View clinical trials related to Major Depressive Disorder.
Filter by:This is a 2-part, double-blind, randomized, placebo-controlled, first-in-human trial evaluating a single ascending dose (4-way crossover, Part A) and multiple ascending doses (Part B) of CVL-354.
This is a prospective, single-arm, open-label study to evaluate the safety and efficacy of Xiongdan Wan monotherapy in patients with Major Depressive Disorder(MDD), conducted in Shang Hai Mental Health Center. Following a screening period, subjects who meet the entry criteria will be treated with 450mg Xiongdan Wan pills three times daily for 8 weeks.
Attaining goals or rewards commonly entails response costs. In light of cost and benefits, how do participants decide what effort should be put in to give it a shot? Figuratively, you may "go with your gut", but the literal contribution of the gut-brain axis in allocating effort is poorly understood to date. Here, the investigators propose to investigate non-invasive transcutaneous vagal nerve stimulation (tVNS) as a potential modulator of energy metabolism and response vigor. Since the neural mechanisms causing the diverse cognitive and behavioral effects of the stimulation remain largely elusive, the investigators will use computational modeling of instrumental behavior and determine the primary metabolic effects of the stimulation. The investigators hypothesize that tVNS will lead to activation of afferent targets in the brain. In turn, the elicited brain activation is expected to mediate the cognitive effects of the stimulation. This may affect both sides of the utility equation because anti-depressive effects may correspond to boosting the benefit of effort whereas anti-nociceptive effects may reduce perceived costs of effort. Collectively, dissecting the cognitive effects of non-invasive tVNS in healthy individuals may facilitate the more widespread use as a treatment in mental disorders that are characterized by metabolic alterations such as depression.
The purpose of this study is to collect biologically-based data for defining predictors and correlates of the effects of ALTO-300.
The goal of this study is to collect biologically based data for defining predictors and correlates of the effects of ALTO-100.
Background: Depression is a highly recurrent disorder, which often requires lifelong treatment. Psychotherapy has an important role in the treatment of depression, both in the treatment of the acute phase and in prevention of relapses. Mindfulness-based therapies have become popular in the last decade. Mindfulness-based Cognitive Therapy (MBCT) is an established treatment for relapse prevention in Major Depressive Disorder (MDD) and there is preliminary evidence of its efficacy in treating acute symptoms. Several studies have highlighted the benefits of MBCT in reducing the severity of depressive symptoms in patients diagnosed with a current Major Depressive Episode, as indicated by some meta-analyses showing that MBCT is more effective than treatment as usual in decreasing depressive symptoms and equivalent to active treatments. However, the results at follow-up were less conclusive, due to the limited number of studies and moderate-to-large heterogeneity within the subgroups. A number of studies have examined the effects of MBCT on a larger spectrum of factors that can affect the severity of depression. In patients with MDD, MBCT was more effective than treatment as usual in decreasing rumination, worry, negative affect and dysfunctional attitudes, increasing mindfulness skills and positive affect and improving sleep and quality of life. However, data comparing the specific effect of MBCT with other active treatments (for example Cognitive Behavioural Therapy, CBT) are lacking. Most trials exploring the efficacy of MBCT have been conducted with group MBCT, but there is less evidence about the use of individual MBCT (I-MBCT). Individual MBCT may have some advantages, compared with group therapy, such as better attendance and higher efficacy in major depression, when compared with group therapy. Furthermore, the individual format can often be better tailored to a specific patient, with a slower progression and a longer number of sessions, if needed. Objective: The primary objective of this pilot trial was to test the feasibility of a larger randomized trial examining the changes in depressive and anxiety symptoms, rumination, mindfulness, emotion regulation, behavioral activation and negative automatic thoughts during I-MBCT and cognitive behavioural therapy (CBT). Further objectives were: (a) replicating studies evaluating the efficacy of I-MBCT to improve depression, in particularly in patients diagnosed with a major depressive disorder; (b) assessing the persistence of benefits of I-MBCT after the end of treatment; (c) comparing the effects of I-MBCT with CBT, not only on depressive symptoms, but also on factors which are specifically targeted by MBCT, such as rumination and mindfulness; explore possible predictors of outcome of MBCT. Hypotheses: We make the following hypotheses: a) a larger trial comparing I-MBCT with CBT examining the changes of depressive and anxiety symptoms, rumination, mindfulness, emotion regulation, behavioral activation and negative automatic thoughts is feasible, with recruitment rates and drop-off rates consistent with those usually observed among participants with current major depression; b) the levels of depressive and anxiety symptoms, rumination, emotion dysregulation, and negative automatic thoughts will decrease during I-MBCT, while the levels of mindfulness and behavioral activation will increase, with effect sizes similar to those observed in CBT; c) the changes in depressive and anxiety symptoms, rumination, emotion dysregulation, negative automatic thoughts, mindfulness and behavioral activation will be maintained at follow-up; d) the changes in mindfulness and rumination dimensions are expected to be larger during MBCT than CBT; these analyses will be exploratory, given the state of knowledge; d) we will explore the role of predictors of clinical variables, such as earlier age at onset of the mood disorder; longer and more severe current episode; presence of current comorbidity with anxiety disorders, initial levels of anxiety, behavioral activation, emotion dysregulation and of the history of severe childhood maltreatment in predicting the outcome to MBCT and CBT.
Investigating whether delta-beta cross-frequency transcranial alternating current stimulation can increase goal-directed behavior in participants with major depressive disorder and elevated symptoms of anhedonia.
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as a monotherapy for Major Depressive Disorder.
participants will be receiving OMT 1x/week for 8 weeks. Each appointment with be a duration of 30 minutes. Patients will be required to fill out PHQ-9 and SSS-8 questionnaires before beginning the study and following the conclusion of the study.
This single-arm feasibility trial administered up to 8 weekly (early phase) or 4 bi-weekly (later phase) whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions to adults aged 18 years or older with major depressive disorder (MDD).