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Treatment Resistant Depression clinical trials

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NCT ID: NCT03360942 Active, not recruiting - Clinical trials for Treatment Resistant Depression

Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression

Start date: April 18, 2016
Phase: N/A
Study type: Observational

The long term follow up of a pilot study in which the invesitagors proposed to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the effects of left-sided vs. right-sided stimulation, and to investigate potential mechanisms of action of this intervention. Importantly, this study will be used to assess the need for and assist in planning a larger, more definitive trial of SCC DBS for TRD.

NCT ID: NCT03329391 Not yet recruiting - Clinical trials for Treatment-resistant Depression

Psychosocial Characteristics and Non-pharmacological Intervention of Patients With Treatment-resistant Depression

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Pharmacotherapy and psychotherapy, effective management strategies for treatment-resistant depression are limited and yet to be developed. However, nursing interventions focusing on adherence enhancement, symptom reduction, and stress management may be strategic for a better disease management. This study aims to define the rarely-studied concept of TRD under the cultural context of Taiwan and to identify new feasible treatment model from nursing perspectives. The project will establish important basis on the descriptions of psychosocial features and need assessment of people with TRD under experienced psychiatric team validation, and also build up a cultural-specific non-pharmacological intervention module for effective TRD management in Taiwan. The nursing model of TRD management will promote the development of integrative depression care in the future and complement current modalities, while providing important evidence-based information for further research and services.

NCT ID: NCT03320304 Not yet recruiting - Clinical trials for Treatment Resistant Depression

A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.

RESTORE-LIFE
Start date: December 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy.

NCT ID: NCT03312894 Not yet recruiting - Clinical trials for Treatment-Resistant Depression

Efficacy and Safety of TAK-653 in Treatment-Resistant Depression

Start date: November 15, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of TAK-653 compared with placebo in maintaining the effect of ketamine treatment on depressive symptoms.

NCT ID: NCT03290963 Enrolling by invitation - Clinical trials for Treatment Resistant Depression

Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine

Start date: March 2018
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to compare the antidepressant effect of lithium versus placebo in adults receiving ketamine. Lithium is available commercially for depression; ketamine is available commercially and can help the symptoms of depression; however, it has not been approved by the U.S. Food and Drug Administration (FDA) for this use. The FDA has allowed the use of this drug in this research study.

NCT ID: NCT03288675 Recruiting - Clinical trials for Depressive Disorder, Major

Stepped Care aiTBS 2 Depression Study (Ghent)

aiTBS2-Ghent
Start date: October 5, 2017
Phase: N/A
Study type: Interventional

Antidepressant-free unipolar melancholic depressed patients (at least stage 2 treatment-resistant) will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews. Because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. Only habitual benzodiazepine agents will be allowed. STEP 1: Patients will be treated with in total 20 accelerated intermittent Theta Burst Stimulation (aiTBS) sessions (3000 pulses/session) over the left dorsolateral prefrontal cortex, which will be spread over 4 days. On each stimulation day, a given patient will receive 5 sessions with a between-session delay of 15 minutes. Patients will be randomized to receive either the real aiTBS or sham treatment (first week). However, the sham group will receive real aiTBS treatment with 10 days' time interval. The investigators expect that real aiTBS treatment and not sham will result in a significant and clinical meaningful response. STEP 2: To optimize treatment and reduce relapse following the iTBS treatment, in a stepped care approach, all patients then continue with cognitive control training (CCT) ten days later. This CCT consists of 20 sessions, spread over 4 weeks. Patients will be randomized to receive either real CCT or a control training. During this follow-up treatment, all patients will be prescribed antidepressant medication (SSRI) again. As iTBS treatment effects are known to decline over time, the investigators expect that combining aiTBS with a follow-up CCT therapy will stabilize the clinical effects over time compared to receiving the iTBS treatment alone. For baseline comparisons, patients will be closely matched for gender and age with never-depressed, medication-free healthy volunteers. No volunteer will undergo treatment.

NCT ID: NCT03272698 Recruiting - Clinical trials for Treatment Resistant Depression

ECT With Ketamine Anesthesia vs High Intensity Ketamine With ECT Rescue for Treatment-Resistant Depression

Start date: September 1, 2017
Phase: Phase 4
Study type: Interventional

To determine if an high intensity ketamine with ECT rescue (HIKER) approach for treatment resistant depression will: 1) reduce patient suffering by hastening disease remission, 2) have fewer side effects, 3) reduce the need for ECT, and 4) be preferred by most patients. Half of participants will be randomized to the HIKER arm and receive high intensity ketamine treatment for eight consecutive days, and the other half will be assigned to the ECT with ketamine anesthesia (EAST) arm and receive 8 ECT treatments (2-3 treatment/week)

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

TBS in Major Depression

Start date: August 1, 2017
Phase: Phase 4
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: NCT03240692 Enrolling by invitation - Clinical trials for Treatment Resistant Depression

Accelerated Theta Burst Stimulation in Treatment-Resistant Depression

aTBS
Start date: May 1, 2017
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 depression. In this open label study, all participants will receive accelerated theta-burst stimulation.

NCT ID: NCT03175887 Not yet recruiting - Depression Clinical Trials

Investigational TMS Treatment for Depression

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

This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression.