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71 active trials for Depressive Disorder

Music After Stroke To Enhance Rehabilitation

Music that is familiar and preferred by patients has been shown to heighten neuroplasticity and can mitigate these disabilities. Therefore, this study seeks to explore the effect of providing patient preferred music to patients in the very early post stroke period (within 24 hours of a left cerebral artery stroke [LMCA]event) as a complementary modality to usual stroke care.

Start: April 2021

Harnessing Mobile Technology to Reduce Mental Health Disorders in College Populations

The prevalence of mental health problems among college populations has risen steadily in recent decades, with one third of today's students struggling with anxiety, depression, or an eating disorder (ED). Yet, only 20-40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach for detecting mental health problems and engaging college students in services. The investigators have developed a transdiagnostic, low-cost mobile health targeted prevention and intervention platform that uses population-level screening for engaging college students in tailored services that address common mental health problems. This care delivery system represents an ideal model given its use of evidence-based mobile programs, a transdiagnostic approach that addresses comorbid mental health issues, and personalized screening and intervention to increase service uptake, enhance engagement, and improve outcomes. Further, this service delivery model harnesses the expertise of an interdisciplinary team of behavioral scientists, college student mental health scholars, technology researchers, and health economists. This work bridges the study team's collective leadership over the past 25 years in successfully implementing a population-based screening program in more than 160 colleges and demonstrating the effectiveness of Internet-based programs for targeted prevention and intervention for anxiety, depression, and EDs. Through this study, Investigators will test the impact of this mobile mental health platform for service delivery in a large-scale trial across a diverse range of U.S. colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or EDs (excluding anorexia nervosa, for which more intensive medical monitoring is warranted) and who are not currently engaged in mental health services will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center). Participants in the study will be enrolled for 2 years and asked to complete surveys at baseline, 6 weeks, 6 months, and 2 years.

Start: October 2019

Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform

Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. Lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in ART. As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care, and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes. The investigators will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini International Neuropsychiatric Interview (MINI). Rollout will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g. HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every three months through 12-month follow-up. The investigators will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model. This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. The investigators will also look at the indirect effects of the intervention at the household level. The investigators' hypothesis is that the intervention will be effective at reducing depression symptoms, improving physical health, and improving household members' wellbeing, compare to treatment as usual. The investigators also hypothesize that the intervention will be highly cost-effective, meaning that the cost per QALY gained will be less than Malawi's median GDP per capita. If determined to be effective and cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.

Start: July 2021

Preoperative Ketamine and Perioperative Depression

Depressive symptoms, in patients with a life history of major depressive disorder (MDD), are very common in the general population, and are especially so in elderly adults undergoing surgery.Symptoms of depression at the time of surgery is associated with risk for postoperative complications.Attenuating depressive symptoms in patients undergoing surgery is thus a plausible but not adequately tested strategy for improving patient postoperative outcomes. Conventional treatment of depression takes weeks and, therefore, is not always a realistic option, particularly when surgery is urgent. Importantly, there are currently no guidelines for diagnosing and managing MDD in surgical patients. Given its association with complications including perioperative cognitive disorders such as delirium, and over longer periods of time with dementing disorders, the feasibility and efficacy of quick-acting treatments for depressive symptoms in surgical patients are direly needed. This need is particularly acute given the rising number of elderly patients undergoing surgery who are prone to depression and surgical complications. Aim 1: To assess the feasibility of enrolling patients in a clinical trial where a sub-anesthetic dose of ketamine (0.5 mg/kg over 40 min) or midazolam (0.045 mg/kg) is given 1 to 3 days before surgery in the preoperative clinic as a strategy to improve depressive symptoms during the perioperative period. Aim 2: To obtain estimates of the variability in improvements of depressive symptoms (increase from baseline in MADRS score ? 2)1 day after surgery for patients given a sub-anesthetic dose of ketamine (0.5 mg/kg over 40 min) 1 to 3 days before surgery compared with midazolam 0.045 mg/kg. Aim 3: To assess for the safety and tolerability of administration of a sub-anesthetic dose of ketamine (0.5 mg/kg over 40 min) given 1 to 3 days before surgery in the preoperative clinic (as an outpatient) by assessment of dysphoric symptoms or other complications including the need for hospitalization. Hypothesis: Aim 1: Hypothesis: Patients with preoperative depressive symptoms can be identified before surgery and successfully enrolled in a clinical trial comparing a sub-anesthetic dose of ketamine versus midazolam for improving perioperative depressive symptoms. Aim 2: Hypothesis: Compared with midazolam, a sub-anesthetic dose of ketamine given preoperatively leads to an improvement in MADRS score ? 2 on day 1 after surgery. Aim 3: Hypothesis: Compared with midazolam, a sub-anesthetic dose of ketamine is not associated with dysphoria or other complications.

Start: March 2021

Treating Adolescents With CBT and OBH

The purpose of this study is to examine various behavioral, social, and emotional changes that result from engaging in an OBH and CBT treatment program designed for adolescents.

Start: February 2021

The Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation and Oxidative Stress Parameters and Faecal Microbiota in Patients With Depression Depending on Metabolic Syndrome Comorbidity

The trial will be a four-arm, parallel group, prospective, randomized, double-blind, controlled design that will include 200 participants and will last 20 weeks. The probiotic preparation will contain Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175. We will assess the level of depression, anxiety and stress, quality of life, blood pressure, body mass index and waist circumference, white blood cells count, serum levels of C-reactive protein, HDL cholesterol, triglicerides, fasting glucose, faecal microbiota composition and the level of some faecal microbiota metabolites, as well as inflammation markers and oxidative stress parameters in serum. The trial may establish a safe and easy-to-use treatment option as an adjunct in a subpopulation of depressive patients only partially responsive to pharmacologic treatment.

Start: December 2020

The Danish Neuropsychological Study on the Adverse Effects of ECT

The main purpose of this study is to determine whether electroconvulsive therapy (ECT) causes any structural or functional brain changes and thus indicating its mechanism of action. The second aim is to find predictors of an immediate response, sustained remission, relapse and side-effects. Thirdly, this study aims to explore whether ECT causes any changes in blood-brain barriers permeability and whether these changes correlate to memory problems. The fourth objective is to examine whether ECT causes any brain tissue damage.

Start: November 2020

Telephone-administered Relapse Prevention for Depression

This study determines the effectiveness of telephone-delivered cognitive-behavioral continuation therapy (T-CT) in comparison to usual care in people with recurrent or chronic depression. The primary research question is whether participating in T-CT reduces depressive relapses. The continuation therapy comprises eight therapy sessions delivered over the telephone by a trained therapist over a period of approximately six months following acute-phase psychotherapy.

Start: September 2017

Cooperation for Primary Care Patients on Sick Leave for CMD: Care Manager and Workplace Intervention - CO-WORK-CARE

This study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the Primary Care Centre Rehab Coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with a Care Manager during the period of sick leave. The study will be performed as a randomised controlled trial with randomisation at the PCC level where intervention PCCs offers a convergence dialogue meeting with the work place representative during sick leave in addition to Care Manager contact.

Start: December 2017

Imaging to Improve Brain Stimulation

This study investigates how brains change as a result of a treatment for depression called repetitive transcranial magnetic stimulation (rTMS). People who receive rTMS will have pictures of their brains and brain activity taken by a magnetic resonance imaging (MRI) scanner before and after their treatment, as well as up to three times during the six-week treatment course. These images will be examined to see if the rTMS is placed correctly to help treat their symptoms, and what changes in brain activity are happening during the rTMS treatment

Start: October 2019

Brief Transdiagnostic Group CBT for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial

We will evaluate a brief group-based cognitive-behavioral treatment program for adolescents aged 13-17 years with internalizing problems.

Start: October 2020

Depressed Mood Improvement Through Nicotine Dosing 2

Deficits in cognitive control are core features of late-life depression, contributing both to emotion dysregulation and problems with inhibiting irrelevant information, conflict detection, and working memory. Clinically characterized as executive dysfunction, these deficits are associated with poor response to antidepressants and higher levels of disability. Improvement of cognitive control network (CCN) dysfunction may benefit both mood and cognitive performance, however no current pharmacotherapy improves CCN deficits in LLD. Supported by pilot data, Investigators propose that nicotine acetylcholine receptor agonists enhance CCN function and resultantly improve mood and cognitive performance in late-life depression. The objective of this initial R61-phase trial is to first determine whether transdermal nicotine enhances CCN neural activity in an exposure-dependent fashion during an emotional response inhibition task (the emotional Stroop task). Investigator's approach for the R61 phase is to examine in 36 older adults with Major Depressive Disorder whether transdermal nicotine patches enhance CCN activity over 12 weeks as measured during fMRI with the emotional Stroop task while measuring nicotine and nicotine metabolite levels. Transdermal nicotine has a mechanism of action that is distinct from current antidepressants, potentially making it a potentially important antidepressant augmentation agent. If hypotheses are correct, as patches are commercially available, this approach could be rapidly moved into definitive studies and may have applicability to other psychiatric disorders characterized by CCN dysfunction.

Start: December 2020

Study of Morphological and Perfusion Imaging Predictors of Pejorative Outcome in Major Depressive Disorder

Depression is a debilitating illness with a risk of developing a treatment resistant form. Currently, diagnosis is purely clinical with little features available to identify potentially adverse developments. Clinical features such as early onset age, prolonged episodes, anxiety, somatic symptoms and apathy are all arguments raising fears the onset of resistance to conventional treatments. According to neuroimaging knowledge about the pathophysiological mechanisms, involving front-limbic functional networks supporting the functions of emotional regulation and reward system, recent work has focused on the identification of neuroimaging biomarkers predicting therapeutic response. Among the regions of interest identified, the anterior cingulate cortex, amygdala, hippocampus, and regions participating in the Default Mode Network Training (Medial prefrontal cortex, posterior cingulate cortex, inferior parietal lobe) are most frequently areas associated with the prediction of therapeutic response. Limitations most reported in these studies are the heterogeneity of experimental paradigms (resting state, cognitive or emotional functional tasks), imaging (PET scan, MRI) the heterogeneity of clinical resistance criteria forms studied, different techniques (as that we consider remission (threshold score) or response (50% decrease from baseline score), and the sample size. Knowing that MRI into daily clinical practice in the SHU of Adult Psychiatry, as the balance sheet of the disease, monitoring its evolution, as in assumption rTMS (repetitive Transcranial Magnetic Stimulation) (pretreatment assessment and neuro), the identification of neuroimaging biomarkers in a population of patients with clinical criteria of Mood Depressive Episode, with an acquisition of identical and reproducible image daily routine methodology appears to be a reliable way to correct the heterogeneity of conventionally published studies on the topic. This study aim to identify, in routine care, predictive clinical and neuroimaging markers of poor outcome in major depressive disorder.

Start: November 2014

Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.

Start: March 2019

Intervention to Prevent Peer Violence & Depressive Symptoms Among At-Risk Adolescents

The purpose of this investigation is to test the efficacy of "iDOVE2" (a brief emergency department introductory session and longitudinal automated text-message depression prevention program for high-risk teens), and to determine the most potent and parsimonious combination of intervention components for preventing peer violence and depressive symptoms among at-risk youth.

Start: August 2018

Delivering iCBT to Address Mental Health Challenges in Correctional Officers and Other Public Safety Personnel

Public safety personnel (PSP) have regular and often intense exposure to potentially traumatic events at work and are at higher risk for developing mental health problems such as posttraumatic stress disorder (PTSD). Studies have shown up to 4 times higher suicidal ideation, attempt and death among this population compared to the general population. Despite the high rate of mental health problems among PSPs, their willingness to receive mental healthcare support is fairly low, mainly due to the stigma attached to these disorders. Those who are willing to seek help face unique barriers including their irregular shift hours, limiting their access to resources otherwise available to the public. Given these challenges and the critical contribution of PSPs to public safety, developing innovative solutions to address their mental health must be a healthcare priority. This proposal aims to study the efficacy of using an innovative approach in delivering mental health online, to address mental health problems among correctional workers (CW), who are especially prone to mental health problems given the high rate of workplace violence. It is hypothesized that using an online platform to deliver cognitive behavioural therapy (CBT), would lower the stigma of receiving care in a secure and confidential environment, easing CW's concerns about stigma from co-workers. The content is delivered through interactive and engaging therapy modules, designed for specific groups of CWs and customized by situational examples to make therapy more relatable. These online modules would provide CWs with 24/7 access to therapy content, solving the irregular work hour problem. The online CBT modules developed in this study would provide high quality and clinically validated resources to address mental health problems of CWs all across Canada. Knowledge acquired through this project could also be beneficial to using iCBT in general for addressing mental health challenges among other PSPs.

Start: July 2020

Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder

Lycium barbarum, a traditional Chinese herbal medicine, is a commonly used herb in the traditional Chinese pharmacopoeia. Its main active ingredient, lycium barbarum polysaccharide (LBP), is reported to have neuroprotective effects. Animal studies suggested that LBP has neuroprotective effect on optic ganglion cells. In animal models of depression, LBP can improve depressive symptom by improving synaptic plasticity. However, its clinical effect remains to be studied. We will conduct a 6-week double-blind, randomized, placebo-con-trolled trial in patients with major depressive disorder (MDD). The purpose of this clinical trial is to investigate the efficacy of LBP in patients with MDD.

Start: November 2019

An Adaptive Algorithm-Based Approach to Treatment for Adolescent Depression

The purpose of this study is to evaluate the effectiveness of two adaptive treatment strategies (ATSs) for adolescent depression. The ATSs include delivery of an evidence-based psychotherapy (interpersonal psychotherapy for depressed adolescents, IPT-A), systematic symptom monitoring, and an empirically-derived algorithm that specifies whether, when, and how to augment IPT-A. Two hundred depressed adolescents (age 12-18) will be recruited to participate in a 16-week sequential multiple assignment randomized trial conducted in outpatient community mental health clinics. Adolescents will be randomized to the IPT-A ATS condition or the community clinic's usual care (UC). Adolescents in the IPT-A ATS condition who are insufficient responders will be randomized a second time to the addition of a selective serotonin reuptake inhibitor (SSRI) or more intensive IPT-A (delivered twice per week). Research assessments will be administered at baseline and at weeks 4, 8, 12, 16, and 36.

Start: February 2018

Mobile Health of Lifestyle to Patients With Cardiac Electronic Implantable Device: Randomized Clinical Trial (MHOL-CEID )

Previous studies suggested that most patients with Cardiac Electronic Implantable devices have a perception of describing the lifestyle due to a limitation of daily activities and physical exercise, besides the consequences in the psychological aspects such as anxiety and depression. The MHOL-CEID is a randomized controlled trial that Verifies the effectiveness of the Mobile Health of lifestyle that focuses on aspects of physical functional, psychosocial, and quality of life of patients with Cardiac Electronic Implantable Device.

Start: May 2018

Self and Body-esteem in Socio-professional Rehabilitation

The body esteem influences the physical appearance, which can be a social brake. To enhance the socio-professional insertion of persons with severe mental disorders, the investigators developed a group program about self-presentation and body esteem. The study's objective is to understand the body esteem impact on socio-professional insertion, and how to improve that with a dedicated group program, for patients in a psychosocial rehabilitation center

Start: June 2020