2 (COX-2) and translocator protein (TSPO; a protein located on the outer membrane of microglia). Relevant to this proposal, TSPO can serve as an in vivo marker of neuroinflammation using the newly developed positron emission tomography (PET) tracer for TSPO, [18F]FEPPA. In support of this, a recent [18F]FEPPA PET study found that MDD patients in a current major depressive episode (MDE) had significantly higher TSPO binding in the prefrontal cortex (PFC), anterior cingulate cortex (ACC) and insula, relative to healthy controls. The prefrontal cortex and ACC are both implicated in mood regulation whereas the insula is involved in interoceptive signaling, which is known to be abnormal in MDD. Celecoxib, a selective COX-2 nonsteroidal anti-inflammatory drug (NSAID), is a promising new treatment for neuroinflammation in MDD. Clinical studies have observed that, in a subset of depressed patients, celecoxib treatment reduced depression severity as assessed by the Hamilton Depression Rating Scale (HDRS). While these findings demonstrate that celecoxib reduces symptom severity, PET imaging technology is critical for understanding how celecoxib affects the underlying pathophysiology of depression. Here, the team will investigate neuroinflammation as an underlying pathology in depression and test whether neuroinflammation is reduced by celecoxib in MDD patients. Specifically, in the proposed pilot study, MDD patients in a current MDE will receive [18F]FEPPA PET scans prior to and following 8 weeks of treatment with 800mg/day of celecoxib, with HDRS scores obtained at each time point. The investigators hypothesize that following celecoxib treatment, patients will show a significant reduction in neuroinflammation in the PFC, ACC and insula, which will correlate positively with the reduction in depressive symptoms, as measured by the HDRS. The proposed study will use novel imaging technology, [18F]FEPPA PET, to measure the effects of celecoxib on neuroinflammation in MDD patients. Our results will help to 1) identify neuroinflammation as an underlying pathology in MDD and 2) test whether reduction of inflammation is the mechanism of action of celecoxib. As such, the results of this study will aid in the development of targeted clinical treatments to improve remission rates in MDD patients.

Start: August 2018

Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder

Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety

Start: November 2021

XEN1101 for Major Depressive Disorder

This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a novel treatment target for mood disorders through the administration of the KCNQ-selective channel opener XEN1101 (Xenon Pharmaceuticals).

Start: June 2021

Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression

Previous research has shown that modulation of a brain region in rodents, the ventral tegmental area (VTA), improves depressive symptoms. Human research has also shown that VTA self-modulation using 'biofeedback' is feasible and successful in healthy volunteers. This biofeedback procedure is a type of cognitive training that includes real-time feedback about brain signal levels from the VTA. Our question is whether VTA self-modulation with biofeedback can influence depression symptoms.

Start: October 2019

Clonidine to Prevent Delirium After Electroconvulsive Therapy.

Electroconvulsive therapy (ECT) is a highly effective treatment for some psychiatric disorders like major depressive or bipolar disorder, but may lead to agitation and delirium after the procedure in up to 65% of patients. This can have negative side effects and be dangerous for patient and attending staff. Clonidine, a central-acting alpha2-receptor agonist, is an approved antihypertensive medication with known sedative side effects. Clonidine's newer but more expensive successor, dexmedetomidine, has recently shown its potential to reduce this kind of delirium. The investigators therefore hypothesise that pre-treatment with 2 mcg/kg clonidine prior to electroconvulsive therapy will significantly reduce the incidence of postictal delirium. This potentially makes a highly efficient treatment for patients with otherwise refractory psychiatric illness safer and more accessible.

Start: April 2021

Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone

Start: November 2018

Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder

This study evaluates the addition of light therapy with LUMINETTE device to usual treatment (antidepressant drug and psychotherapy) in the treatment of Major Depressive Disorder (MDD). Half of the participants will receive active light therapy with LUMINETTE device while the other half will receive placebo light therapy with LUMINETTE placebo device.

Start: January 2019

Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.

Start: September 2018

Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics

This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive disorder (MDD) and borderline personality disorder (BPD).

Start: June 2021

Allogeneic HUman Mesenchymal Stem Cell InfusioN Versus Placebo in Subjects With Alcohol Use Disorder and Major DepreSsion.

The purpose of this study is to look at the safety of a study treatment with stem cells in Alcohol Use Disorder And Major Depression (AUD-MD) subjects.

Start: March 2018

Deep Brain Stimulation (DBS) for Depression Using Directional Current Steering and Individualized Network Targeting

The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims: Demonstrate device capability to selectively and predictably engage distinct brain networks Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms

Start: August 2019

Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression

This study is being conducted to understand the use of a mobile app (titled Pathway) to help patients track depression symptoms, medications, side effects, and goals in addition to the usual care with their doctor. Investigators will compare the effect of the app over 6 months and examine whether the app can increase engagement between patients and their doctor and help in the management of illnesses as patients start a new treatment for depression. The investigators hope that using an app to facilitate management of depression symptoms, medication use, and side effects will help patients and their providers understand their response to medications and lead to better response and improvements in depression.

Start: February 2021