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Depressive Disorder, Treatment-Resistant clinical trials

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NCT ID: NCT03953417 Not yet recruiting - Clinical trials for Treatment Resistant Depression

Bilateral Accelerated Theta Burst in Treatment-Resistant Bipolar Depression

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant bipolar depression. In this open-label study, all participants will receive accelerated theta-burst stimulation.

NCT ID: NCT03952962 Not yet recruiting - Clinical trials for Treatment Resistant Depression

Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

Start date: July 2019
Phase: N/A
Study type: Interventional

Treatment resistant depression remains a major problem for individuals and society. Surgical procedures may provide relief for some of these patients. The most frequently considered surgical approach is deep brain stimulation (DBS) of a part of the brain called the subcallosal cingulate region. However, the effectiveness and safety is not well established. The investigators will use a novel approach using advanced imaging technique (magnetic resonance tractography) to evaluate the feasibility and safety of this surgical approach. An innovative method for the definition of DBS target will be applied that redefines the concept of targeting as one of targeting a symptomatic network rather than a structural brain region using subject-based brain anatomy to define the target location. The correlation between imaging findings at baseline with the mood score changes at different time points of the study will be investigated.

NCT ID: NCT03947827 Not yet recruiting - Clinical trials for Treatment Resistant Depression

Minocycline as Adjunctive Treatment for Treatment Resistant Depression

MINDEP2
Start date: August 2019
Phase: Phase 3
Study type: Interventional

Major depressive disorder (MDD) is a leading cause of disability worldwide. Up to 50% of patients experience treatment resistant depression (TRD), which accounts for a vast majority of disease burden. Current medications for TRD have limited efficacy and can be associated with intolerable side effects. Therefore, there is a need for finding new treatment targets. Accumulating evidence suggests some patients with MDD including those with TRD, display brain inflammation. Thus, patients with TRD may benefit from medications that can reduce this inflammation. Minocycline is an antibiotic which can cross the blood-brain barrier and has effects on several systems implicated in depression. The principal investigator led the first pilot study of minocycline as an add-on treatment in TRD demonstrating that it led to a significant reduction in depressive symptoms compared to placebo and these findings require replication in a larger sample to confirm the efficacy and tolerability of this treatment approach. This study is a 12 week, double-blind, placebo-controlled trial of minocycline as add-on treatment for patients suffering from a major depressive episode who have failed to respond to at least two adequate trials of antidepressant treatment. After screening and randomization to the two parallel arms of the trial, 50 patients will receive minocycline added to treatment as usual (TAU) and 50 patients will receive placebo added to TAU. Clinical assessment will include the Hamilton Depression Rating Scale (HAMD-17), Clinical Global Impression scale (CGI), Patient Health Questionnaire (PHQ-9), and the Generalized Anxiety Disorder scale (GAD-7) at each study visit (screening, baseline, week 2, 6, and 12). Side effects checklists will be undertaken at each visit. Minocycline will be started at 100 mg once daily and will be increased to 100 mg twice daily at two weeks. Secondary outcomes include inflammatory biomarkers measured at baseline, weeks 6 and 12. This trial will provide further evidence of minocycline's efficacy and acceptability as a treatment option for patients with TRD and provide insights into its mechanism of action.

NCT ID: NCT03932825 Recruiting - Depression Clinical Trials

Nitrous Oxide for Major Depressive Disorder

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

This study aims at investigating the persistence of antidepressant effect of Nitrous Oxide (N2O) for Treatment-Resistant Depression(TRD). The investigators also aim to assess the effect of N2O on the electroencephalograph, multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in patients with TRD. The investigators further aim to identify the predictors of N2O's antidepressant effeect using the above techniques.

NCT ID: NCT03923361 Recruiting - Clinical trials for Treatment Resistant Depression

Neural and Antidepressant Effects of Propofol (Phase 2)

Start date: April 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.

NCT ID: NCT03887715 Not yet recruiting - Clinical trials for Treatment Resistant Depression

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

RECOVER
Start date: July 31, 2019
Phase: N/A
Study type: Interventional

Objectives of this study are to determine whether active VNS Therapy treatment is superior to a no stimulation control in producing a reduction in baseline depressive symptom severity, based on multiple depression scale assessment tools at 12 months from randomization.

NCT ID: NCT03887624 Not yet recruiting - Clinical trials for Depressive Disorder, Treatment-Resistant

Investigate the Clinical Responses of Ethosuximide in Patients With Treatment-Resistant Depression.

Start date: April 15, 2019
Phase: Early Phase 1
Study type: Interventional

This study evaluates the efficacy and safety of ethosuximide in the treatment of refractory depressive disorder in adults. Half of participants will receive ethosuximide and escitalopram in combination, while the other half will receive a placebo and escitalopram.

NCT ID: NCT03852160 Not yet recruiting - Clinical trials for Depressive Disorder, Treatment-Resistant

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Start date: May 22, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of treating participants with treatment-resistant depression (TRD) who have failed at least 2 (and no more than 6) prior antidepressant (AD) treatments in the current moderate to severe depressive episode with flexibly-dosed esketamine nasal spray plus a newly initiated oral standard-of-care AD compared with placebo nasal spray plus a newly-initiated standard-of-care oral AD, in achieving remission and staying relapse-free after remission.

NCT ID: NCT03851380 Not yet recruiting - Depression Clinical Trials

Improving Brain Stimulation Through Imaging

IBSI
Start date: May 1, 2019
Phase:
Study type: Observational

Repetitive pulse transcranial magnetic stimulation (rTMS) is a noninvasive treatment that involves stimulating the brain; however, treatment benefit depends on placing a TMS coil in the correct place on the head to reach critical brain regions below. Clinicians typically use scalp-based targeting, a process in which rather than using MRI guidance to target brain regions for stimulation, they use landmarks on the scalp. Several researchers, including the investigators' lab, showed that the current scalp-based targeting techniques do not position stimulation above the correct brain region, and patients fail to respond. The investigators propose to improve clinical scalp-based targeting by comparing it to MRI guided targeting. The most common clinical population receiving rTMS therapy is depressed patients. The investigators' plan is to study the accuracy of certain scalp-based rules in patients with depression. Accurate brain stimulation targeting is critical for effective rTMS therapy.

NCT ID: NCT03833063 Not yet recruiting - Clinical trials for Major Depressive Disorder

Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression

BOTDEP
Start date: March 1, 2019
Phase: Phase 1
Study type: Interventional

The effectiveness of glabellar injection of botulinum toxin type A (BTA) in treating depression has not yet been investigated in elderly patients. The study aims in addressing the question if glabellar injection of BTA is effective in treating geriatric depression.