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Depressive Disorder, Major clinical trials

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NCT ID: NCT03283670 Completed - Clinical trials for Depressive Disorder, Major

Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies

NARSAD
Start date: November 22, 2016
Phase: Phase 2
Study type: Interventional

The purpose of the study aims to determine whether different concentrations of nitrous oxide (N2O) have different antidepressant effects for adults with treatment-resistant major depression.

NCT ID: NCT03281044 Terminated - Clinical trials for Major Depressive Disorder

Fecal Microbiota Transplantation in Depression

Start date: October 24, 2018
Phase: Phase 2
Study type: Interventional

The prevalence of psychiatric disorders such as major depression disorder (MDD) is increasing rapidly. Despite advancements in the development of therapeutics, current treatment options have not reached optimal efficacy. Recent interest has been drawn towards the importance of the biochemical signalling between the gastrointestinal tract and the central nervous system also known as the "microbiome-gut-brain axis". The pathogenesis of gut microbiota in extra intestinal diseases was inspired by massive studies in germ free (GF) animals, which indicated that the gut microbiota plays a role in the normal regulation of behaviour that are relevant to mood, anxiety and stress. However, the exact mechanisms by which intestinal dysbiosis are involved in the development of psychiatric diseases are not completely clarified. A new method to alter the composition of the gastrointestinal microbiota involves fecal microbiota transplantation (FMT). The goal of FMT is to introduce or restore a stable microbial community in the gut by transplanting intestinal microbiota from a healthy donor to the patient. FMT, as a microbiota-target therapy, is arguably very effective for curing recurrent Clostridium difficile infection and has good outcomes in other intestinal diseases. At the same time, applications in previously unexpected areas, including metabolic diseases, neuropsychiatric disorders, autoimmune diseases, allergic disorders, and tumors have shown health enhancing results. FMT has initially been conducted using colonoscopy. However, recent evidence has shown that treatment with frozen FMT capsules (to be taken orally) is also safe and beneficial in restoring the gut microbiota in patients with various diseases As FMT capsules may be an effective, pragmatical adjuvant therapy (in addition to standard treatment) for depression, this project is aimed at (1) investigating for the first time if single administration of FMT capsules ameliorates depressive symptoms in patients with moderate to severe MDD 4 weeks after treatment and (2) establishing the safety profile of encapsulated FMT in MDD. Furthermore, we will also test if (3) FMT capsules modulates immune signalling and inflammatory processes, (4) Hypothalamic-pituitary-adrenal (HPA) axis responses, (5) neurogenesis, (6) energy balance hormones, (7) gut microbiota composition and (8) brain perfusion, structure and activation.

NCT ID: NCT03275961 Completed - Depression Clinical Trials

Stress Management and Resiliency Training (SMART) Integrated Into Treatment of Major Depression

Start date: November 29, 2016
Phase: N/A
Study type: Interventional

The investigators are doing this research study to find out if the Stress Management and Resiliency Training (SMART) therapy will help subjects with their major depression treatment.

NCT ID: NCT03275766 Completed - Clinical trials for Major Depressive Disorder

Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders

Start date: June 1, 2016
Phase: N/A
Study type: Interventional

Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of repetitive transcranial magnetic stimulation (rTMS) may ameliorate psychomotor slowing in schizophrenia or major depression.

NCT ID: NCT03265808 Recruiting - Clinical trials for Major Depressive Disorder

Allogeneic Human Mesenchymal Stem Cell Infusion vs Placebo in Alcohol Use Disorder and Major Depression.

Alaunus
Start date: March 18, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to look at the safety of a study treatment with stem cells in Alcohol Use Disorder And Major Depression (AUD-MD) subjects.

NCT ID: NCT03265340 Completed - Clinical trials for MAjor Depressive Disorder

Clinical Effect of dTMS in Major Depressive Disorder

Start date: September 2014
Phase: N/A
Study type: Interventional

Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS) dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate to severe MDD without concurrent medication will be randomised to three different treatment protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.

NCT ID: NCT03257397 Recruiting - Clinical trials for Treatment Resistant Depression

TBS in Major Depression

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Background Major depression is associated with morbidity and increased mortality. Along with the psychological strain depression represents a high socioeconomic burden costing Europe more than €113 billion/year. About one third of patients do not respond to appropriate therapy. Theta-burst stimulation (TBS), a form of transcranial magnetic stimulation is an emerging treatment for patients for whom pharmacological treatment is ineffective or not appropriate. Based on two different theories of prefrontal dysfunction two TBS-protocols should have the most antidepressant effects. However, no study so far has compared the two approaches or systematically investigated their differential effects on brain function and on a symptom level. Objectives of the study The aim of this study is to test two TBS protocols on symptom improvement and associated brain function in patients with treatment resistant depression (TRD): iTBS over bilateral DLPFC and iTBS over left and cTBS over right DLPFC. As stimulation over non-motor regions offers no direct readout, fMRI at baseline and after treatment will be harnessed to quantify an effect on brain activity and functional network metrics. Study population 80 patients with TRD will be enrolled with 40 patients receiving the one, and 40 patients receiving the other TBS protocol for a treatment period of three weeks. Study design The study is designed as a longitudinal, randomized and double-blind clinical trial. At baseline and after treatment, patients will undergo psychiatric testing using several symptom scales including the Hamilton Depression Rating Scale (HAMD-17), the Beck Depression Inventory (BDI-II), the Inventory of Depressive Symptomatology (IDS-C) and the State-Trait Anxiety Inventory (STAI). Changes in HAMD-17 scores are defined as primary endpoint. Moreover MRI scans before and after treatment will include structural and functional MRI sequences as well as diffusion weighted imaging (DWI) sequence. Functional connectivity and BOLD responses will serve as primary imaging endpoints. A follow-up visit 2 weeks and a final examination 4 weeks after treatment will elucidate durability of effects. Relevance and implications of the study By investigating which approach is superior for which symptoms our study will contribute to the development of personalized treatment, the reduction of personal suffering and the reduction of costs and occupational disability.

NCT ID: NCT03254342 Terminated - Clinical trials for Major Depressive Disorder

MRS and Medication Response: A Pilot Study

Start date: August 6, 2013
Phase:
Study type: Observational

We hope to demonstrate that magnetic resonance spectroscopy can detect brain concentration levels of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) in depressed patients.

NCT ID: NCT03254017 Terminated - Clinical trials for Treatment Resistant Major Depressive Disorder

Remotely Programmed Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression: An Open Label Pilot Trial

Start date: July 24, 2017
Phase: N/A
Study type: Interventional

The habenula(Hb) is an epithalamic structure located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicates that that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive the changes in midbrain activity linked to depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical case of directly stimulating habeluna for treatment TRD. This research will investigate effectiveness bilateral DBS to habenula for patients with TRD. Programming is a crucial aspect of DBS which directly influences its therapeutic efficacy. Researchers need to ascertain optimum stimulation parameters to help patients achieve optimal control of clinical symptoms. Remote programming of DBS can markedly improve patient convenience, minimize risk of infection and total treatment time and lead to an overall benefit for doctors and patients alike. This research will also investigate safety and benefit of remote programming of DBS.

NCT ID: NCT03242213 Completed - Clinical trials for Major Depressive Disorder

Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement

Start date: July 20, 2017
Phase: N/A
Study type: Interventional

The current randomized controlled trial is a pilot study that will assess the effectiveness and feasibility of a mobile phone application intervention. The objective is to determine whether the use of a mobile health application for patient self-management of depression improves patient-provider engagement for patients diagnosed with major depressive disorder.