View clinical trials related to Depressive Disorder, Major.
Filter by:The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are: - What is the safety of single ascending doses of the FluoroEthylNorMemantine (FENM)? - What is the PK profile of single ascending doses of the FENM in human? - What is the preliminary exploratory time course of Brain Disease Neurotrophic Factor (BDNF) plasmatic levels of single ascending doses of the FENM? Participants will receive one single oral dose of FENM.
Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin.
This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting. In order to investigate the effects of length of time on SSRI therapy, 30 participants with varying lengths of time on SSRI therapy will be enrolled, stratified into four groups: - Group 1: ≤ 1 year - Group 2: 1 to ≤ 5 years - Group 3: 5 to ≤ 10 years - Group 4: > 10 years
This is an open-label, parallel-group, randomized clinical trial of up to 6 months treatment of adjunctive intranasal (IN) esketamine (ESK) vs. adjunctive aripiprazole (ARI) in Veterans with unipolar Treatment Resistant Depression (TRD). This study will assess the efficacy, safety, and acceptability of adjunctive IN ESK in comparison to ARI, one of the best studied and most widely used adjunctive therapies for TRD. The primary hypothesis is that participants receiving adjunctive IN ESK will be significantly more likely to achieve remission after six weeks of treatment as compared to those who receive adjunctive ARI. Depressive symptoms will be assessed by central raters (CR), blinded to treatment assignment, using the clinician rated version of the Quick Inventory of Depressive Symptomatology (QIDS-C16), a well-validated tool that is commonly used and is easily translated across other depression inventory scales. The study is powered to detect an absolute difference in remission rates of 10%, or larger, at 6 weeks. Additional outcomes of interest include symptom reduction across 6 months of randomized therapy, side effects and other tolerability indices, attrition rates and measures of quality of life and cost-effectiveness.
The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.
The purpose of this study is to determine if any improvements in depressive symptoms are maintained in the medium and longer-term (up to 3 months)
This study aims to examine the effect of low-dose buprenorphine as an add-on to treatment-as-usual for suicidal ideation in individuals with major depression, and investigate the functional brain activity related to its potential anti-suicidal effect.
This open-label fMRI study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with treatment-resistant major depressive disorder.
The purpose of this study is to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity of depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via the use of questionnaires.
Utilization of therapist Assisted internet-delivered cognitive behavioural therapy (TAiCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT) and the Ontario Structured Psychotherapy Program (SPP), is a potential solution for addressing the treatment gap in mental health. Investigators propose to investigate the effectiveness of Beacon TAiCBT for Depression to demonstrate the potential value of TAiCBT in a stepped care model. Investigators propose to conduct a 12-week pragmatic randomized controlled trial with a 1:1 (iCBT intervention: waiting-list) allocation, for participants referred to the Anxiety and Mood, Prompt Anxiety and Mood, and Trauma Programs at Ontario Shores Centre for Mental Health Sciences and on a waiting-list to receive clinical service. The primary outcome measures will be the Improving Access to Psychological Therapies (IAPT) definitions of Recovery, Reliable Improvement, and Reliable Recovery which are derived using the PHQ-9 and GAD-7 . The PHQ-9 (Depression), GAD-7 (anxiety) and WSAS (functional impairment) will be used as secondary outcome measures for all participants. Over the course of the study, 200 participants will be randomized (iCBT, 100; waiting-list, 100). Statistical analyses will include intention-to-treat analyses to test the interaction effects for the primary outcome measures at discharge/12-weeks and 3, and 12 months post-treatment. It is predicted that participants in the treatment condition will show significantly reduced symptoms of depression related to the waitlist control. It is predicted that this will be maintained through follow up.