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Treatment Resistant Depression clinical trials

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NCT ID: NCT03537794 Not yet recruiting - Clinical trials for Treatment Resistant Depression

Characterizing Dopamine Receptor Binding in Treatment Resistant Depression

Start date: June 2018
Phase:
Study type: Observational

It is estimated that 30% of individuals with Major Depressive Disorder (MDD) fail to respond to conventional antidepressant medication which accounts for over 1 million Canadians in their lifetime. Treatment resistant depression (TRD) patients also have greater psychiatric and medical comorbidity, poorer quality of life and increased suicidal ideation. Yet, there are few treatment strategies available to target TRD and there is a significant lack of evidence about how TRD differs from treatment-responsive depression. This proposal represents the first study to elucidate the neurobiology of TRD with a focus on dopamine receptor function throughout the brain, in order to inform treatment development and clinical characterization of TRD.The ultimate goal of this unique study is to characterize striatal and extrastriatal dopamine D2 and D3 receptor binding potential in patients with TRD, non-resistant MDD and healthy controls. The primary hypothesis is that TRD patients will exhibit greater D2/D3 receptor binding potential compared to non-TRD patients in the following regions of interest: dorsolateral prefrontal cortex, orbitofrontal cortex, and ventral striatum. Secondarily, non-TRD patients will also demonstrate increased binding potential compared to healthy controls in the same brain regions. Whole brain analyses will allow us to take an exploratory approach to other brain regions that may differentiate TRD from non-TRD patients. Participants will be assessed at St. Michael's Hospital (SMH) and the Centre for Addiction and Mental Health (CAMH), which are within a 10 minute driving distance of each other. There will be 3 study visits following written informed consent. Eligibility will be confirmed at a screening visit at SMH where demographic information, including age, sex, education, and medication history will be obtained, as well as the administration of a structured Mini-International Neuropsychiatric Interview (MINI) for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Axis I diagnoses (Sheehan et al, 2015), and an HRSD-17. Within two weeks of the screening visit, participants will undergo a structural magnetic resonance imaging (MRI) scan at SMH prior to the positron-emission tomography (PET) scan at CAMH. The order of the PHNO scans will be counterbalanced.

NCT ID: NCT03515733 Not yet recruiting - Clinical trials for Treatment Resistant Depression

PF-04995274 and Emotional Processing in Treatment Resistant Depression

RESTART
Start date: May 2018
Phase: Phase 1
Study type: Interventional

This study will test whether seven days adjunctive administration of a serotonin receptor subtype 4 (5HT4) agonist called PF-04995274 has positive effects on emotional processing and neural activity in medicated, treatment-resistant depressed patients compared to placebo.

NCT ID: NCT03435744 Not yet recruiting - Clinical trials for Major Depressive Disorder

Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.

DepSTAT
Start date: April 1, 2018
Phase: Phase 3
Study type: Interventional

In this double blind, randomized placebo controlled trial we aim to determine the efficacy of simvastatin as an add-on treatment for treatment resistant depression. We will recruit 150 people with treatment-resistant depression with the aim of determining whether the addition of simvastatin (20mg daily) to treatment as usual (TAU) for 12 weeks leads to an improvement in depressive symptom compared with placebo added to TAU.

NCT ID: NCT03428828 Not yet recruiting - Clinical trials for Treatment Resistant Depression

Neurofeedback for Treatment Resistant Depression

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

The purpose of this study is to determine the clinical efficacy of real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories in patients with depression who are considered treatment-resistant

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 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 14, 2017
Phase:
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 Withdrawn - Clinical trials for Treatment-Resistant Depression

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

Start date: February 15, 2018
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.