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Depression, Bipolar clinical trials

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NCT ID: NCT06462196 Not yet recruiting - Clinical trials for Major Depressive Disorder

Natural History of Depression, Bipolar Disorder and Suicide Risk

Start date: June 26, 2024
Phase:
Study type: Observational

Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation....

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: NCT05913947 Recruiting - Depression, Bipolar Clinical Trials

Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)

DUAG9
Start date: December 13, 2022
Phase: Phase 4
Study type: Interventional

The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease. The main question it aims to answer is: Difference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6) Participants will be randomized to treatment with either lithium or cariprazin. - Will meet for interview and ratings 4 times during study period. - In two meetings, there will be made blood samples and ECG. At one meeting also a Urine sample. - Will be contacted for telephone interviews at 6 occasions.

NCT ID: NCT05767073 Recruiting - Clinical trials for Depression, Unipolar

LIVES: Personalized Lifestyle Intervention for Patients With Depression

LIVES
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Persons with affective disorder have a considerably increased risk of cardiovascular disease. To a considerable extent, this is due to an unhealthy life style. At present, no adequate lifestyle interventions are available for these patients. In the present pilot intervention study we study the acceptability and feasibility of a newly developed lifestyle intervention that is specifically tailored to the needs of patients with affective disorders treated in mental health care or general practice.

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: NCT05436613 Recruiting - Bipolar Disorder Clinical Trials

Transcranial Direct Current Stimulation Therapy for Bipolar Depression

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

Bipolar disorder is a severe and disabling disorder. The course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. The most common treatments are medications. However, for many individuals, combinations of medications are often required, and full recovery is infrequent. The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar depression. The present research question is whether tDCS can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.

NCT ID: NCT05211466 Active, not recruiting - Depression Clinical Trials

Digital Care Chains in Health Care - a Study of Care Consumption, Care Quality, Work Environment and Well-being

Start date: January 17, 2022
Phase:
Study type: Observational

Digital healthcare has developed rapidly to meet demands for accessible healthcare, streamline care and meet future challenges with increasing healthcare needs and reduced labour force in Sweden. Developers and stakeholders in Sweden want to exchange the praxis of phone triage to digital or semi-digital triaging tools, to relieve staff's workload and utilize better resource use that would benefit all patient groups. However, previous studies have showed demographic differences in utilization rate and an increase of simpler care matters when digital healthcare options are offered. Also, little is known of medical accuracy of digital triage tools and of the work environment in digital healthcare. More research is needed on this, as well as on care consumption, care quality and of patients' experiences of digital healthcare. The overall aim of the research project is to study a new digital healthcare platform being introduced in 2021/2022 in the County of Gävleborg, Sweden. The studies will focus on care consumption, healthcare outcomes, care quality and patient safety as well as explore the digital work environment in the digital healthcare platform. Data will be collected before and after the introduction of the digital healthcare platform, using register data and questionnaires. The data from the two time periods will be analyzed with descriptive and inference statistics, to explore if the digital healthcare platform has brought differences on group levels in care consumption, healthcare outcomes, care quality and patient safety as well as in work environment aspects such as the staffs' well-being.

NCT ID: NCT04846010 Recruiting - Depression Clinical Trials

Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2

sequelae
Start date: March 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Post-acute sequelae of SARS-CoV-2 infection can cause multiple system function disorders, and complicated symptoms last for an extended period. The virus can cause this continued infection, or the virus causes immune system function disorder and post-infectious autoimmune disease. The clinical symptoms can be smell loss, taste loss to liver function disorder, kidney function failure, different. No matter how complicated the systems showed in the clinic, all of the symptoms are due to the specific cells being damaged. Our clinical study is focused on recovering the damaged structure and function of the cells that could restore the organ function back to normal or close to normal

NCT ID: NCT04701866 Completed - Clinical trials for Depressive Disorder, Major

Music as an Intervention to Improve Hemodynamic Tolerability of Ketamine in Depression

Start date: January 11, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the impact of music on patients receiving a course of intravenous (IV) ketamine for treatment-resistant depression (TRD), both unipolar and bipolar. The primary outcome is changes in in systolic blood pressure throughout each 40-minute infusion. Secondary outcomes include repeated measures of mood, anxiety, suicidality, and psychological/physical pain. Aspects of the treatment experience, with and without music, will also be explored.