View clinical trials related to Depressive Disorder, Major.
Filter by:Randomized, multi-site, sham-controlled, double-blinded study
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....
Major depressive disorder has a prevalence of 4.7% in the general population and is ranked as the leading cause of disability worldwide. The efficacy of current antidepressants is limited, as 50-60% of patients do not achieve a sufficient response to treatment : 12% achieve only a partial response, while 19-34% do not respond at all. These uncertain clinical effects are only observed after several weeks of treatment. For better patient management, there is an urgent need to identify markers for predicting and monitoring therapeutic response. Psychiatrists at the Nancy Psychotherapeutic Center are about to launch a "MESANTIDEP" study, in which they will evaluate the electroretinogram (ERG) as a biomarker for predicting and monitoring therapeutic response. The TEPDEP study described in this protocol would evaluate 18F-FDG brain PET/CT as a biomarker for predicting antidepressant response in a treatment-naive patient population. It is planned to offer the PET/CT study to patients included in the SSRI arm of the MesantiDEP study. The hypothesis of this study is that 18F-FDG PET/CT could be a biomarker for predicting response to selective serotonin reuptake inhibitor (SSRI) antidepressants.
The goal of this clinical trial is to study how physical exercise works when applied to patients diagnosed with Major Depressive Disorder (MDD). The main questions it aims to answer are: - What are the antiinflammatory and oxidative stress and neural mechanisms involved in the antidepressant effects of exercise? - How effective is a physical exercise program in MDD patients in real-life conditions? The experimental group will receive an exercise intervention as an add-on to their usual treatment (antidepressant treatment prescribed by the attending specialist). Researchers will compare to a control group, which will only receive standard treatment (antidepressant treatment prescribed by the attending specialist) and will be instructed to not change their usual physical activity. The aim is to see if a physical exercise intervention would induce a significant improvement in depressive symptoms and which mechanisms are responsible for this result.
The goal of this randomized controlled trial is to assess the efficacy and safety of low-dose laser acupuncture (LLA) in alleviating insomnia symptoms among patients suffering from major depressive disorder. The study seeks to answer the following questions: 1. How effective is LLA in alleviating insomnia symptoms as compare with SLA and control subjects among patients with major depressive disorder across pre-treatment, mid-treatment and post-treatment assessment? 2. What role do CORT and 5-HT play in the co-occurrence and progression of insomnia and major depressive disorder, and how does LLA act on these mechanisms to provide relief? 3. Does LLA enhance the effectiveness of pharmacological interventions in treating insomnia and major depressive disorder when used as an adjunctive treatment? 4. How does the safety and acceptability of LLA compare to traditional acupuncture in terms of eliminating discomfort and potential side effects? Researchers will compare the effects of LLA with sham laser acupuncture (SLA) and standard medication treatments to evaluate its efficacy and safety. Participants involved in this study will: Undergo 30 treatment sessions with LLA or SLA, five times a week for six weeks. Continue their usual pharmacological treatments for major depressive disorder. Participants will undergo comprehensive assessments at key points: pre-treatment, immediately post-treatment, and 12 weeks post-treatment. These evaluations will measure sleep quality indices, levels of depression and anxiety, and blood levels of CORT and 5-HT to assess the impact of LLA on insomnia symptoms and biochemical markers. Additionally, participant acceptance and the safety of the treatment will be monitored, including recording any adverse events and medication usage, to determine the effectiveness and safety of LLA in treating insomnia associated with major depressive disorder. By focusing on these elements, the study aims to provide clear, actionable insights into the benefits and risks of LLA as a treatment option for insomnia associated with major depressive disorder, enhancing the current treatment landscape and patient outcomes.
Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.
The present study aims to develop a culturally and methodologically adapted EMDR therapy protocol, determine its treatment fidelity, and then clinically test its efficacy in the treatment of Major Depressive Disorder in Pakistan by utilizing both in-person and online modalities of EMDR therapy.
This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression.
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000, in participants with Major Depressive Disorder (MDD).
To enroll in this clinical trial, prospective participants must meet stringent criteria. The participants need to fall within the age range of 18 to 64 and exhibit chronic depression at therapy resistance stage 2. This stage signifies that the participants have undergone unsuccessful treatment with at least two different antidepressants, despite adequate dosage and duration. Moreover, the participants should have engaged in at least 12 sessions of psychotherapy without experiencing significant relief from depressive symptoms. Additionally, participants must demonstrate the cognitive capacity to provide informed consent. Upon expressing interest in the study and consenting to participate, individuals undergo a thorough screening process. This screening encompasses a comprehensive clinical interview to assess medical and psychiatric history, as well as various medical tests. These tests include physical examinations, blood draws (which may include pregnancy tests for female participants), and electrocardiograms (ECGs) to evaluate heart function. Following the screening, participants are randomly assigned to one of three different treatment groups (Ketamine +TAU; Ketamine+CBASP, Placebo+CBASP). The study protocol involves a combination of psychotherapeutic treatment and either ketamine infusions or placebo. Throughout the study period, participants are subject to regular data collection, including psychological assessments, blood samples, and magnetic resonance imaging (MRI) scans. Participants' responses to treatment, as well as any changes in symptoms or side effects, are closely monitored. After completing the study, participants are offered follow-up therapy as part of standard care. MRI scans are conducted to examine changes in brain activity associated with treatment response and depressive symptomatology, particularly focusing on alterations in neural circuitry and thought processes. Additionally, participants are encouraged to report any changes in medication regimen or other treatments received during the study period.