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Depressive Disorder, Major clinical trials

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NCT ID: NCT05217758 Recruiting - Clinical trials for Major Depressive Disorder

RESET-medication Glucocorticoid Receptor (GR) Blockade as Disease Modifying Treatment for Depression With Childhood Trauma

RESET-m
Start date: December 9, 2021
Phase: Phase 2
Study type: Interventional

Depression is a recurrent debilitating psychiatric disorder with a lifetime prevalence of 20%. Even though antidepressants and psychotherapy are often effective, a substantial proportion of patients does not respond to currently used evidence-based treatments. The heterogeneous nature of depressive symptoms is a major obstacle for the development of novel effective treatments, and targeted treatments for depression are currently lacking. The investigators propose a targeted disease-modifying treatment for the clinically distinct form of depression related to childhood trauma (CT, emotional/ physical/sexual abuse or neglect before the age of18). CT-related depression is critically different from non-CT depression: it emerges earlier in life with more severe and recurrent symptoms and less favorable responses to treatment. With an average 25% prevalence in depression, there is a large and unmet need for therapeutic strategies to treat depression in individuals with substantial CT. The GR is the major cortisol receptor in the brain and rodent studies have shown that GR blockade at adult age can reverse the effects of early-life adversity. Therefore, GR blockade is a potential novel treatment for CT-related depression but this has never been investigated. Based on the underlying stress neurobiology, the aim is to investigate whether the biological sequelae of excessive stress due to CT can be targeted by blocking the glucocorticoid receptor (GR) using the generic drug mifepristone.

NCT ID: NCT05212636 Completed - Clinical trials for Depressive Disorder, Major

Using Repetitive Transcranial Magnetic Stimulation to Study the Role of Frontostriatal Circuit in Major Depressive Disorder

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

Major depressive disorder (MDD) is a common, severe, and often life-threatening illness that involves the body, mood, and thoughts. The natural course of MDD tends to worsen without treatment, while people with MDD can lead healthy and productive lives when the illness is effectively treated. Up to 50% of the patients show no response to current available antidepressants.Two major non-invasive brain stimulation (NIBS) tools have been applied for the treatment of psychiatric diseases so far, transcranial magnetic and direct current stimulation (TMS, tDCS). TMS induces a strong magnetic field (magnetic pulses) through the skull into the brain, which generates electrical currents in brain tissue and induces neuronal firing, leading to after-effects, i.e. neuroplasticity, eventually. Neuronal effects of rTMS has been proven to last beyond the actual time of stimulation, enabling altered brain activity for an extended period of time. Adding on rTMS treatment could even give a chance to treat the physical comorbidities and enhance cognitive function in MDD. Nevertheless, underlying neurobiological mechanism of rTMS treatment remains unclear. Reports showed chronic psychosocial stressors are associated with altered frontal-striatal circuitry activation and connectivity. Indeed, aberrant fronto-striatal connectivity and reduced sustain fronto-striatal activation were noticed in MDD patients. However, the specific correlations between fronto-striatal connectivity changes and rTMS treatment outcomes in MDD remain unclear. In this study fMRI will be used to measure the possible correlations between the fronto-striatal circuit activation / connectivity with (1) mood symptoms presentations, (2) neurocognitive measurements, (3) HPA and ANS activities, and (4) immune and metabolic status (cytokines, adipokines and insulin levels) in patients with MDD. Then the possible changes in fronto-striatal FC over a four-week treatment course with 10 Hz rTMS stimulation to left dorsolateral prefrontal cortex will be measured. The FC changes will be tested to find out whether correlate with treatment outcomes, HPA and ANS activity; and immune/metabolic indices changes. We hypothesize that rTMS as an add-on therapy would change the fronto-striatal FC that correlated with mood symptom improvement, neurocognitive measurements, HPA and ANS activity, inflammatory and metabolic homeostasis in patients with MDD.

NCT ID: NCT05212389 Recruiting - Clinical trials for Major Depressive Disorder

The Pill Project - Oral Contraceptive and Serotonergic Brain Signaling

Start date: December 22, 2021
Phase: N/A
Study type: Interventional

Large register based work has shown that starting on oral contraceptives (OCs) is associated with an increased risk of developing depressive episodes. It is not known why this is, but changes in the serotonergic brain system might play a role. Intriguingly, in cross-sectional work, the investigators have demonstrated a lower level of the serotonin 4 receptor globally in the brain of healthy women using oral contraceptives compared to non-users. The order of magnitude of this difference is comparable to what has been observed in depressed individuals relative to healthy controls. In this study, the investigators will apply a longitudinal design to determine if starting on oral contraceptives induces a reduction in the serotonin 4 receptor in healthy women and whether such changes are related to potential changes in measures of cognition as well as mood/affect and sexual desire. The study is a single-blind randomized placebo-controlled trial with a 3-month intervention paradigm of either Femicept (2nd generation combined oral contraceptive) or placebo. The investigators will include participants until 20 women have completed the study in each arm. Participants will go through an investigational program, including PET and MR brain scans and neuropsychological testing, before starting on the treatment and again during the third pill cycle. To capture changes in mood/ and sexual desire, the participants will complete daily questionnaires during the baseline menstrual cycle and during third pill cycle. A linear latent variable model will be used to evaluate if OC use induces changes in the serotonin 4 receptor level and such changes will be correlated to changes in secondary outcomes (i.e., cognitive and psychometric measures).

NCT ID: NCT05211466 Active, not recruiting - Depression Clinical Trials

Digital Care Chains in Health Care - a Study of Care Consumption, Care Quality, Work Environment and Well-being

Start date: January 17, 2022
Phase:
Study type: Observational

Digital healthcare has developed rapidly to meet demands for accessible healthcare, streamline care and meet future challenges with increasing healthcare needs and reduced labour force in Sweden. Developers and stakeholders in Sweden want to exchange the praxis of phone triage to digital or semi-digital triaging tools, to relieve staff's workload and utilize better resource use that would benefit all patient groups. However, previous studies have showed demographic differences in utilization rate and an increase of simpler care matters when digital healthcare options are offered. Also, little is known of medical accuracy of digital triage tools and of the work environment in digital healthcare. More research is needed on this, as well as on care consumption, care quality and of patients' experiences of digital healthcare. The overall aim of the research project is to study a new digital healthcare platform being introduced in 2021/2022 in the County of Gävleborg, Sweden. The studies will focus on care consumption, healthcare outcomes, care quality and patient safety as well as explore the digital work environment in the digital healthcare platform. Data will be collected before and after the introduction of the digital healthcare platform, using register data and questionnaires. The data from the two time periods will be analyzed with descriptive and inference statistics, to explore if the digital healthcare platform has brought differences on group levels in care consumption, healthcare outcomes, care quality and patient safety as well as in work environment aspects such as the staffs' well-being.

NCT ID: NCT05210153 Recruiting - Clinical trials for Depressive Disorder, Major

Personalized Sertraline Dosing in Patients With Depression

PsyCise-S
Start date: July 16, 2020
Phase:
Study type: Observational

The aims of this study are to: 1. Determine the proportion of participants who are underdosed or overdosed under recommended dosing regimen of sertraline for the depression treatment (100 mg/day) 2. Determine and quantify clinical benefits of personalized sertraline dosing regimen based on the sertraline blood level monitoring 3. Retrospectively estimate whether the information on CYP2C19 genotype is useful in prediction of sertraline blood level.

NCT ID: NCT05210140 Recruiting - Clinical trials for Depressive Disorder, Major

Personalized Escitalopram Dosing in Patients With Depression

PsyCise-E
Start date: July 16, 2020
Phase:
Study type: Observational

The aims of this study are to: 1. Determine the proportion of participants who are underdosed or overdosed under recommended dosing regimen of escitalopram for the depression treatment (10 mg/day) 2. Determine and quantify clinical benefits of personalized escitalopram dosing regimen based on the escitalopram blood level monitoring 3. Retrospectively estimate whether the information on CYP2C19 genotype is useful in the prediction of escitalopram blood level.

NCT ID: NCT05205915 Active, not recruiting - Clinical trials for Major Depressive Disorder

Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.

NCT ID: NCT05203341 Completed - Clinical trials for Major Depressive Disorder

Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)

SAVITRI
Start date: February 21, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.

NCT ID: NCT05202119 Completed - Clinical trials for Major Depressive Disorder

Empower: tDCS for Major Depressive Disorder at Home

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

A two-center trial to investigate whether or not active stimulation with the Flow FL-100 tDCS device is superior to sham stimulation for the treatment of major depressive disorder when used at home. Participants perform up to 36 tDCS sessions by themselves without supervision during a blinded 10-week phase, and then 30 more sessions during an unblinded open-label phase.

NCT ID: NCT05195203 Completed - Clinical trials for Major Depressive Disorder

A Study of HS-10353 in Chinese Participants.

Start date: January 27, 2021
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10353 separately in Chinese healthy and major depressive disorder subjects.