129 Clinical Trials for Various Conditions
The primary goal of the proposed study is to compare the effectiveness of universal school based screening for adolescent major depressive disorder to the current school process of targeted screening based on concerning behavior.
The objective of this study is to build the Texas Youth Depression and Suicide Research Network to support the development of a Network Participant Registry and characterization of systems and interventions to examine statewide population health outcomes. All 12-13 sites represented in the Texas Child Mental Health Care Consortium (https://www.utsystem.edu/pophealth/tcmhcc/) have been invited to participate in the Texas Youth Depression and Suicide Research Network as "Nodes." 12 Nodes have been selected for this project. Each Node has obtained support of senior institutional leadership including the department chair. Leadership from each Node provided input and edits in the study design process by committee, with a focus on the inclusion of the "end user" in design decisions. Nodes will work closely with the Network Hub leadership to recruit, monitor, and retain participants. This will require active engagement and sustained relationships with clinics within the academic medical center as well as clinics in the community (i.e., psychiatry, psychology, counselling).
Completing evidence-based treatments for depression has been shown to be particularly problematic for Black adolescents. If Black adolescents' depression treatment needs are to be met, the engagement challenges and the factors that lessen the success of treatment in the "real world" must be addressed. The investigators will examine the effectiveness of the Making Connections Intervention (MCI) and investigate key mediators of both engagement and response to treatment for depression. The MCI is a 1-2 session, evidence-based intervention designed to improve engagement, perceived relevance, and treatment satisfaction among depressed, Black adolescents. The study also uses tailored outreach strategies for adolescents and parents by including innovative digital content such as a web page/app along with other digital products. This study will address an important public health issue: How best to connect Black adolescents with depression to treatment in clinically meaningful ways, and how best to deliver evidence-based treatment to them through school-based services.
The purpose of this research study was to find out if the medication known as ketamine could help the symptoms of depression. This drug is approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent; however, it is not approved for use in depression treatment. The FDA allowed the use of this drug in this research study.
This study uses functional magnetic resonance imaging (fMRI) to investigate the effects of two different antidepressant medications (Paxil CR versus Wellbutrin XL) on reward processing in depressed patients who have attempted suicide or are currently experiencing suicidal thoughts.
This is a rater-blinded, randomized controlled trial. All patients will receive esketamine for treatment of Major Depression with Suicidal Ideation (MDSI). Subjects will be randomized (1:1) to receive CBT (computer-assisted) or TAU alone following esketamine.
This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients. A small pilot study (n=22) will be carried out to demonstrate feasibility, using the FDA-approved stimulation site for depression treatment (L-DLPFC). Participants will be offered stimulation at the anterior cingulate cortex (ACC).
The goal of the study is to define and measure biological processes that contribute to the underlying pathophysiologic process of peri-partum depression to be used for identifying those at risk for developing it. This knowledge may also generate novel drug targets for peripartum depression that may be applicable to other types of depression.
The study will adapt and deploy a digital Behavioral Activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. The study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. This research will examine specifically whether an intervention involving an app called Vira, combined with health coaching (GET ActivE) can improve enjoyment for teens coping with depression. Research participants will be randomly assigned to one of two study intervention. One study intervention involves a) downloading an app called Vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. The health coach will use the Vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. The second study intervention involves downloading an app called EARS and responding to a daily question.
This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.
The purpose of this study is to examine the effect of a low-dose ketamine infusion on depression symptoms within the Emergency Department (ED) visit, and healthcare utilization after leaving the ED, when administered in the ED for depression or suicidal ideation.
The nation's trauma care system, which includes trauma center hospitals \& emergency departments, is where over 30 million Americans receive care after traumatic injuries each year. Injury victims are diverse patients who suffer from complications of the initial injury as well as from multiple complex medical \& mental health conditions. Currently, high-quality patient-centered care is not the standard of care throughout US trauma care systems. Injured trauma survivors treated in trauma care systems frequently receive fragmented care that is not coordinated across hospital, emergency department, outpatient, \& community settings. Post-injury care is frequently not individualized to integrate the patient's most pressing post-traumatic concerns \& preferences into medical decision making. The investigators, as a group of front-line trauma center providers, patients, researchers \& policy makers, have been working together for over a decade to integrate patient-centered care into US trauma care systems. The investigators began this work by asking groups of injured patients the key patient-centered question: "Of everything that has happened to you since your injury, what concerns you the most?" The investigators developed scientifically sound assessment tools that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the investigators convened an American College of Surgeons' policy summit that addressed mental health \& patient-centered care integration across US trauma care systems. As part of this policy summit, patient members of our team presented their experiences of traumatic injury \& recovery. While giving injured patients a "voice" at the summit, these narratives did not move surgical policy makers to develop mandates or guidelines for patient-centered care. In contrast, presentations that included information from randomized comparative effectiveness trials \& standardized outcome assessments convinced surgical policy makers to develop US trauma care system policy mandates \& best practice guidelines for post-traumatic stress disorder \& alcohol use problems. Our team now realizes that in order to optimally integrate patient-centered care into US trauma care systems, the investigators must use the best scientific methods that capture the highest-quality data. This PCORI proposal aims to demonstrate that a patient-centered care management treatment that addresses patient's post-injury concerns \& integrates patient concerns \& preferences into medical decision making, while also coordinating care, can improve outcomes of great importance to patients \& their caregivers, front-line providers \& policy makers. This proposal directly addresses two PCORI patient-centered research questions: "After a traumatic injury, what can I do to improve the outcomes that are most important to me?" \& "How can front-line providers working in trauma care systems help me make the best decisions about my post-injury health \& health care?"
RATIONALE: Chemotherapy may affect various factors that can lead to weight gain. PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer.
The investigators are adapting Interpersonal Psychotherapy (IPT-A) for adolescents who are referred to emergency services either for a suicide attempt or for being evaluated as high risk for suicidal behavior. The investigators will recruit 15 adolescents ages 12-19 years who present with a diagnosis of major depression, dysthymic disorder, depression disorder not otherwise specified who have a history of a suicide attempt in the past 2 months or a non-medically lethal attempt that may require psychiatric hospitalization, suicide attempt that is or report current suicidal ideation with a plan/intent, and treat them in an open clinical trial. The treatment will be conducted twice weekly for the first 8 weeks of treatment and then weekly for the remaining 12 weeks of the study. Using feedback from clinicians and participants, the investigators will make further modifications to the manual in preparation for conducting a larger controlled clinical trial.
This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and stress related to cybervictimization. This study will recruit 900 adolescents which will be enrolled in a randomized controlled trial to test iCHART and will be randomized to iCHART or treatment as usual (TAU). Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicidal-related events by 50%, and the effects will be mediated by increases in referrals, treatment engagement, and safety planning. The investigators will use implementation science methods to assess contextual factors (i.e., barriers and facilitators) and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for our predictive algorithm and iCHART to inform future implementation efforts and promote health equity.
Despite increasing suicide rates in adolescents, there remains a paucity of approaches to use to prevent re-attempts. Any hope for breaking the code to prevent youth suicide lies in understanding biological factors that play a role. Evidence suggests that inflammation and immune system dysfunction may be linked to suicide. The investigators will develop immune profiles for adolescents with suicidal behavior and those at risk in order to develop tools that can be implemented for prevention efforts. This study involves blood draws, answering questions, and completing questionnaires - no treatment or intervention is provided as part of this study. Participants will be screened to see if they qualify for this study using questionnaires. Participants will be teens (ages 12-18 years) with recent suicidal behavior, teens at-risk for developing depression, and healthy control teens. Participants complete all study-related tasks four times over a period of 12 months. Electronic surveys will be sent to participants to complete monthly. Both the adolescent and if applicable, their parent (or legally authorized representatives, LARs), will answer questions regarding depression, anxiety, and suicidal thoughts/behaviors.
This project aims to examine the signal of efficacy of ketamine, a rapidly acting medication shown to decrease suicidality in adults in as short as hours or days, as opposed to weeks. The study design is a double-blind, randomized, active-control trial of adolescents (ages 13-18 years) with recent suicidal behaviors (suicide attempt or increased suicidal ideation). All participants must be receiving standard of care treatment which may range broadly from both outpatient and inpatient programs which include clinically indicated psychosocial and/or psychopharmacological treatments. Ketamine/midazolam treatment will occur twice weekly during the first two weeks of the study, followed by weekly assessments through week 12.
This is an open enrollment study to collect data for the optimization of smartphone-based algorithms for the early detection of mental health and suicidal risk in a student population. Approximately 2000 students, ages 8-23, will be recruited by therapists across 30 schools and mental health centers.
Objective: Mental illness is a leading cause of disease burden; however, many barriers prevent people from seeking mental health services. Technological innovations may improve the ability to reach under-served populations by overcoming many existing barriers. The investigators evaluated a brief, automated risk assessment and intervention platform designed to increase the use of crisis resources provided to individuals who were online and in crisis. Hypothesis: The investigators hypothesized that individuals assigned to the intervention condition would report using crisis resources at higher rates than individuals in the control condition. Method: Participants, users of the digital mental health app Koko, were randomly assigned to treatment or control conditions upon accessing the app and were included in the study after their posts were identified by machine learning classifiers as signaling a current mental health crisis. Participants in the treatment condition received a brief Barrier Reduction Intervention (BRI) designed to increase the use of crisis service referrals provided on the app. Participants were followed-up several hours later to assess the use of crisis services.
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.
This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors.
This study evaluates the effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), on the neural networks underlying explicit and implicit suicidal cognition in inpatients with major depressive disorder.
The purpose of the study is to evaluate the efficacy, safety, and tolerability of SLS-002 (intranasal racemic ketamine) in addition to standard of care on symptoms of Major Depressive Disorder (MDD) and suicidality, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.
The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.
The primary study comparing effectiveness for suicidal ideation and/or behavior of two antidepressant medications in depressed patients who have attempted suicide or are currently experiencing suicidal thoughts has been completed. A secondary study component using functional magnetic resonance imaging (fMRI) to investigate different medication effects on reward processing in the same sample is ongoing.
The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.
Despite large-scale, nationwide efforts to better address suicidal behavior in Veterans at high risk, the development of interventions that target some of the key risk factors associated with suicide remains limited. This study aims to collect pilot data to test feasibility/acceptability of a novel adjunctive evidence-based cognitive remediation (CR) therapy with manualized "Bridging" sessions for transfer and practice of problem-solving strategies for real-world stressors, including those that trigger suicidal thoughts. This 10-week (20 session) Neuropsychological Educational Approach to Cognitive Remediation CR+Bridging telehealth intervention will be administered virtually via HIPPA-compliant services to 36 Veterans with major depressive disorder and a history of suicide attempt(s). Pre-, post-treatment, and follow-up assessments of neurocognitive, clinical, social, and real-world functioning also will be conducted. This study has potential for high public health impact and promise to help improve quality of life for Veterans at high risk for suicide.
To explore whether intravenous ketamine followed by buprenorphine produces more rapid and sustained anti-suicidal effects than ketamine followed by placebo, investigators will conduct a single study that will take approximately 2.5 years to complete. 60 subjects (60 infusions) or approximately 24 infusions per year.
Adapt for Life is a mental health and wellbeing program designed to help young people develop healthy behaviors and important life skills to manage stress and mental health challenges. The program is a collaboration between Adapt for Life and Cincinnati Children's Hospital Medical Center. Purpose of the Study: The primary purpose of the Adapt for Life study is to evaluate the effectiveness of the ADAPT framework in improving mental health outcomes for students. The framework includes steps such as Ask, Describe, Assess, Plan, and Talk, which are designed to help students tackle stress during everyday moments or in times of crisis. Question the Study is Trying to Answer: The study seeks to answer whether the ADAPT framework can significantly improve students' ability to manage stress, recognize mental health issues, and seek appropriate help. It aims to determine if the program can reduce instances of harmful behaviors and improve overall mental wellbeing among participants.
Suicide is the second leading cause of death in youth, and recent statistics indicate disproportionate risk for suicidal behavior among Black youth. Despite this, few interventions effectively prevent youth suicidal thoughts and behaviors (STB). Sleep difficulties may be a particularly promising target for youth STB prevention efforts. To date, no intervention targeting sleep difficulties have been examined among youth at-risk for STBs nor tailored to Black youth; this research is critical for maximizing intervention acceptability and impact. The Transdiagnostic Sleep and Circadian Intervention (TranS-C) is an evidence-based, modularized intervention that targets a range of sleep and circadian difficulties, making it especially well-suited for treating adolescent sleep. Delivery of this intervention will be through telehealth with a Sleep Therapist. Youth will wear an actigraphy watch that monitors sleep and will complete daily sleep diaries via smartphone or email; sleep feedback reports of sleep diary and actigraphy data are available on demand after completing a diary entry. The adolescents will also wear bright light glasses in the morning and blue light blocking glasses in the evening. Adolescents will also attend weekly or biweekly sessions with a Sleep Therapist. The Sleep Therapist will review sleep feedback generated from actigraph and sleep diary data with adolescents during sessions. In the Sleep Feedback alone intervention, adolescents will wear an actigraphy watch and complete daily diaries; they are able to view their sleep feedback on demand through user-friendly graphs of naturalistic objective and subjective sleep data.