The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments...
Major Depressive Disorder 1Major Depressive Disorder1 moreThe study will apply state of the art radiology through advanced magnetic resonance imaging (MRI) techniques to investigate structural and functional brain effects of electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS).
The Role of Neuromodulation Technique In Depression Disorder
Depressive DisorderMajorThis study aims to explore the efficacy, safety and long-term effects of common and available non-invasive neuromodulation techniques in the treatment of depression, and to provide a data basis for the establishment of individualized treatment and efficacy prediction models. 450 patients will be enrolled and randomly assigned to five different treatments. Psychopathological assessment will be performed in both acute and maintenance phases of treatment with the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Patient Health Questionaire-9, the Sheehan Disability Scale, the Vascular Quality of Life-6 Questionnaire respectively.
RIVER At Home Ketamine Protocols
Chronic ConditionChronic Pain4 moreMultiple site studies with the recruitment of other sub-investigators and sites. It's sobering to consider how chronic illness makes us more vulnerable to suicidal thoughts and behavior. However, the existence of multiple risk factors also means that there are numerous ways to intervene. Addressing and improving even one risk area will reverberate and improve other areas and the quality of life. RIVER Foundation is completing a 500-participant pilot study researching the safety of oral and nasal ketamine at home with no therapy. The pilot study examined three psychological scales: P.H.Q. 9, G.A.D. 7, and PCL5 scores. The interim report will be available in Nov 2023 with a final report in June 2024. The lack of knowledge for the average medical practitioner makes ketamine a boutique medicine, often costly and unaffordable to those in need. Yet daily medical providers are eliminating ketamine as a choice in the treatment of chronic conditions. The pilot study demonstrated the who, and where. The who, was adults with a chronic condition. The pilot study demonstrated the majority of those who could use ketamine are not receiving it due to cost. According to the 500-participant study, ketamine is safe and effective for at-home use thus demonstrating the where (at home with no supervision).
Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder
Major Depressive DisorderThis randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of NMRA-335140 (formerly BTRX-335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 28 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an open-label extension study (NMRA-335140-501).
Positive Processes and Transition to Health (PATH)
Posttraumatic Stress DisorderMajor Depressive DisorderThe R33 will be a randomized controlled trial to replicate changes in the targets (unproductive processing, avoidance, reward deficits) from the R61 phase in a larger sample of 135 participants who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, this study will examine Positive Processes and Transition to Health (PATH)'s impact on stressor-related psychopathology in comparison to Progressive Muscle Relaxation (PMR). In the R33 phase, we will examine changes in target mechanisms predicting improvements in PTSD and depressive symptoms, as well as feasibility and acceptability. Patients will receive 6 sessions of PATH or PMR (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 3, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.
Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults With PTSD
PTSDGeneralized Anxiety Disorder1 moreThe aim of this study is to obtain data on the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms. The study will also collect data on Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD) to aid in assessing the presence and severity of these disorders both for the purpose of discerning them from PTSD and determining the feasibility of diagnosing them independently.
Brain Network Dynamics of Depression During Esketamine Treatment
Depressive DisorderMajorThis is a monocentric, observational clinical trial investigating the effect of Esketamine on brain network activity and a belief updating task in people with depression. We investigate the immediate and the long-term effect (approx. 8 weeks) of Esketamine on EEG signals, pupillometry and belief updating and the relation of those effects on depressive symptomatology.
Metabolomics During ElectroConvulsivoTherapy
Major Depressive EpisodeECTInvestigators will measure the variation of blood Metabolome through 1H NMR at several time points during the course of electroconvulsivetherapy in patients with a major depressive episode. Patients with a major depressive disorder or a bipolar disorder and a current major depressive episode will be included in this study. Investigators hypothesized that Metabolome could be a source to predict response during ECT and to help understanding underlying biological mechanisms.
pBFS Guided 20min Inter-session Interval rTMS Treatment for MDD
Moderate DepressionMajor Depressive Disorder1 moreThe investigators aim to explore the efficacy and safety of rTMS therapies with different intervals between sessions for treating patients with moderate to severe depression.
Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)
Major Depressive DisorderThe investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).