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The primary objective of this multicenter, randomized, sham-controlled, double blind (patient and observer blinded) clinical trial is to assess the antidepressant effect of Deep Brain Stimulation (DBS) in patients with treatment resistant major depression using the Boston Scientific implantable Vercise™ GEVIA™ DBS system compared to sham.
Randomized, two-part, placebo-controlled study of single ascending doses of NV-5138 in healthy volunteers, and a single dose of NV-5138 in subjects with Treatment-Resistant Depression (TRD)
This is a feasibility study and the goal of this project is to evaluate whether ACC glutamine, quantified as a CSF-corrected absolute concentration percent change from baseline, is associated with clinical remission, Montgomery Asberg Depression Rating Scale (MADRS) total score of =9, to the anti-glutamatergic antidepressant ketamine. As MRS is expensive, we also aim to study a correlation between peripheral glutamate and central glutamate level.
The investigators will conduct a randomized controlled trial (RCT), comparing SSM (n=96) versus HEP (n=96) in 192 LLD participants stratified by site and presence of treatment resistant late life depression (TR-LLD). Participants will be blinded to the treatment hypothesis while investigators, raters and treating clinicians will be additionally blinded to the intervention. Both SSM and HEP will be taught over 4 consecutive days in similar sized groups (4-10 participants) followed by weekly reinforcement sessions for subsequent 11 weeks. Trained raters will collect data on depression symptoms (HAM-D 17 scale) and cognition at baseline, 12-week and 26-week follow-up as the primary and secondary outcome measures respectively.
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.
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.
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.
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
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.
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.