DIfferential Feasibility and Tolerability of Deep repetitiVe transcranIal MagNEtic Stimulation for Depression in Older Adults (DIVINE Trial): A Pilot Study
This study aims to: (1) assess the feasibility and tolerability of two active dTMS coils - H4 and H7 - in older adults with depression; and (2) clinical response measured by change from baseline on the Hamilton Depression Rating Scale- 24 item; changes in cognitive function through neuropsychological assessment; and changes in regional electrophysiological activity and functional connectivity indexed by EEG. Through a parallel design, participants will complete a four-week course of five dTMS sessions per week, for a total of 20 stimulation sessions. Participants will be randomly assigned to either coil (H4 or H7) and will complete questionnaires examining side effects, mental health symptoms, and cognition. Participant EEG data will be measured and collected at baseline and at the end of each week. Collectively, the study will address the absolute and differential feasibility and tolerability of the two active coils to provide preliminary data for a future randomized controlled trial comparing one or both of these novel interventions to the established H1-coil and a sham stimulation (placebo) control.
NCT05855850 — Major Depressive Disorder
Status: Completed
http://inclinicaltrials.com/major-depressive-disorder/NCT05855850/
Efficacy and Safety of Auricular Acupuncture in Depression During the Covid 19 Pandemic: a Multicenter Triple-blinded Randomized Clinical Trial
Participants with moderate depressive symptoms measured by PHQ-9 will be randomized to receive auricular acupuncture. The triple blinded procedure will be conducted in 12 sessions (6 weeks). The primary outcome is the response to the treatment 3 months after inclusion.
NCT05855421 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05855421/
The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients
The goal of this pilot study is to learn about the feasibility about prescribing anti-depressants at discharge in patients aged 50 years and older with a lower extremity fragility fracture. The main questions it aims to answer are: - What are the obstacles to enrolling patients and prescribing anti-depressants among older adults? - Is it possible to start prescribing SNRI medication upon discharge? - What is the prevalence of depressive symptoms amongst patients with different types of injuries and weightbearing status? - What is a transition of care plan for patients who have geriatric depression and require further care? Participants will: - Undergo screening using the Geriatric Depression Scale - Start on Duloxetine 30mg daily at time of discharge - Report medication compliance and complete re-screening monthly - Complete patient reported outcome measures and 3 months, 6 months, and 1 year - Receive a referral to behavioral health, primary care, or psychiatrist for evaluation if they screen positive at any timepoint
NCT05851898 — Depression in Old Age
Status: Recruiting
http://inclinicaltrials.com/depression-in-old-age/NCT05851898/
Disentangling the Role of Depression in Hypersomnia
Individuals who have disorders of hypersomnolence (excessive sleepiness) often report symptoms of depression. The goal of this study is to further understand of the relationship between depression and hypersomnia by examining mood-relevant domains of slow wave sleep and reward function.
NCT05850676 — Hypersomnia
Status: Recruiting
http://inclinicaltrials.com/hypersomnia/NCT05850676/
A Prospective, Double-blind, Randomized Controlled Trial of FMT Combined With Antidepressants to Improve the Efficacy in Patients With Depressive Disorder
Patients with depression were enrolled and randomly divided into two groups, namely FMT combined with antidepressant group and Antidepressant alone group.The former received FMT capsules and antidepressants, and the latter received oral placebo and antidepressants for an 8-week intervention.Before and after intervention, venous blood samples were collected from patients for routine tests such as liver and kidney function to judge the safety of treatment. At the same time, psychological scales were used to evaluate the improvement of patients' depressive symptoms, so as to judge the efficacy and safety of FMT combined with antidepressants.
NCT05850572 — Depression
Status: Not yet recruiting
http://inclinicaltrials.com/depression/NCT05850572/
Internet-based Physical Activities Randomized Controlled Trial in Patients With Mild/Moderate Depression: Effects on Psychological and Social Well-being: SONRIE Project
The goal of this randomized controlled trial is to determine the effect of an intervention program with physical activity for 12 weeks on depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression. The main questions it aims to answer are: 1. - To determine the association of physical activity levels, sedentary behavior, sleep patterns, physical condition, diet, and general health status with mental and social well-being, and quality of life in a large sample of adult patients diagnosed with mild or moderate depression. 2. - To examine the predictive capacity of physical activity, sedentary behaviors, and physical condition on mild and moderate depressive disorder. 3. - To study the effect of a period without an intervention program with physical activity (8 weeks without exercise intervention) on the variables studied. 4. - To examine the role of the endocannabinoid system on depression as well as its behavior after an intervention program of physical activity. Participants will be involved in a physical activity intervention program for 12 weeks. Researchers will compare intervention group and control group to see if an intervention program with physical activity for 12 weeks improve depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression.
NCT05849792 — Depression
Status: Completed
http://inclinicaltrials.com/depression/NCT05849792/
Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
The purpose of this study is to investigate the effectiveness of accelerated intermittent theta-burst transcranial magnetic stimulation (aiTBS) in inducing anti-depressant responses in individuals with treatment-resistant depression of bipolar II disorder. This is a double-blind, randomized, sham-controlled trial that targets a single location on the left dorsolateral prefrontal cortex (LDLPFC) using the MagPro rTMS system.
NCT05849402 — Treatment Resistant Depression
Status: Recruiting
http://inclinicaltrials.com/treatment-resistant-depression/NCT05849402/
Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression: a Prospective, Single-arm, Multicenter Study
The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of somatic symptoms in depression, to provide evidence-based basis for clinical rational drug use.
NCT05849272 — Somatic Symptom
Status: Not yet recruiting
http://inclinicaltrials.com/somatic-symptom/NCT05849272/
The Role of Inflammation in Central Nervous System (CNS) Mechanisms of Anhedonia and Psychomotor Slowing in Depressed People With HIV
The purpose of this 10-week, double-blind, placebo-controlled study is to determine whether inflammation impacts reward and motor neural circuitry to contribute to depressive symptoms like anhedonia and psychomotor slowing in people with Human Immunodeficiency Virus (HIV) and depression. Sixty male and female patients with HIV who have depression, anhedonia and high inflammation and are stable on effective treatment for their HIV will be randomized to receive either the anti-inflammatory drug baricitinib or a placebo for 10 weeks. Participants will complete lab tests, medical and psychiatric assessments, neurocognitive testing, functional MRI (fMRI) scans, and optional spinal taps as part of the study. The total length of participation is about 5 months.
NCT05849038 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05849038/
The NutriMind Trial: A Low-cost Randomized Trial Combining a Healthy Diet and Psychotherapy to Treat Depressive Symptoms Among University Students - The Case of Uganda
University students in Low- and Middle-Income Countries (LMIC) continue to face growing rates of depression, a common mental health problem. Adding to this burden is the mental health treatment gap, necessitating the need to identify new treatment methods that can easily be implemented at a large scale. This project will test if a healthy diet combined with mindfulness-based cognitive therapy can reduce depressive symptoms among university students in Uganda, a low resource country. The burden of depression is high in sub-Saharan African countries, largely worsened by poverty, hunger and poor public health service, and lately the COVID-19 pandemic. These factors increase psychological distress among young people in sensitive periods of life, such as students who are about to choose their career and establish family. Successfully managing depression in LMIC is likely to depend on low-cost treatment that can easily be managed to large target populations, yet still be at the scientific forefront, proof-based, and culturally acceptable. This can possibly be obtained with an intervention combining healthy diet and cognitive behavioral therapy based on mindfulness principles. While healthy diets and mindfulness cognitive therapy individually can partly lessen the burden of depression, these two therapeutic modalities have not been tested in combination among university students in sub-Saharan Africa, i.e. a synergistic effect that is still to be studied. With the NutriMind Trial, its investigators focus on a neglected global mental health challenge, namely depression among university students in Uganda.
NCT05848973 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05848973/