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Depressive Episode clinical trials

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NCT ID: NCT06152705 Recruiting - Depression Clinical Trials

Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression

Start date: June 10, 2024
Phase: N/A
Study type: Interventional

In this triple-blind randomized controlled trial, we ask if targeting intermittent theta burst stimulation (iTBS) based on individual resting state connectivity improves treatment outcomes in major depressive disorder (MDD). For the trial, we will recruit 210 patients with major depressive disorder. Each patient will undergo a 30-40-minute MRI scan, after which they will receive a 6-week standard iTBS treatment. Participants will be randomized to receive iTBS either to the standard neuronavigated target (a technique for treatment location targeting, based on group-average connectivity) or to a personalized connectivity-guided target selected based on individual functional connectivity scans. The main outcome of this trial is response rate as determined by ≥ 50% reduction in Grid HRSD-17 scores. Secondary outcomes include remission rate, change in depression, anxiety and anhedonia symptoms, quality of life, and biological measures of heart rate variability, objective sleep measures and daily activity as a proxy of anhedonia - defined as a reduced ability to experience pleasure.

NCT ID: NCT05910775 Recruiting - Depressive Episode Clinical Trials

Role Of Non-Specific Effects in The Treatment of Depression With Esketamine

ROSETTE
Start date: May 3, 2024
Phase: N/A
Study type: Interventional

The investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment follow up session, to assess whether nonspecific effects can be used effectively to improve the effectiveness of treatment with esketamine.

NCT ID: NCT05708222 Recruiting - Depression Clinical Trials

Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)

SAMDE
Start date: September 1, 2022
Phase:
Study type: Observational

The objective of this study is to collect data to finalize the development of MEB-001 software as a medical device. The data collected in this study will be used to develop MEB-001 machine learning algorithms by training the algorithms to match the patient's demographic and clinical information, and the objective physiological signals (i.e., electroencephalogram (EEG) and electrocardiogram (ECG)) recorded during PSG with the diagnosis of cMDE performed through the MINI neuropsychiatric evaluation.

NCT ID: NCT05691647 Recruiting - Depressive Episode Clinical Trials

Chronotherapy for Depressive Episodes

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

Evidence-based treatments for depression, such as antidepressive medication, usually have a latency of 4 to 6 weeks before they achieve a therapeutic effect. Chronotherapy is a group of non-pharmacological interventions that presumably act on the circadian system to achieve a rapid-onset clinical effect and better long-term effects and has been shown efficient to improve depressive symptoms. Interventions include sleep deprivation, sleep-phase advancement and stabilization, and light therapy. There are few studies testing the effectiveness of combining these three chronotherapeutic techniques in the initial phase of treatment of depression in a secondary mental health care outpatient clinic. The investigators aim to test the effects and safety of chronotherapy in addition to TAU compared to TAU alone, with the primary outcome being self-reported depressive symptoms at 1 week following randomization. The study is a randomized controlled trial with 76 patients with a depressive episode who initiate outpatient treatment at Nidaros DPS, St. Olavs University Hospital. Participants will be allocated 1:1 to either chronotherapy + treatment as usual (TAU) or to TAU alone.

NCT ID: NCT05654948 Recruiting - Depressive Episode Clinical Trials

Characterisation of Fundamental Decision Making in People Suffering From a Characterised Depressive Episode

MINDDE
Start date: February 9, 2023
Phase:
Study type: Observational

The investigators will include patients suffering from Major Depressive Disorder (MDD), in episode. The patients will undertake neuropsychological tasks evaluating executive function and clinical assessment related to depressive symptoms, anxiety, transdiagnostic symptoms and psychological skills.

NCT ID: NCT05641623 Recruiting - Depression Clinical Trials

OSU6162 as add-on in SSRI/SNRI-resistant Depression

ODEN
Start date: April 21, 2022
Phase: Phase 2
Study type: Interventional

This is a randomised, placebo-controlled, parallel-group trial comparing OSU6162 at flexible dosage with placebo as add-on to treatment with an SSRI/SNRI in patients with depression that have not responded to treatment with an SSRI/SNRI per se for at least 6 weeks. The study will last for 6 weeks, after which those not having responded will leave the trial and those having responded will be offered to continue treatment without unblinding for another 4 weeks. While assessment of the efficacy and safety of OSU6162 is the main objective of this study, possible differences between the two treatment groups with respect to a number of biomarkers in serum will also be explored. Multicenter trial: Multiple sites four Gothenburg, Lund, Stockholm and Uppsala.

NCT ID: NCT04990401 Recruiting - Depression Clinical Trials

Behavioral Activation Teletherapy to Increase Physical Activity

BAT
Start date: August 31, 2021
Phase: N/A
Study type: Interventional

This is a pilot study of acceptability, feasibility, and preliminary efficacy of a brief, 10-session Behavioral Activation intervention delivered via teletherapy to increase physical activity and treat depressive symptoms.

NCT ID: NCT04572321 Recruiting - Depression Clinical Trials

Youth Depression and Suicide Research Network

YDSRN
Start date: August 26, 2020
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to build the Texas Youth Depression and Suicide Research Network to support the development of a Network Participant Registry and characterization of systems and interventions to examine statewide population health outcomes. All 12-13 sites represented in the Texas Child Mental Health Care Consortium (https://www.utsystem.edu/pophealth/tcmhcc/) have been invited to participate in the Texas Youth Depression and Suicide Research Network as "Nodes." 12 Nodes have been selected for this project. Each Node has obtained support of senior institutional leadership including the department chair. Leadership from each Node provided input and edits in the study design process by committee, with a focus on the inclusion of the "end user" in design decisions. Nodes will work closely with the Network Hub leadership to recruit, monitor, and retain participants. This will require active engagement and sustained relationships with clinics within the academic medical center as well as clinics in the community (i.e., psychiatry, psychology, counselling).

NCT ID: NCT04123301 Recruiting - Bipolar Disorder Clinical Trials

Theta-Burst Stimulation in Major Depressive Episodes With Mixed Characteristics.

Start date: March 8, 2019
Phase: N/A
Study type: Interventional

The investigators will perform a double-blind, randomized, sham-controlled clinical trial of theta-burst stimulation (TBS) in mixed depressive episodes of both bipolar and major depressive disorders. Will be selected 90 patients aged 18-65 years with diagnosis of TB (I or II) or MDD in moderate or severe major depressive episode with mixed features. The primary endpoint of efficacy will be a continuous outcome of change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 3.

NCT ID: NCT03944213 Recruiting - Depression Clinical Trials

Resting-state Functional Connectivity Throughout a Course of iTBS in Major Depression

Start date: July 23, 2018
Phase:
Study type: Observational

This study aims to investigate changes in functional connectivity over a four week treatment course with intermittent theta burst stimulation (iTBS) in patients with major depressive disorder (MDD). To this end, seven weekly resting-state fMRI (rs-fMRI) scans at 7 tesla (7T) will precede, accompany and follow the iTBS treatment course. By obtaining several samples of the modulatory effects of iTBS on functional connectivity networks and simultaneous measurements of the depressive symptoms it will be possible to assess the time course of changes in connectivity across different networks, and to assess the overall relationship between the network modulation and the antidepressant effects of the treatment over time.