Department of Nutrition, China Medical University
As the investigators know, only few researches focus on the effect of probiotics on depression in hemodialysis patients. Besides, probiotics also have benefit effect on dyslipidemia and hypertension in general population. Both of them are the risk factors of cardiovascular disease which is the major cause of death in hemodialysis patients. Therefore, this study looks for the effect of probiotics on depression syndrome and risk factors of cardiovascular disease in hemodialysis patients. This is a randomized controlled trial. All patients will be assigned at random to intervention group or control group. This study plans to recruit 70 hemodialysis patients and expects at least 30 patients in each group at the end of study period. The investigators provide probiotics (C. butyricum MIYAIRI 588) to intervention group and provide nothing to the control group. All patients need to maintain the lifestyle during study period. Genomic analysis of gut microbiota on patients' fecal samples will be used to evaluation their compliance.
NCT05724511 — Cardiovascular Diseases
Status: Completed
http://inclinicaltrials.com/cardiovascular-diseases/NCT05724511/
Safety and Efficacy of Deep Brain Stimulation for Treatment Resistant Depression
This study will investigate the safety and efficacy of deep brain stimulation (DBS) in lateral habenula (LH) for patients with treatment-resistant depression.
NCT05716555 — Depressive Disorder, Major
Status: Recruiting
http://inclinicaltrials.com/depressive-disorder-major/NCT05716555/
Inhaled Nitrous Oxide for Acute Suicidality and Depression in the Emergency Department
Investigators are conducting this double-blind, randomized control trial (RCT), to compare inhaled N2O+ treatment as usual (TAU) versus inhaled placebo+TAU; demonstrating the feasibility and tolerability of the intervention in an emergency department (ED) setting on an acutely suicidal population.
NCT05710887 — Major Depressive Disorder
Status: Not yet recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT05710887/
Does Psilocybin Require Psychedelic Effects to Treat Depression? A 4-Week, Double-Blind, Proof-of-Concept Randomized Controlled Trial
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of serotonin (5HT)2A receptor antagonists such as risperidone. The purpose of this "double dummy" proof-of-concept trial is to evaluate whether psilocybin's antidepressant effects are dependent on its psychedelic effects. Sixty participants with treatment-resistant depression will be randomly assigned to one of three groups: 1) Psilocybin 25 mg plus risperidone 1 mg; 2) Psilocybin 25 mg plus placebo; and 3) Placebo plus risperidone 1 mg. The investigator's hypothesize that the combination of psilocybin and risperidone will be well tolerated, safe, and will block the psychedelic effects of psilocybin in patients diagnosed with treatment-resistant depression.
NCT05710237 — Treatment-resistant Depression
Status: Recruiting
http://inclinicaltrials.com/treatment-resistant-depression/NCT05710237/
HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2
This randomized two-arm intervention trial administers 8 weekly cognitive behavioral therapy (CBT) sessions and 4 bi-weekly active whole-body hyperthermia (active WBH) sessions or 4 bi-weekly sham WBH sessions to adults aged 18 years or older with major depressive disorder (MDD).
NCT05708976 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05708976/
Confirmatory Efficacy Randomized Clinical Trial of Amygdala Neurofeedback for Major Depressive Disorder
The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as a stand-alone intervention for major depressive disorder
NCT05703256 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT05703256/
The Effect of Logotherapy-Based Intervention on Depression Patients on Depression, Psychological Pain, and Meaning of Life: Follow-Up Study With Control Group
The goal of this interventional study is to compare in logotherapy-based intervention practiced to depressed patients on depression, psychological pain and meaning of life. The main questions it aims to answer are: - Is the logotherapy-based intervention practiced in addition to the standard treatment in depression patients effective in reducing the depression levels of the patients? - Is the logotherapy-based intervention practiced in addition to the standard treatment in depression patients effective in reducing the psychological pain levels of the patients? - Is the logotherapy-based intervention practiced in addition to the standard treatment in depression patients effective in increasing the patients' level of meaning to life? Participants will be done online interview once a week for eight sessions. Researchers will compare intervention and control groups to see if logotherapy-based intervention practiced effect depression, psychological pain and meaning of life levels.
NCT05702736 — Depression
Status: Completed
http://inclinicaltrials.com/depression/NCT05702736/
Evaluating the Utility of a Psychoeducational Serious Game (SPARX) in Protecting Inuit Youth From Depression: A Pilot Study
The goal of this pilot trial was to test SPARX with Inuit youth in Northern Canada. SPARX is an educational video game designed to teach cognitive behavioural therapy strategies and techniques. This "serious game" has previously shown promise in addressing symptoms of depression with Māori youth in New Zealand. Researchers in this study tested SPARX's suitability with Inuit youth in the territory of Nunavut using surveys that youth completed before and after gameplay. Hypothesis 1: Youth who completed SPARX were expected to experience a decrease in depressive symptoms and risk factors related to depression. Hypothesis 2: Youth who completed the SPARX program were expected to experience an increase in factors related to resilience. A team of Nunavut-based community mental health staff facilitated youth's participation in this remote pilot trial with 24 youth aged 13-18 across 11 communities in Nunavut. These youth had been identified by community facilitators as showing low mood, depression, and/or significant levels of stress.
NCT05702086 — Depressive Symptoms
Status: Completed
http://inclinicaltrials.com/depressive-symptoms/NCT05702086/
Neuro MRI Biomarkers for Treatment Navigation in Depression
Background of the study: Major depressive disorder is a severe neuropsychiatric condition that affects approximately 15% to 18% of people worldwide during their lifetime (Malhi & Mann, 2018). Selection of the optimal treatment is difficult. A certain correlation (functional / structural, vascular or a mix of both) is expected between clinical data (obtained from psychometric tests such as the HDRS and psychiatric evaluations) and MRI parameters (functional activity, structural connectivity, anatomical variations, perfusion / diffusion etc.). Objective of the study: Identification of MRI-based biomarkers to predict clinical outcome of major depressive disorder in comparison with healthy controls. Outcome is defined by level of depressive and cognitive symptomatology and related comorbidity. Study design: An independent treating physician will inform a potentially eligible patient and ask whether he/she is interested in voluntary participation in the study. If he/she is interested, the independent treating physician will refer the patient to one of the clinicians from the GGz who is also involved in the Neurotrend study for further steps such as providing the information letter / informed consent and scheduling an intake interview at least one week after receiving all necessary information. Healthy controls will be recruited through public advertisement and via the website www.neurotrend.nl. Pilot subjects will be recruited from the Eindhoven University community and via the website www.neurotrend.nl. Both groups, healthy controls and pilot subjects, will have at least one week to consider and decide on participation. One week later an intake session will take place in which the inclusion and exclusion criteria will be checked. During this session, patients can also ask questions about the study and the informed consent will be signed if the participant is willing to participate voluntarily in the study. Subsequently at the end of the intake session, a starting (baseline) date will be planned for this participant . The actual participation starts at baseline. In total, 120 depressed patients and 60 healthy controls will participate in the study. Each participant visits Kempenhaeghe twice, whereby each session, is dedicated to complete questionnaires and cognitive tests, such as memory tasks and eye tracking. In the last hour, the participant will be scanned (MRI). Two weeks before each visit, the participant has to fill in some questionnaires that have been sent to the participant. Study population: 120 patients with major depressive disorder and 60 healthy controls*. * Inclusion of up to 30 healthy "pilot" participants for technical evaluation. See above. Primary study parameters/outcome of the study: - Hamilton Depression Rating Scale (HDRS) scores - Treatment / medication usage - MRI metrics (varies per MRI modality, an example is volume per region for a T1-weighted scan and fractional anisotropy for diffusion-weighted scans). Secondary study parameters/outcome of the study (if applicable): - Scores of psychometric assessments (e.g. STAI-DY1 - anxiety score) - Scores of cognitive assessments (e.g. average response time for the eye-tracking task) Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): The participant burden is low and is divided into an intake session and two research sessions. The MRI scan is non-invasive, and subjects can indicate that they want to stop the scan at any time during the scan by squeezing a type of balloon that will lie next to the subject in the case that they feel uncomfortable or for any other reason. Subjects with MRI contraindications (e.g. claustrophobia, pregnancy or implants not suitable for MRI) are already excluded in advance and will therefore not participate in the study at all. Mostly, the subjects will lie still during the scan, except for one affective task in which they will be asked to match different emotional faces for about 5 minutes.The cognitive tests will only consist of memory, reaction speed, attention, and processing speed tasks which in total, do not last more than 30 minutes. The risks of the MRI scanner (CE-marked) are minimal.
NCT05701267 — Depressive Disorder, Major
Status: Recruiting
http://inclinicaltrials.com/depressive-disorder-major/NCT05701267/
Effect of Intravenous Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth in Women With Prenatal Depression: 2-year Follow-up of a Randomized Controlled Trial
Postpartum depression refers to the depression after childbirth, which is a common mental disorder in women. The pathogenesis of postpartum depression is not fully understood, and may be related to a variety of factors. Prenatal depression is an important risk factor for postpartum depression. Our recent multicenter randomized controlled trial, "Effect of Low-dose esketamine on the incidence of postpartum depression in women with prenatal depression", explored the effect of immediate postpartum intravenous infusion of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression. The preliminary results showed that it reduced the incidence of postpartum depression at 42 days. Since there were no studies on the effect of intravenous esketamine infusion after delivery on long-term postpartum depression, this study is a long-term follow-up of the previous randomized trial. We aim to explore the effect of low-dose intravenous esketamine after delivery on the incidence of 2-year maternal depression after delivery in women with prenatal depressive symptoms.
NCT05698394 — Postpartum Depression
Status: Active, not recruiting
http://inclinicaltrials.com/postpartum-depression/NCT05698394/