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Major Depressive Disorder clinical trials

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NCT ID: NCT05450432 Recruiting - Clinical trials for Major Depressive Disorder

Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression

Start date: October 13, 2022
Phase: Phase 4
Study type: Interventional

The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.

NCT ID: NCT05441969 Recruiting - Clinical trials for Major Depressive Disorder

In Vivo Cortical Excitability Modulation in Major Depressive Disorder

PDM-TMS
Start date: May 19, 2020
Phase:
Study type: Observational

The pathophysiology of Major Depression Disorder (MDD) is unclear, with several theories for its neurobiological mechanisms. One possible explanation is the presence of altered neuroplasticity, which can be studied by Transcranial Magnetic Stimulation (TMS). Using TMS to study these mechanisms is performed by applying electromagnetic stimuli to the motor cortex, to obtain measures of temporary cortical excitability modulation. It is known that depressed patients with higher cortical modulation are more responsive to a TMS treatment course. However, it is unknown if there are differences in cortical modulation between depressed patients and healthy subjects. Our goal is to answer this question and contribute towards clarification of the neuroplasticity mechanisms underlying MDD. Accordingly, the investigators will access cortical excitability modulation measures in both depressed patients and healthy volunteers and compare their results. The investigators will also re-assess these measures after 6 weeks of antidepressant treatment. Finally, the investigators will study the association between cortical excitability measures and cognitive processes using an innovative cognitive task.

NCT ID: NCT05437705 Recruiting - Anxiety Clinical Trials

Decoding and Modulating Affective Brain States

Start date: April 21, 2023
Phase: N/A
Study type: Interventional

Generating personalized brain signatures of negative emotion along with personalized brain stimulation protocols to disrupt these patterns. We plan to use fMRI and muscle activity data to determine negative affect maps for each participant. We will then try a variety of patterned repetitive transcranial magnetic stimulation sequences while recording fMRI which will be the basis of two sessions of 3-day individualized brain stimulation designed to reduce negative affect.

NCT ID: NCT05437588 Recruiting - Depression Clinical Trials

Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.

NCT ID: NCT05435820 Recruiting - Clinical trials for Major Depressive Disorder

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

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The Near-infrared transcranial laser therapy (NIR-TLT) is a non-ionizing electromagnetic wave. The NIR-TLT is invisible, penetrates the skin and skull into brain tissue and is non-invasive. The benefits of NIR-TLT are wavelength specific. A mitochondrial enzyme, the Cytochrome c oxidase, is the primary chromophore for the NIR-TLT with a wavelength of around 830 nm. When this enzyme is activated, it leads to increased adenosine triphosphate (ATP) production and this event is related to the promotion of cellular plasticity and cytoprotection. These are critical cellular processes for recovery of the depressive patients. Therefore, this study will contribute to answer the question of whether NIR-TLT has an antidepressant effect and whether it is acceptable in minority population.

NCT ID: NCT05435222 Recruiting - Clinical trials for Major Depressive Disorder

Evaluation of a Male-specific Psychotherapeutic Program for Major Depressive Disorders

MSPP-MDD
Start date: March 15, 2023
Phase: N/A
Study type: Interventional

This project aims to evaluate a male-specific psychotherapeutic program (MSPP) for MDD based on cognitive behavioral therapy (CBT). The primary goal is to test the superiority of the MSPP. This will be conducted in two groups of depressed men, namely eudonadal depressed men and hypogonadal depressed men receiving testosterone treatment (TT). In a randomized study design, the MSPP will be compared to a standard CBT and a waitlist control group, resulting in a total of six study groups. Both standardized psychotherapy programs will encompass 18 sessions delivered in a weekly manner, starting at study week 6 and continuing until study week 24. Aligned with the TT-related medical visits of the hypogonadal men, all participants will be followed up with clinical assessments and biosampling at weeks 0, 6, 15, 24, 36. In addition, a separate healthy control group will be examined, which will undergo only baseline assessments.

NCT ID: NCT05434156 Recruiting - Depression Clinical Trials

ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression

Start date: October 27, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A study to assess the safety and tolerability of a drug called ELE-101 and see how the body absorbs and removes the drug and how it affects the body in healthy adult participants (Part 1) and in patients with depression (Part 2).

NCT ID: NCT05422417 Recruiting - Clinical trials for Major Depressive Disorder

Dorsomedial Prefrontal Neuromodulation in Treatment-resistant Depression

Start date: June 7, 2022
Phase: N/A
Study type: Interventional

Major depressive disorder (MDD) is a common and troublesome disorder, with high risk of physical and psychiatric comorbidity. At least one-third of patients could not achieve a response after several antidepressant trials, so-called treatment-refractory depression (TRD). The high-frequency repetitive transcranial magnetic stimulation (rTMS) or intermittent theta-burst stimulation (iTBS) at left-sided dorsolateral prefrontal cortex (DLPFC) have a response rate of 40-60%. Obviously, not all TRD patients achieve the remitted state after treatment with antidepressants or DLPFC-rTMS, which may result from the heterogeneity of MDD. More and more evidence, such as brain lesion studies, deep brain stimulation, open-labeled rTMS case series, and neuroimaging studies, suggests that dorsomedial prefrontal cortex (DMPFC) might play a more central role in the pathophysiology of major depression. The DMPFC demonstrated as a "dorsal nexus" phenomenon in depression, which means a unique brain region where cortical networks for affect regulation, default mode control and cognitive control coverage in depressed subjects but not in healthy persons. In addition, another meta-analysis of resting-state functional MRI (fMRI) demonstrated the abnormal functional connectivity from DMPFC. These abnormalities of networks were highly associated with several depressive symptoms such as anhedonia, emotional regulation, somatic markers, rumination, self-reflection, poor attention and poor decision-making. However, only a handful of studies investigated the brain stimulation targeting DMPFC and the further changes in brain functional connectivity. The clinical efficacy and the fMRI changes of prolonged intermittent theta-burst stimulation (piTBS) and 20Hz- rTMS targeting bilateral DMPFC were investigated, and the predictive value of baseline networks by fMRI for antidepressant responses was also assessed to find a reliable approach to gauge treatment response prospectively.

NCT ID: NCT05411302 Recruiting - Clinical trials for Major Depressive Disorder

Augmenting Mental Health Support Through a Supportive Text Messaging Program

Text4Support
Start date: October 3, 2022
Phase: N/A
Study type: Interventional

Patients seeking mental health care and those being discharged from psychiatric units frequently express psychological distress. A lack of routine follow-up and tailored support during these critical stages of a patient's journey can weaken the patient's connection to the health care system, resulting in low adherence and dissatisfaction with treatment, and the need for more intensive therapies. These unfavourable outcomes may result in deterioration of the patient's mental health, readmissions, recurrent emergency department (ED) visits, and extended length of stay (LOS). The investigators propose implementing an add-on supportive text messaging service (Text4Support), developed using cognitive-behavioural therapy (CBT) principles to augment mental health support for patients accessing different degrees of psychiatric care in Nova Scotia. The primary objective is to investigate the effectiveness of Text4Support, compared to usual care, in improving clinical mental health outcomes and overall mental wellbeing among participants. Secondary objective is to examine the impact of Text4Support on health services utilization and patient satisfaction. Lastly, investigators will explore Text4Support implementation outcomes. This will be a multicenter, mixed-methods, longitudinal, prospective, parallel, two-arm, rater-blinded randomized controlled trial. Participants will be randomized into two arms: the intervention arm will receive the usual care, plus daily automated supportive text messages from an online application, and the control arm will receive the usual care, which includes the freely accessible Health Authority approved e-mental health services. It is planned to enrol at least 1500 participants. Quantitative data will be analyzed using repeated measures mixed-effects modelling, effect size analysis, and correlational analysis between measures at each time point on an intention-to-treat basis. Qualitative data analysis will be guided by the six-phase thematic analysis framework. The analysis of the implementation outcomes will be guided by the RE-AIM framework. The results of the study will provide important information with respect to a comprehensive evaluation of outcomes of a supportive daily text message program; comparability of a supportive daily text message program compared with care as usual; and the impact of a supportive daily text message program on clinical outcomes, patient satisfaction and health services utilization.

NCT ID: NCT05409794 Recruiting - Clinical trials for Major Depressive Disorder

Basal Plasma Lithium Levels and Suicidal Events

LIPS
Start date: December 9, 2022
Phase:
Study type: Observational

Suicidal behavior is a major public health issue and there are currently no specific treatments for it. However, lithium, the reference treatment for bipolar disorder, have been shown to be effective in preventing suicidal risk. Apart from drug treatments, lithium is present in our environment and its levels varies from one individual to another, depending, especially, on diet. Knowing that patients with a mood disorder generally have a poor lifestyle and a less rich and varied diet than the general population, variations in basal lithium levels can be expected in these patients.