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Depression, Bipolar clinical trials

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NCT ID: NCT06105762 Not yet recruiting - Clinical trials for Major Depressive Disorder

Ketogenic Diet for Depression

KETO-MOOD
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Globally, it's estimated that around 300 million people are affected by depressive illness, and even with access to modern mental health care, long-term recovery is uncommon. Recently, there has been increasing interest in a promising intervention: the ketogenic diet. This diet restricts carbohydrate intake, promoting the breakdown of fats into circulating ketone bodies, which can act as an additional energy source for the brain, potentially reducing its reliance on glucose. While various sources of evidence suggest the potential benefits of the ketogenic diet for individuals with depression, robust clinical studies on its efficacy in depressed patients are lacking. Our goal is to conduct an eight-week, assessor-blinded, randomized controlled trial to investigate the therapeutic effects of a very low-carbohydrate, high-fat ketogenic diet compared to an active comparator diet in individuals with depression.

NCT ID: NCT05958940 Not yet recruiting - Clinical trials for Depression, Unipolar

BioClock: Bright Light Therapy for Depressive Disorders

Start date: September 2023
Phase: N/A
Study type: Interventional

Bright Light Therapy (BLT) is a proven treatment for depression in seasonal and non-seasonal depressive disorders, as well as bipolar disorder. To make BLT more effective and practical in clinical settings and tailor it to individual needs, it is necessary to optimize the treatment approach, understand how the treatment works, and identify patient characteristics that predict response. This clinical trial has three main goals: - Optimize the administration of BLT for patients with depressive episodes. - Gain a deeper understanding of the treatment mechanisms. - Determine which patients benefit the most from the treatment. The specific objectives are as follows: - Investigate whether additional treatments and interventions related to lifestyle and the biological clock can enhance the effects of BLT. - Examine how BLT influences the body's internal clock and sleep quality, and how these factors contribute to the outcomes. - Identify patient characteristics and behaviours that can predict treatment outcomes. - Develop a brain model to better understand the impact of BLT on the brain. In this study, patients will receive BLT with a light intensity of 10,000 lux for 30 minutes each morning over 5 consecutive days. The treatment duration will range from one to three weeks, depending on the improvement of depressive symptoms. Participants will be randomly assigned to one of three groups: - Home - Patients will receive BLT at home, following the standard guidelines for light therapy in the Netherlands. - LightCafé, fixed time: Patients will receive BLT in a café-like setting called the LightCafé, where the focus is not only on symptom improvement but also lifestyle enhancements and fostering social connections. The treatment time will be the same every day. - LightCafé, varying time: Patients will also receive BLT at the LightCafé, with treatment timing varying each day. Additionally, this group will wear glasses in the evening that filter blue light. The study includes a baseline phase of up to two weeks, a treatment phase of up to three weeks, and a three-month follow-up phase. Patients will wear a motion watch to assess sleep-wake behaviour and physical activity during the day. Additionally, they will wear a broach that measures their personal light exposure throughout the day. Eight one-minute questionnaires per day will be sent to the participants' smartphones to assess vitality, sleep, and mood during the treatment. Predictors of treatment response, such as clinical characteristics, sleep measures, circadian parameters, and light-related behaviours, will be evaluated at baseline. In a small group of patients, salivary melatonin curves will be assessed before and after treatment. MRI scans will provide insights into functional and structural brain changes following light therapy treatment.

NCT ID: NCT05568823 Not yet recruiting - Clinical trials for Major Depressive Disorder

Biomarkers of ANTidepressant RESponse and Development Risk of Bipolar Disorder

ANTaRES
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

One in five people will present a major depressive episode (MDE) in their lifetime. While antidepressants (ADs) are currently the standard treatment for MDE, the first AD prescribed is effective in less than 40% of patients and a complete clinical response is only observed after several weeks. Identifying early biomarkers of the response to treatment with an AD could allow the clinician to rapidly identify patients in whom treatment will not be effective and therefore modify patient care. We have recently shown that the messenger RNA (mRNA) of two proteins, ELK1 and GPR56, were present in different amounts in the blood cells of "responder" compared to those of "non-respondent" patients. In this context, our main objective will be to determine whether ELK1 and GPR56 mRNAs, are very early biomarkers of the response to AD, i.e., biomarkers whose variation precedes the clinical response by several weeks. Secondary objectives will be to identify early phase changes in neurophysiological measures, cognitive and behavioral tasks, as well as levels of blood coding and non-coding RNAs, serum cytokine, mitochondrial and metabolic markers, neuroimaging markers as biomarkers of differential treatment outcomes to antidepressant treatment. Patients will be treated with SERTRALINE or FLUOXETINE or DULOXETINE or MAPROTILINE (in monotherapy) with or without adjunct benzodiazepine. Patients are identified as responders or non-responders based on their clinical assessment at 8 weeks after treatment onset. In addition, a second stage will collect data to address another important issue for the management of patients with a MDE: to discriminate those with a major depressive disorder (MDD) from those with a bipolar disorder (BD). BD diagnosis is one of the most common reasons of failure to response to ADs. Therefore, one of our secondary objectives will be to identify biomarkers to differentiate between these two categories of patients. To do this, we will follow patients for a period of 24 months to identify those who will present during this follow-up the diagnostic criteria of bipolarity.

NCT ID: NCT04399070 Not yet recruiting - Clinical trials for Major Depressive Disorder

The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)

ECT
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

This study will determine the effectiveness and safety of S-Ketamine in depression patients undergoing electroconvulsive therapy.