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Depressive Disorder clinical trials

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NCT ID: NCT05778643 Recruiting - Clinical trials for Major Depressive Disorder

TaKeTiNa in the Treatment of Depression: a Pilot Study.

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical study's to analyse the impact of TaKeTiNa music therapy in depressed patients. The main question[s] it aims to answer are: . Can TaKeTiNa result in a significant pre-to-post intervention decline of depression severity 2. Can TaKeTiNa result in a significantly lower post-intervention depression severity in the T1/T2 group than in the W1/W2 group. Participants will - be randomly assigned to the two groups, intervention vs. waitlist - receive either an eight week TaKeTiNa music therapy or waitlist - be analysed using questionaires, blood taking, cortisol saliva analysis, measured heart rate variability Researchers will compare a waitlist to see if TakeTiNa is superior to waitlist

NCT ID: NCT05777876 Recruiting - Clinical trials for Treatment-Resistant Depression

Early Identification of TRD and Construction and Clinical Validation of NTBS Precision Technology

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the characteristics, identify early and intervene effectively in time in Treatment-Resistant Depression. The main questions are: • TRD is difficult to identify early and lacks objective detection indicators; • Existing treatment strategies for TRD are associated with side effects and high treatment resistance; • Current non-invasive brain stimulation therapy lacks precision. it aims to answer are: • Construct a multimodal TRD early identification model based on clinical characteristics, blood factors, functional magnetic resonance and brain electrophysiological indicators; • Develop non-invasive transcranial deep brain stimulation technology based on focused electric field; • In TRD patients, an individualized non-invasive transcranial deep electrical stimulation technology based on precise magnetic resonance targets and EEG phase guidance was constructed. Participants will:• be collected data multiple times including clinical symptoms, peripheral biology, functional magnetic resonance, electrophysiology and other clinical data before and after the intervention; • receive non-invasive transcranial deep brain stimulation or sham stimulation of different deep brain target points; • be collected EEG data while receiving stimulation. Researchers will • compare the biological characteristics of TRD, n-TRD patients and health controls to build early identification models and find potential spatial and temporal intervention targets dependent on TRD status; • verify the safety of non-invasive transcranial deep brain stimulation device in health controls; • compare TRD with different modes of stimulation to find the best treatment plan for non-invasive transcranial deep brain stimulation and verify safety.

NCT ID: NCT05773755 Recruiting - Clinical trials for Major Depressive Disorder

DBS for TRD With the Medtronic Percept PC

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Of the estimated 30 million Americans who suffer from Major Depressive Disorder, approximately 10% are considered treatment resistant. Deep brain stimulation (DBS) to a region of the brain called the subcallosal cingulate (SCC) is an emerging strategy for treatment resistant depression (TRD), which involves placement of electrodes in a specific region of the brain and stimulating that area with electricity. This is believed to reset the brain network responsible for symptoms and results in a significant antidepressant response. A series of open-label studies have demonstrated sustained, long-term antidepressant effects in 40-60% of patients who received this treatment. A challenge to the effective dissemination of this fledgling treatment is the absence of biomarkers (objective, measureable indications of the state of the body and brain) to guide device placement and select stimulation parameters during follow-up care. By using a DBS device called the Percept PC (Medtronic, Inc) which has the ability to both deliver stimulation to and record electrical signals directly from the brain, this study aims to identify changes in local field potentials (LFPs), specific electrical signals that are thought to represent how the brain communicates information from one region to another, to see how this relates to DBS parameter settings and patient depressive symptomatology. The goal of this study is to study LFPs before and during active DBS stimulation to identify changes that correlate with the antidepressant effects of SCC DBS. The study team will recruit 10 patients with TRD and implant them with the Percept PC system. Participants will be asked to complete short questionnaires and collect LFP data twice daily for the first year of the study, as well as have weekly in person research procedures and assessments with the study team for up to one year. These include meetings with the study psychiatrist, psychologist, symptom ratings, and movement, voice, and video recordings. A brief discontinuation experiment will be conducted after 6 months of stimulation, in which the stimulation will be turned off and patterns of LFP changes will be recorded. The entire study is expected to last about 5 years, parcellated into several study phases. All participants are required to live in the New York metropolitan area for the first several months of the study.

NCT ID: NCT05772897 Recruiting - Clinical trials for Postpartum Depression

Parenting Skills Group for Mothers With Postpartum Depression

Start date: August 3, 2023
Phase: N/A
Study type: Interventional

The goal of this longitudinal study is to study the effects of a parenting skills group (Circle of Security Parenting, aka COSP) in mothers with postpartum depression. The main questions it aims to answer are: - Will changes in methylation of the OXTR rs53576 be apparent in mother and/or infant after having gone through the 8-week COSP program? - Will COSP participation be associated with improved symptoms of postpartum depression (over and above standard care), attachment style, and relational characteristics of the mother-infant dyad? - Will COSP participation be associated with changes in social behavior in the infant, and if so, do they persist throughout childhood? Participants will - Participate in an 8-week COSP program delivered remotely via Zoom. - Provide buccal swabs (mother and infant) to assess changes in methylation of OXTR rs53576 pre- versus post-intervention. - Complete a series of assessment questionnaires delivered remotely. - Videotape a play-based assessment in their home. - Receive infant developmental testing Researchers will compare characteristics of waitlist controls to those participating in the COSP program at the mid-way point of the program to see if the two groups differ.

NCT ID: NCT05772702 Recruiting - Depression Clinical Trials

Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression

CLACS
Start date: February 13, 2023
Phase: N/A
Study type: Interventional

The purpose of this research study is to study closed-loop transcranial alternating current stimulation (tACS) to determine its effects on symptoms of depression in people with major depressive disorder.

NCT ID: NCT05772221 Recruiting - Clinical trials for Cardiovascular Diseases

The Role of Social Determinants in Cardiovascular Health and Vascular Function

CVRRC
Start date: June 29, 2023
Phase: N/A
Study type: Interventional

This study aims to identify the influence of social determinants of health domains on vascular function in a low income, racial, and ethnic minority population at risk for disparities. We hypothesize that individuals of a lower social economic position and those struggling with depression are at greater risk of cardiovascular disease.

NCT ID: NCT05768126 Recruiting - Depressive Disorder Clinical Trials

Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine

PRECISER
Start date: September 29, 2021
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to test the beneficial effects of rivastigmine administration, and predict the treatment outcome with electroencephalography (EEG), in patients with severe depression treated with electroconvulsive therapy (ECT). The study has two main objectives: - to study whether rivastigmine would ameliorate the side-effect profile of ECT - to develop an outcome prediction model based on resting state EEG for both the response to treatment as well as its side effect Participants will be assessed by: - Cognitive tests - Questionnaires of clinical symptoms - Questionnaires of depressive symptoms - Bloodsample - Resting state and task-based EEG Researchers will compare patients with a depressive disorder treated with ECT receiving rivastigmine to placebo patches to see if rivastigmine reduces cognitive side effects.

NCT ID: NCT05767593 Recruiting - Clinical trials for Major Depressive Disorder

Clinical Validation of Samsung Smartwatch

Start date: March 13, 2023
Phase:
Study type: Observational

Objective: Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily understood visual index of mental health. The primary aim of the study is to evaluate the performance of Samsung's Mindfulness Index in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) from a clinician-administered semi-structured diagnostic interview. Research Procedures: The target sample size is 75 individuals diagnosed with current Major Depressive Disorder and 75 healthy controls. To meet this target, the recruitment target is set at 215 participants. Participants will be assigned to the MDD condition, or the healthy control condition based on their score on the Beck Depression Inventory. Each subject will be followed for 3 months. Participants will be provided with a Samsung smartphone and Samsung smartwatch. Participants will be asked to wear the smartwatch 24 hours per day, except while charging. This smartwatch will collect data on heartrate, sleep time, and step count. During the study, each day participants will receive texts prompting a link to a "daily diary." These surveys will ask about depression and anxiety symptoms. Additionally, during the first 3 weeks of the study, participants will participate in ecological momentary assessment; texts will be sent 5 times per day prompting participants to fill out a survey about how they currently feel in that moment. These extra surveys will stop after the first 3 weeks of the study, but the daily diary surveys will continue throughout the study. Furthermore, virtual clinician visits will occur at weeks 4, 8, and 12.

NCT ID: NCT05767554 Recruiting - Depression Clinical Trials

Depression, Experiential Diversity, and Behavioral Novelty

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

The purpose of the study is to test whether changes in behavioral patterns are related to changes in depression. Depression is a psychological condition that involves persistent sad mood and/or an inability to enjoy pleasurable activities. Very stable behavioral patterns may be related to symptoms of depression. The aim of this study is to learn more about the relationship between symptoms of depression and behavioral patterns that are collected via GPS (global positioning system) location data from a smartphone.

NCT ID: NCT05767073 Recruiting - Clinical trials for Depression, Unipolar

LIVES: Personalized Lifestyle Intervention for Patients With Depression

LIVES
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Persons with affective disorder have a considerably increased risk of cardiovascular disease. To a considerable extent, this is due to an unhealthy life style. At present, no adequate lifestyle interventions are available for these patients. In the present pilot intervention study we study the acceptability and feasibility of a newly developed lifestyle intervention that is specifically tailored to the needs of patients with affective disorders treated in mental health care or general practice.