Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-10-01
Completion: 2028-10-01
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The objective of this clinical trial is to evaluate the efficacy and safety of sertraline combined with multi-strain probiotics in adolescents aged 12-18 with major depressive disorder. The primary research question is whether sertraline combined with multi-strain probiotics is superior to sertraline combined with placebo in alleviating depressive symptoms and improving mood symptoms in adolescents. If there is a control group: researchers will compare sertraline combined with multi-strain probiotics with sertraline combined with placebo (a substance that looks similar but does not contain probiotics) to determine whether adding multi-strain probiotics provides greater therapeutic benefits for adolescent patients with depression. Participants will: 1. Undergo 8 weeks of treatment with sertraline combined with multi-strain probiotics or sertraline combined with placebo; 2. Have clinical visits every 4 weeks for clinical assessments and safety monitoring.
This study aims to examine the effects of music activities on depression and sleep quality among frail older adults, and to develop a standardized music activity protocol suitable for use in adult day care centers. A randomized controlled trial (RCT) design will be used. Participants will be recruited from 4 to 5 adult day care centers and randomly assigned to either an intervention group (receiving music activities twice per week, one hour per session, for eight weeks) or a control group (receiving only routine activities). Depression and sleep quality will be measured at baseline, week 4, and week 8. Assessments will include validated questionnaires and the index of osteoporotic fractures. Data analysis will evaluate the effectiveness of music activities in improving depression and enhancing sleep quality.
The purpose of this study is to evaluate a text message intervention called Essential Coaching for Every Mother in Tanzania to improve mothers' access to essential newborn care information during the immediate six-week postnatal period.
This study will use a randomized, double-blind clinical trial to evaluate the effects of eight-week HIIT and MICT exercise programs on cardiorespiratory fitness, the testosterone/cortisol ratio, and mental health in 68 healthy, moderately active young adults aged 18 to 21. Participants will be assigned to parallel groups based on their sex and training type (HIIT men, HIIT women, MICT men, MICT women). The key metrics will be measured both before and after the intervention period to assess the impact of the different training regimens.
The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. Subjects will attend the clinic every couple of weeks complete general health checks and complete questionnaires.
New challenges, stressors, and a loss of support often accompany the transition from adolescence to adulthood. Not surprisingly, transitional-aged youth (TAY) between the ages of 18-25 experience some of the highest rates of mental distress. However, access to mental health services diminish for TAY due to gaps in care when transitioning from pediatric to adult services. These challenges are exacerbated in rural communities, such as in Northwestern Ontario, where youth already access mental health services less frequently and face longer wait times than those in more urban areas. Limited access and extended waits can exacerbate symptoms, prolong distress, and increase the risk for adverse outcomes. Novel, innovative approaches are urgently needed to support TAY in Northwestern Ontario. In partnership with St. Joseph Care Group and Thunder Bay Counselling Centre, the investigators are evaluating the impact of a mental health app (JoyPop) as a tool for TAY waiting for mental health services. The JoyPop app was developed to support improved emotion regulation - a fundamental difficulty for youth presenting with mental health challenges. A two-arm randomized controlled trial (RCT) will be used to evaluate the effectiveness of the app compared to usual practice while TAY are waiting for mental health services.
In the brain, certain nerve cells communicate using a chemical called acetylcholine. Acetylcholine is thought to be important for several functions including mood, memory and wakefulness. The purpose of this study is to explore the role of these nerve cells in depression. Also, we would like to understand how nicotine, the study drug, works in depression and how it affects these nerve cells. To do this, brain imaging will be used before and after this treatment.
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
The importance and benefits of leading a physically active lifestyle have been long studied. Examples of the multiple advantages from physical activity are improved health of the heart and brain, having a more independent living and better quality of life. However, it is known that for many people, being active is challenging: physical activity is commonly viewed as a burden or inconvenience. In this study we will explore how some common everyday thoughts are hurdles to becoming physically active. We will discover ways to overcome this by using concepts from a field called "behavioral economics" that explains how we make decisions. The purpose of the program is to support participants in being more physically active. The study program is a newly developed way to overcome the intuitive preference for being sedentary. The experimental groups will learn simple ways to overcome expected hurdles in making decisions related to physical activity (the newly developed program), and the control groups will learn about the health benefits of physical activity and the health guidelines (the common practice today). We will compare the effectiveness of the newly developed intervention in promoting an active lifestyle, compared to the common practice today, of providing the knowledge and the recommended guidelines. The program in the study will be in small groups of 5-10 participants that will meet at The Royal for 60 minutes, twice a week, for 4 weeks.
Low mood and anhedonia represent the fundamental symptoms of major depressive disorder (MDD). Nevertheless, there is currently no standardized visual analogue scale available to assess the extent of both symptoms concurrently. The Maudsley 3-item Visual Analogue Scale (M3VAS) is a newly developed tool for participants to self-assess core symptoms of depression: mood quality, pleasure experience (anhedonia), and suicidality. Despite suicidality not being a primary symptom, it is included due to its critical relevance to safety. Participants will be instructed to rate the intensity and frequency of their experiences over the preceding two weeks by marking a 100 mm ungraded line. A researcher will then assign a numerical value based on the mark's position, utilizing the left edge as 0 and the right as 100. The total score range, combining the three symptoms, ranged from 0 (minimum) to 300 (maximum). The M3VAS exhibited good psychometric properties in British population. In this study, the objective is to assess the psychometric properties of the scale within the Polish population diagnosed with major depressive episode within major depressive disorder or bipolar disorder.
Depression is a leading cause of disability worldwide and is more commonly seen in individual's post-spinal cord injury (SCI) than in the general population. Depression post-SCI impacts an individuals' quality of life and recovery. It has been reported that among Veterans with an SCI, those without depression live longer than those with depression. Thus, depression must be treated appropriately. Repetitive transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression, but dosing is based on a motor response or movement in the thumb. Over half of individuals with SCI have some degree of arm or hand impairment, so these individuals might not be eligible for rTMS, or they may receive the wrong dose. This study proposes clinical trial in individuals with depression post-SCI to assess the anti-depressant effect of a novel technique to dose rTMS that does not require a motor response in the thumb. By gaining a better understanding of the application of rTMS for depression post-SCI, the investigators aim to advance the rehabilitative care of Veterans.
This study aims to evaluate the effectiveness of school-based psychological interventions in improving stress resilience and coping skills among adolescents in rural China. The intervention seeks to reduce stress-related mental health symptoms, including depression, anxiety, and post-traumatic stress, measured using validated instruments such as the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Child PTSD Symptom Scale for DSM-5 (CPSS-5). (See Appendix for full scale descriptions.) Participants will be recruited from rural middle schools and randomly assigned to either an intervention group or a wait-list control group. The intervention consists of four sessions delivered over one week. Assessments will be conducted at baseline, immediately after the intervention, and again at a 3-month and 6-month follow-ups. Researchers will use multilevel modeling (MLM) and structural equation modeling (SEM) to examine potential mediators and moderators of intervention effects, including emotion recognition, alexithymia, and coping strategies. indings are expected to provide evidence on the effectiveness and mechanisms of an existing, school-based psychological intervention tailored to the needs of adolescents in underserved rural settings.
The purpose of this study is to assess the efficacy of a Mediterranean diet on the function of the vagal nerve in patients with depression.
Decision-making is an important process that is frequently shown to be impaired in patients with depression. While a number of preclinical and clinical studies have identified key regions involved in this process, it remains unclear exactly how these regions are influencing choice behavior especially when choices become more challenging. The goal of this project is to understand how these regions, such as the cingulate cortex, impact difficult choice behavior. Specifically, the researchers are interested in learning how disruptions in cognitive control might impact choice preferences during difficult decisions in depressed patients. To do this, this study will recruit participants with depression (as well as healthy controls) to perform game-like tasks in the laboratory while undergoing TMS or TI.
Low self-efficacy is a transdiagnostic risk factor for several mental disorders. Self-efficacy refers to one's belief that one is capable of performing a behavior necessary to successfully complete a task or achieve a goal. Consistent with theoretical models and empirical findings, individuals with low self-efficacy are more likely to perceive challenges as uncontrollable and threatening and thus are at increased risk for developing mental disorders during sensitive periods such as young adulthood. Self-efficacy interventions have been shown to be effective in promoting health behavior change, quality of life, and treatment adherence in patients with serious illnesses, as well as motivation and performance in students and employees. However, whether targeted self-efficacy training can prospectively prevent the onset of full-threshold anxiety, affective, and substance use disorders in young adults at increased risk for psychopathology remains an open question. The aim of this randomized controlled trial is to test whether a brief cognitive-behavioral intervention in young adults with low self-efficacy can increase general self-efficacy (primary outcome of intervention effectiveness) and thus prevent the onset of DSM-5 mental disorders in the subsequent year (primary outcome of prevention effectiveness). In addition, we examine whether improvements in domain-specific self-efficacy lead to subsequent improvements in general self-efficacy and thus to lower psychopathological symptoms (spillover effects). Young adults (18-30 years) with low self-efficacy but no mental disorder will be included (N=378). The study will include screening, entry, baseline, post, and 12-month follow-up assessments plus additional course assessments in both groups. After the baseline assessment, participants will be randomized to an intervention or control group. The intervention group will receive group-based self-efficacy training (6 sessions of 75-90 minutes each). The control group will also meet in groups (6 sessions) but will only talk about psychological research findings unrelated to self-efficacy or cognitive-behavioral interventions without receiving any training. DSM-5 mental disorders will be assessed at study entry and follow-up with a structured diagnostic interview. Other outcomes will be assessed with established scales and ecological momentary assessments (EMA) at baseline, post and follow-up. Clinical outcomes include psychopathological symptoms (dimensional scores for anxiety, depression, anger, and somatic symptoms, as well as sleep disturbance) and mental disorders (DSM-5 categorical diagnoses of anxiety, affective, and substance use disorders). Intervention effectiveness will be tested using logistic/linear regression and multilevel analyses. Spillover effects between improvements in domain-specific/general self-efficacy and psychopathological symptoms over the course of the study will be examined using cross-lagged panel models.
This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.
The goal of this clinical trial is to evaluate whether EEG-based neurofeedback targeting the emotion regulation network through swLORETA can improve emotional regulation and reduce symptoms in adults with Major Depressive Disorder (MDD) who have not responded sufficiently to first-line treatments. The main questions it aims to answer are: * Does EEG-neurofeedback improve emotional self-regulation and reduce clinical symptoms in patients with MDD with or without anxiety symptoms? * Are changes in EEG resting-state activity and stress biomarkers (e.g., cortisol) associated with clinical improvement? Researchers will compare an active neurofeedback group, a sham (placebo) neurofeedback group, and a treatment-as-usual control group to see if real-time EEG-neurofeedback leads to greater improvement in mood, emotional regulation, and neurophysiological indicators than placebo or no additional intervention. Participants will: * Receive 10 sessions of either real or sham EEG-neurofeedback (or no sessions in the control group) over 5 weeks. * Complete clinical, psychological, and neurophysiological assessments before (week 0) and after the intervention (week 6). * Provide repeated saliva samples to assess stress-related biomarkers at week 0 and week 6. * Continue their standard pharmacological treatment throughout the study.
This is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.
This study is a stratified, parallel-group, single-center study utilizing multimodal imaging techniques to identify biomarkers for Major Depressive Disorder (MDD). The study goal is to identify biomarkers for MDD and treatment response that can be implemented in clinical diagnosis and care as valid and reliable measures, through monitoring neurophysiological and electrophysiological changes across the course of transcranial magnetic stimulation (TMS) treatment.
This study evaluates the association between testosterone levels and risk of dementia and adverse mental health outcomes (e.g. depression and anxiety). It is not known whether low testosterone levels may be associated with an increased risk of dementia. Learning about the association between testosterone levels and risk of dementia may help determine the long-term effects of androgen deprivation therapy and may help improve quality of life.