Clinical Research Directory

EEG Microstate and Neuroinflammatory Biomarkers in Older Age Patients With Major Depressive Disorder Receiving ECT

This study aims to investigate the neurophysiological and inflammatory changes associated with electroconvulsive therapy (ECT) in older age patients diagnosed with Major Depressive Episode, Major Depression, and Bipolar Disorder, using microstate analysis derived from resting-state electroencephalography (EEG) recordings. Within this scope, EEG recordings obtained before and after ECT will be compared to determine the relationships between changes in microstate parameters and inflammatory marker levels, clinical variables, and psychometric scale scores reflecting clinical improvement. Peripheral blood samples collected from the same patient group will be analyzed for complete blood count parameters as well as levels of interleukin-1 alpha (IL-1α), interleukin-1 beta (IL-1β), interleukin-2 (IL-2), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-α), soluble glycoprotein 130 (sgp-130), soluble interleukin-6 receptor (sIL-6R), interferon gamma-induced protein 10 kDa (IP-10), and C-reactive protein (CRP). In addition, inflammatory indices, including the Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), and Monocyte-to-Lymphocyte Ratio (MLR), will be calculated. The association between baseline levels of these biomarkers and treatment response will be evaluated. Moreover, changes in biomarker levels following ECT will be statistically examined in relation to clinical scale scores and EEG microstate parameters. Although microstate analysis and inflammatory biomarkers have each been extensively investigated in psychiatric disorders, studies evaluating these two biomarkers together, particularly with the inclusion of healthy control participants, in the older age population remain limited. In this regard, the present study aims to evaluate the effects of ECT on older age patients using objective neurophysiological indicators, contribute to the understanding of the pathophysiology of depression at the level of brain networks, and provide a scientific basis for the development of personalised treatment approaches in the future.

Shortened LSD Intervention for Major Depressive Disorder

The purpose of this study is to determine the safety and clinical effectiveness of a shortened lysergic acid diethylamide (LSD) experience. This will be achieved by administering the drug risperidone 45-minutes after the administration of LSD.

Oral and Sublingual Ketamine

Major Depressive Disorder (MDD) is one of the most common and severe mental illnesses in the world. Ketamine treatment, especially intravenous ketamine (IVK) and intranasal esketamine (INE), is becoming more popular and is being used more. But these ways of administering aren't perfect. They mostly have problems with cost, accessibility, and the issues of administering. The oral and sublingual routes of ketamine are cheaper alternatives, but they haven't been looked into as much in the medical and academic circles. This is a small pilot feasibility study, involving ten patient participants who will be randomly assigned to take ketamine by oral and sublingual routes as part of a single-blind, crossover design. A local London pharmacy-Ultimate Care Compounding will provide the ketamine formulations. Ten patients between 18 and 65 years old with Major Depressive Disorder will be recruited from the Mental Health Care Programs at LHSC, Victoria Hospital and SJHC, Parkwood Institute, (that has treatment resistant depression treatment focus). After a screening baseline visit, which will include clinical interviews with medication reconciliation, psychiatric evaluations, routine standard laboratory tests, and an electrocardiogram (ECG). Due to capacity limitations at the Centre for Clinical Investigation and Therapeutics (CCIT), a maximum of 5 participants will undergo pharmacokinetic sampling simultaneously, enrolment will proceed in two sequential groups with treatment order assigned by group. Group A (n=5): The first 5 eligible participants will receive oral ketamine in Treatment Period 1 and sublingual ketamine in Treatment Period 2. Group B (n=5): The next 5 eligible participants will receive sublingual ketamine in Treatment Period 1 and oral ketamine in Treatment Period 2. Recruitment for Group B will commence once Group A has completed the clinical intervention phase. During Monday and Thursday of each of Weeks 1 and 2, Group A will receive oral ketamine, while Group B will receive sublingual ketamine. Weeks 3 and 4 are a washout period. In Weeks 5 and 6, on Mondays and Thursdays, groups will switch to the other form of administration \[See flowchart of study procedure\]. Weeks 7 and 8 are washout periods to ensure consistency with the first half of the study and provide a similar framework for clinical assessments. Blood samples will be collected at 2 time points at the Center for Clinical Investigation and Therapeutics at University Hospital. The study goal is to help define safe and effective oral/SL ketamine doses based on Pharmacokinetic profiles.

Virtual Reality-Augmented At-Home tDCS for Major Depression

The goal of this clinical trial is to investigate the efficacy of combining Virtual Reality (VR)-based relaxation and Transcranial Direct Current Stimulation (tDCS) for treating Major Depression. The main questions this study aims to answer are: 1. Does the combination of VR Relaxation and tDCS at-home result in significantly greater symptom improvement in depression than tDCS alone? 2. Are there differences in treatment effectiveness depending on demographic characteristics (e.g., age, gender)? 3. Feasibility: What is the level of acceptance and adherence to the combined VR and tDCS therapy compared to tDCS alone? In a randomized controlled trial, patients will be assigned to either a tDCS + VR group or a tDCS-only group. The study protocol is the following: * On the first day, patients complete baseline questionnaires and are then randomly assigned to either the tDCS-only group or the tDCS + VR group. * Both groups perform home-based treatment five times per week for four weeks, with each session lasting 30 minutes. * After two weeks, patients return for a follow-up visit to complete questionnaires and assess adherence, side effects, and clinical progress. * At the end of the four-week treatment period, a final assessment is conducted, including questionnaires and patient feedback. * After 12-16 weeks (i.e. 2 to 3 months after the last tDCS session) Follow Up Assessment (BDI, MADRS, HDRS, GCI, GAF)

Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling

The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.