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288 active trials for Major Depressive Disorder

ON/OFF Stimulation and Reward Motivation in Patients With Deep Brain Stimulators

We propose to study approach/avoidance behavior as measured by the Approach Avoidance task in 20 epilepsy patients undergoing implementation of depth electrodes for seizure monitoring in the Epilepsy Monitoring Unit at MGH. We will also study the effects of VC/VS electrical stimulation on approach-avoidance conflict in 20 adult patients who have undergone DBS implantation for severe MDD and/or OCD. There are 100-200 patients in the world with DBS electrodes in the VC/VS, and our research team cares for more than any other institution. Both participant groups will be assessed with respect to reward-aversion decision conflict using the task. The task will be performed with concurrent EEG recordings in DBS patients, and with continuous recording through our invasive neurophysiology rig in EMU subjects.

Start: January 2021

Sumor as Adjuvant Therapy in Treatment-resistant Major Depression

Sumor is a food supplement that combines the main coenzymes of the S-Adenosyl methionine (SAMe) cycle, namely vitamins B6, B12 and folate, with SAMe and betaine. Sumor also contains vitamin C, a molecule that has shown promise in the treatment of depression in experimental models, and selenium, an antioxidant agent whose blood deficiency has been associated with depressive symptoms in some preliminary studies. There are no studies in the literature on the efficacy of this combination in the adjuvant therapy of depression. The purpose of this study is to compare the effects of Sumor in co-therapy with an SSRI antidepressant versus co-therapy with placebo in patients with treatment-resistant Major Depressive Disorder.

Start: June 2021

Testing the Neuroscience of Guided Learning in Depression

Major depression is a prevalent and impairing illness. To better understand the basic science and treatment of depression, the investigators study the behavioral and brain processes associated with learning in depression and how potential disruptions in learning may be repaired. Understanding different methods that change learning may lead to novel treatments that contribute to recovery in people with depression.

Start: May 2016

The Efficacy of Automated Feedback After Internet-based Depression Screening

The DISCOVER randomized controlled trial is designed to evaluate the effect of automated feedback after internet-based depression screening in individuals with undetected depression. A total of 1076 individuals reporting elevated levels of depression (PHQ-9 score ? 10 points) will be randomized into three groups to either receive a) no feedback (control group), b) standardised or c) tailored feedback on their depression screening results.The primary hypothesis is that feedback reduces depression severity six months after screening compared to no feedback. The secondary hypothesis is that tailored feedback is more efficacious as compared to standard feedback.

Start: January 2021

Mechanism of Action of Transcranial Magnetic Stimulation

This is an observational neuroimaging study assessing the effects of TMS on the brains of patients with unipolar depression.

Start: November 2011

Comparing Efficacy of Optimal Treatment and Conventional Treatment for Major Depressive Disorder in Viet Nam

Comparison of efficacy treatment (respond, remission) between the optimized treatment group (dose adjustment or early change other drug based on the change of total score HAM-D 17) and the routine treatment group (start with the lowest effective dose and adjust dose slowly) for depressed patients in Viet Nam

Start: March 2021

Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi

In recent years, Cognitive Behavioral Therapy has been integrated with mindfulness meditation (CBT-M) following evidence for increased efficacy when modalities are combined. We will assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults with major depressive disorder (MDD). This non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.

Start: April 2021

A Longitudinal Study of Inflammatory Pathways in Depression

Suicide accounts for at least 1 million deaths globally each year. This is likely a significant underestimate, because suicide is under-reported in many countries. In the US, over 42,000 people die from suicide annually. Despite increased focus on identification and treatment, the rate of suicide has increased steadily over the past 15 years. Our project aims both to improve our understanding of factors that increase the risk for suicide by comparing blood biomarkers associated with inflammation in patients with depression without suicidal behavior and patients with depression and suicidal behavior. The 160 individuals in this study will be followed with psychiatric assessments and blood samples at repeated time points over one year.

Start: October 2019

Trial to Evaluate the Effectiveness of Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder

This study compares the effectiveness and safety of 2 digital therapeutics in adult subjects diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.

Start: February 2021

Mechanistic Evaluation of Response in TRD (MERIT)

To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD). This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.

Start: August 2020

Antidepressant Response in Older Adults With Comorbid PTSD and MDD

In the Investigator's ongoing studies of Posttraumatic Stress Disorder (PTSD) in older adults, it has been found that older adults with PTSD frequently meet the criteria for comorbid Major Depressive Disorder (MDD). Moreover, relative to trauma-exposed healthy controls (TEHCs), elders with PTSD manifest executive function deficits, fatigability, and mobility and physical function deficits that are consistent with what the investigator has observed in depressed older adults. Yet, the investigator has found that very few older adults with combined PTSD/MDD have received appropriate antidepressant treatment for their condition. These findings give rise to the questions of (1) how effective is antidepressant treatment for depressive symptoms in the context of PTSD/MDD and (2) are cognitive and physical function deficits in PTSD/MDD patients reversible with effective antidepressant treatment?

Start: March 2021

Gut Feeling: Understanding the Mechanisms Underlying the Antidepressant Properties of Probiotics

Previous research has suggested that probiotics can improve depressive symptoms in patients with Major Depressive Disorder (MDD), particularly when used in addition to antidepressants. The aim of this exploratory pilot study is to improve the investigator's understanding of the mechanisms underlying these effects. This study will assess the effects of an 8-week double-blind placebo-controlled probiotic intervention on the gut microbiome, inflammatory marker levels, brain activity and neurotransmitter levels in patients with MDD and their relationship to changes in mood. This study will also recruit a group of demographically-matched healthy controls for gut microbiome comparison with the MDD group (non-interventional).

Start: July 2019

A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

This is a Phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult participants with MDD.

Start: February 2019

SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients

SPL026 (N,N-dimethyltryptamine [DMT] fumarate) is a psychedelic tryptamine being developed as a therapy for patients with major depressive disorder (MDD).

Start: February 2021

Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach

This project aims to evaluate whether a dose-response relationship exists between dose of polyunsaturated fatty acids (PUFA), delivered as eicosapentaenoic acid (EPA), and change in markers of inflammation, and whether these effects differ from placebo. A key secondary aim is to evaluate the antidepressant effectiveness of EPA in overweight adult outpatients with current major depressive disorder (MDD). To address these aims, the project will use a four-arm, randomized, parallel-group, placebo-controlled design comparing placebo versus three doses of EPA (1 gm/day, 2 gm/day, or 4 gm/day) administered over 12 weeks. The study is to be conducted at two sites: Emory University School of Medicine, and Massachusetts General Hospital. Eligible participants will be between the ages of 18-80 who have current MDD, are overweight, and who demonstrate peripheral inflammation, defined as an high sensitivity C-reactive protein (hs-CRP) level ? 3 mg/L. The primary outcome will be change in plasma interleukin-6 (IL-6) levels and/or mitogen-stimulated peripheral blood mononuclear cells (PBMC) Tumor Necrosis Factor-alpha (TNF-?) expression levels in EPA- versus placebo-treated participants. The results of this investigation are intended to be used to design and power a larger definitive test of the efficacy and biological effects of EPA in patients with major depressive disorder.

Start: December 2015

Novel Neural Circuit Biomarkers of Major Depression Response to CCBT

The purpose of the study is to learn more about computer-assisted cognitive behavioral therapy or "CCBT" and to examine connections in the brains of patients with depression. CCBT is approved by the FDA as a form of treatment for depression. It is done partly on the computer and partly with a therapist. This study will enroll participants with depression and participants without depression. The investigators will recruit a total of 100 participants: 80 with Major Depressive Disorder (MDD) and 50 matched comparison participants. Healthy control subjects will participate for approximately 8 weeks. All MDD participants will receive CCBT. Half of the MDD participants will all receive computer-augmented skills training with the Good Days Ahead (GDA) protocol immediately (Early CCBT). Early CCBT subjects will participate for approximately 8 weeks. The other half of the MDD participants initially will be randomized to a waitlist of up to 4 weeks and subsequently will receive CCBT treatment (Late CCBT). Late CCBT subjects will participate for approximately 12 weeks. All participants are asked to complete a screening, which includes a series of clinical interviews and self-report questionnaires about the individual's thoughts, moods, and behaviors. All participants are asked to wear an actigraph, which is a watch-like device that measures activity levels. Additionally, participants are asked to completed short questions and have their activity levels monitored through phone app(s). All participants (Healthy Control and MDD participants) will receive functional magnetic resonance imaging (fMRI) scanning at baseline. Early CCBT participants will receive fMRI scanning after 8 weeks of CCBT, and Late CCBT participants will receive fMRI scanning at the conclusion of the waitlist and after the 8-week course of CCBT. Brain activity will be compared between MDD and controls at baseline and between Early CCBT vs Late CCBT. The 2nd and 3rd brain scans of Late CCBT participants at the end of the waitlist and 8-week course of CCBT, respectively, will allow within-subject comparison of CCBT vs Waitlist treatment effects. This clinical trial has two IRB protocol numbers: 826910 and 832295. The data collected through both protocol numbers will be analyzed together to accomplish the target of 100 subjects for this clinical trial.

Start: June 2017

A Phase 2 Trial of OPC-64005 for Major Depressive Disorder

The objective of the trial is to compare the efficacy of OPC-64005 at 20 mg vs placebo and to assess the safety and pharmacokinetics of OPC-64005 at 10 and 20 mg in patients with major depressive disorder (MDD).The primary endpoint is the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 of the double-blind treatment period in the OPC-64005 20-mg group compared with the placebo group

Start: March 2020

Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery

This study evaluates whether ketamine, given as part of an anesthetic, improves depression symptoms in depressed patients undergoing total joint replacement surgery. Half of participants will receive a ketamine infusion during surgery, while the other half will receive a placebo (normal saline) during surgery.

Start: August 2019

The BIomarker Guided Study for Depression

The diagnosis of major depression relies on patient reports, and two patients with the same diagnosis might share only one symptom. Thus, a single mechanism is unlikely to underlie a broad descriptive diagnosis such as major depression. Our approach is anchored by a neural circuit taxonomy that proposes distinct biotypes of depression derived from functional magnetic resonance imaging (fMRI) (Williams et al., 2016). In this study, we aim to target a putative type of major depression that arises from dysfunction in cognitive control neural circuitry with a drug called guanfacine.

Start: October 2021

Trial of MR-guided Focused Ultrasound for Treatment of Refractory Major Depression

The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with treatment-refractory Major Depression. This study is designed as a prospective, single arm, nonrandomized study. Assessments will be made before and after MRgFUS for adverse events related to treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain chosen for ablation will be the anterior limb of the internal capsule (i.e 'capsulotomy').

Start: January 2018