Resistant Depression and Vagus Nerve Stimulation : a Medico-economic, Multicenter, Randomized and Open Trial
Depression is a common illness, affecting 17% of the population over the course of a lifetime. A third of depressions relapses and progresses to recurrence and resistance to treatments. Despite the optimization of antidepressant medical strategies, 20 to 40% of depressions do not respond to treatment. This is particularly worrying as 6% of non-responder patients will die by committing suicide. Depression has a major impact on quality of life, socio-professional functioning and healthcare consumption. Sometimes, TRD is part of a bipolar illness. In this case, the challenge is even bigger because antidepressants are no well tolerated, further reducing the therapeutic options in case of resistance, the severity and duration of the depressive episodes are the main factors explaining the deterioration of the quality of life and the increasing cost of cares for these patients. The standard treatment for TRD is electroconvulsive therapy (ECT), which results in a response in 60 to 70% of cases after a few weeks of treatment. However, the improvement is often transient and 40% of patients relapse within 6 months of the initial ECT session. Moreover, ECT is often not well tolerated. This therapeutic impasse therefore makes TRD a priority public health target to which it is urgent to provide a realistic medico-economical response. The literature suggests that Vagus Nerve Stimulation (VNS) has unique kinetics of efficacy in depression, particularly in preventing long-term recurrences, and therefore responding to the lack of effective maintenance treatment in TRD. In fact, the benefits of VNS gradually accumulate over 12-24 months, which makes it complementary to more incisive treatments like ECT. Finally, its efficacy-tolerance profile appears to be similar in uni and bipolar TRD, giving VNS a potentially unique place in the therapeutic arsenal in psychiatry. The DepVNS hypothesis is that VNS is a medico-economically efficient therapeutic option to overcome the therapeutic impasse in which patients suffering from uni and bipolar DR currently find themselves due to the frequency of relapses under treatment. The primary objective is to estimate, from a collective point of view, the incremental cost-utility ratio of VNS to treat patients suffering from RD.
NCT05952674 — Treatment Resistant Depression (TRD)
Status: Not yet recruiting
http://inclinicaltrials.com/treatment-resistant-depression-trd/NCT05952674/
Ketamine-Assisted Mindfulness-Based Cognitive Therapy for Depression: A Pilot Study
The purpose of this study is to assess the feasibility of combining IV ketamine, a rapid acting antidepressant, with a course of Mindfulness-Based Cognitive Therapy (MBCT), for the initial and maintenance treatment of depression.
NCT05950711 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT05950711/
Evaluation of the Association Between Depression and Glycemic Control in People With Type 1 Diabetes
Single-center prospective observational pilot study The aim of the study is to evaluate the potential association between the percentage of time spent in the optimal glycemia range and the score obtained in the questionnaires used to screen for depression. The study involves only one visit for each participant. Each participant will be asked to sign the informed consent to the study and, during the visit, the following information will be acquired: parameters, history of diabetes, concomitant diseases and medications, and CGM metrics. The participant will be administered the following questionnaires for the evaluation of depression, patient-reported outcome measure (PROMs) and treatment satisfaction: - Patient Health Questionnaire (PHQ-9) - Center of Epidemiological Studies-Depression Scale (CES-D) - Diabetes Treatment Satisfaction Questionnaire (DTSQ) - Well-Being Index (WHO-5) - Problem Areas In Diabetes (PAID-5) - European Quality of Life, Five Dimension, Five Level (EQ5D5L)
NCT05950477 — Type 1 Diabetes
Status: Recruiting
http://inclinicaltrials.com/type-1-diabetes/NCT05950477/
Relationship Between Major Depression and Periodontal Diseases: Analytical Cross-sectional Study
Background: There are epidemiological and preclinical studies in vivo that support the biological plausibility of the association between periodontal diseases and major depression (DM), through the hypothesis of a "leaky mouth" by periodontitis as a source of neuroinflammation. Therefore, this association should be studied in depth in carefully designed cross-sectional studies in humans to specifically assess this relationship. Objectives: Primary: determine if periodontitis can be associated with the development of DM. Secondary: (1) to estimate the prevalence of periodontal diseases (gingivitis and periodontitis) in patients with and without DM; (2) to determine whether oral, periodontal, and fecal (bacterial, viral, and fungal) metagenomic microbiomes, inflammatory mediators, and intestinal barrier integrity are associated with periodontal and mental health variables. Material and method: A cross-sectional analytical study with two groups is designed: - Control group (without DM): subjects without known mental health pathologies will be included, who present a PHQ-9 index of 5 or less. They will be recruited from the control group of a population-based study PsychoBioma TRIAD (C.P. PSQ-19-2 - C.I. 19/474-E). They will be matched by age, gender, and socioeconomic status. - Group of cases (MD patients): subjects with moderate DM will be selected, characterized by HPQ9 index values of 9 or higher. They will be selected among those patients who attend the Mental Health consultations associated with the San Carlos Clinical Hospital. The study will consist of three visits: - Visit in Mental Health Consultations: in this visit the subject will be evaluated to determine if he meets the eligibility criteria. You will be informed of the purpose of the study and you will be invited to participate and sign the informed consent. After that, a structured clinical interview for the DSM-IV (SCID) will be conducted and the subject will fill in a series of specific scales on a study-specific electronic device [Beck Depression Inventory (BDI); UCLA Loneliness Scale, Center for Epidemiologic Studies Depression scale [CES-D]; Childhood Trauma Questionnaire short form (CTQ-SF); The World Health Organization Quality of Life questionnaire (WHOQOL); Hamilton scale (HAM-D17); Global Assessment of Functioning (GAF) Scale]. - Dental School Visit: Subject will receive a comprehensive periodontal examination. A subgingival microbiological sample, a saliva sample and a blood sample will also be taken. The patient will be given a specific vial to collect stool samples. - At the participant's home: the stool samples will be deposited by the participants at home in the specific collection vial.
NCT05950009 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT05950009/
Personalized Brain Functional Sector-guided rTMS Therapy Targeting DMPFC for Treatment-resistant Depression
Investigators aim to evaluate the safety and efficacy of pBFS-guided rTMS therapy targeting DMPFC for patients with treatment-resistant depression
NCT05948839 — Major Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/major-depressive-disorder/NCT05948839/
Online Psychological Support Group for Patients With Heart Failure and Depression in Promoting Self-care: a Randomized Clinical Trial
Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effective self-care for patients with chronic HF, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. One of the pillars of self-care's education for chronic patients recommended by the Health Ministry is the management of the patient's emotional aspects. These have been undertreated in most studies. The prevalence of depression among patients with HF is high and ranges from 41% to 72%, and the assessment with the BDI-II, which is the gold standard used, is 67%. Patients with HF and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. Also, they present 4 times more risk of rehospitalization/mortality. Faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.
NCT05948241 — Depression
Status: Active, not recruiting
http://inclinicaltrials.com/depression/NCT05948241/
Research and Application of Key Technologies for Early Identification, Risk Warning and Comprehensive Intervention of Adolescent Depression
In order to realize the early identification, risk warning and comprehensive intervention of adolescent depression, this project carried out research on the diagnosis platform of adolescent depression, the construction of suicide risk warning and evaluation system, the development of interpersonal psychotherapy technology (IPT-A), and the rapid intervention technology of robotic navigation repetitive transcranial magnetic stimulation (rTMS). Through the extraction of psychological, peripheral and central biological characteristics of adolescent depression and the establishment of a diagnostic platform, combined with artificial neural network to achieve efficient and accurate identification of high risk of suicide population. Antidepressant drugs combined with psychotherapy and antidepressant drugs combined with rTMS physical therapy were used to improve the clinical effective rate and recovery rate. Finally, a comprehensive prevention and control technology suitable for hospitals, schools and families to participate in.
NCT05945342 — Depressive Disorder
Status: Recruiting
http://inclinicaltrials.com/depressive-disorder/NCT05945342/
Improving Outcomes in Depression in Primary Care in a Low Resource Setting
The OptimizeD study aims to improve outcomes in depression in primary care in India. This study will randomize 1500 patients with moderate to severe depression to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine). The study has two primary objectives: 1. Use patient characteristics to generate a precision treatment rule based on baseline information for predicting in advance what works best for whom (and which patients are unlikely to respond to either treatment and should be referred to specialist care). 2. Conduct a cost-effectiveness analysis by comparing relative costs and effectiveness between those who were randomly allocated to their optimal treatment with those who were randomly allocated to a non-optimal treatment based on the precision treatment rule.
NCT05944926 — Depression
Status: Recruiting
http://inclinicaltrials.com/depression/NCT05944926/
A Pilot Study on the Effectiveness of Schema Focused Group Therapy for Persistent Anxiety and Depressive Symptoms: A Single Case Experimental Design
Rationale: Although there are effective treatments available for anxiety and depression, there is a large group of clients that does not benefit sufficiently from first-choice treatment. For this group of clients, no suitable alternative exists yet. One of the main hypothesis about maintaining factors is that there are underlying personality features that impede recovery. Schema focused therapy (SFT) is a transdiagnostic therapy focusing on underlying personality features. It has been proven to be an effective therapy for people with personality disorders and there are initial indications that SFT is also an effective treatment for anxiety and depressive symptoms. A short-term schema focused group therapy (SFGT) has been developed within GGZ-NHN, which is expected to benefit clients with persistent anxiety and depressive symptoms, but has not yet been studied. Objective of the study: In the present study the effectiveness of short-term SFGT (protocol of De Jager, Burger & Groot) on (1) persistent anxiety and depressive symptoms, and (2) early maladaptive schemas (EMS), experiential avoidance and the mode of the healthy adult will be investigated.
NCT05942495 — Anxiety Disorders
Status: Recruiting
http://inclinicaltrials.com/anxiety-disorders/NCT05942495/
A Clinical Study of Omega-3 on Depression and Cognition
Depression is a serious mental illness, with persistent depression and loss of interest as the main clinical manifestations, and causes varying degrees of cognitive impairment, further leading to impaired social function, and even lead to suicidal behavior. Previous studies on the antidepressant effects of Omega-3 mainly focused on chronic effects, and there was a lack of corresponding rapid response clinical studies. Because of the nature of Omega-3 health products, no clinical adverse effects have been reported. We have previously shown that Omega-3 can produce antidepressant and cognitive improvement effects. This study will carry out different doses (low dose and high dose) and single active ingredient (EPA alone) to observe the antidepressant and cognitive improvement effects of Omega-3 in clinical patients with major depression. The antidepressant effect and cognitive improvement effect of Omega-3 will be further verified to provide evidence for future clinical application.
NCT05941754 — Depression
Status: Enrolling by invitation
http://inclinicaltrials.com/depression/NCT05941754/