Clinical Research Directory

Analysis of the Therapeutic and Clinical Profile of Cannabinoid Treatments: A Real-World Study

What is the purpose of this study? The use of medicinal cannabis has grown significantly in Brazil. However, because many patients use these products through "compassionate use" (when traditional treatments haven't worked), there is still a lack of large-scale data on how these treatments perform in daily life. This study, called CANAREAL, aims to track patients across Brazil to understand if cannabis-based products are truly effective and safe for treating various conditions, such as chronic pain, anxiety, and depression. How will the study work? This is an observational study, which means the researchers will not provide the medication or change the treatment prescribed by the patient's doctor. Instead, we will simply "follow" the patient's journey for 6 months. What will participants be asked to do? Participants will complete online questionnaires at different stages of their treatment. These tools will measure: Quality of Life: How the treatment affects daily well-being. Clinical Evolution: Changes in pain levels, anxiety, and depression symptoms. Safety: Whether the patient experiences any side effects (adverse events). Why is this study important? Unlike controlled laboratory tests, this "Real-World Study" captures the reality of diverse patients with different backgrounds and health needs. The information gathered will help doctors, patients, and health authorities in Brazil better understand the benefits and risks of cannabinoid therapy, leading to safer and more informed medical decisions in the future.

Couples' Affect in Relationships Study

The goal of this clinical trial is to find out whether learning about well-being impacts the thoughts and feelings of romantic couples. The main question it aims to answer is: * Does gaining knowledge about well-being positively impact individuals and their romantic relationships? Participants will complete online surveys about their thoughts and feelings.

SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety

Advanced liver and gallbladder malignancies (including liver cancer, cholangiocarcinoma and gallbladder cancer) are a type of disease that is difficult to treat, and most patients have a short survival period. In recent years, immunotherapy (such as PD-1/PD-L1 inhibitors) has brought new hope to these patients, but still only a small number of patients can benefit. Research has found that approximately 40% of patients with liver and gallbladder tumors have symptoms of depression and anxiety, which not only affect their quality of life but may also reduce the therapeutic effect by influencing immune function. Fluoxetine is a commonly used antidepressant. The latest research shows that in addition to improving mood, it may also enhance the anti-tumor effect of immunotherapy. This study aims to explore whether fluoxetine combined with immunotherapy can better control tumors than immunotherapy alone, prolong the survival period of patients, and at the same time improve the depressive and anxious symptoms and quality of life of patients.

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.

Cost-effectiveness and Implementation of a Transdiagnostic Internet-based Intervention for Emotional Disorders in Community Care.

Emotional disorders (ED) are one of the leading causes of disability. They are highly prevalent and have an impact on quality of life. Addressing them places an overload on the National Health System (NHS), generating waiting lists and limiting appropriate care. The need for cost-effective solutions has led to the consideration of the transdiagnostic approach and the use of digital solutions. Both perspectives have demonstrated efficacy in a large number of randomized clinical trials. As a result, investment in digital health interventions is on the rise to improve access to care in overburdened healthcare systems. However, their integration and implementation in health systems remains limited. Implementation Science emerges to facilitate the integration of interventions into clinical practice through specific strategies that overcome barriers and optimize their sustainability. The objective of this project is to examine the effectiveness, economic costs and feasibility of implementing an online psychological treatment program for emotional disorders in mental health services. The Mutua and UJI teams have already carried out the transfer of the online program. In order to facilitate the adoption and sustainability of this program and that it can be used by mental health professionals in daily practice, a hybrid design 1 study will be carried out in which not only the efficacy but also the possibility of adoption and the analysis of economic costs in comparison with the usual treatment will be evaluated.

African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Older Adolescents With Depression Delivered Through Senior High Schools in Navrongo, Ghana

The overarching aim of this pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND), delivered by school guidance and counselling coordinators, for the treatment of depression among adolescents in senior high schools in Ghana. The study is a parallel arm cluster randomised controlled pilot trial. We will recruit adolescents aged 15 to 18 years in senior high schools. Participants will be randomised to receive the Y-MIND psychological intervention or enhanced usual care.

Prevalence and Severity of Depression Among Cardiothoracic Surgery Healthcare Workers in Baghdad: A PHQ-9 Cross-Sectional Study

This observational study aims to estimate the prevalence and severity of depression in HCWs in cardiothoracic surgery departments in Baghdad City, Iraq, using a self-administered PHQ-9 questionnaire. The main questions it aims to answer are: What is the prevalence of depression among cardiothoracic surgery healthcare workers? How is the severity of depression distributed within this group? Are there specific occupational or demographic factors associated with higher levels of depression? Participants will: Fill out the PHQ-9 in order to measure the severity of depressive symptoms at a specific moment in time. Demographic and occupational details such as age, gender, years of experience and position held should be taken to look for possible relationship with depression.

Improving the Treatment of Depression Among Youth With HIV

Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness. This proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks.

AI Platform for Fatigue and Depression Detection

This observational study evaluates the accuracy of the Okaya AI platform in detecting fatigue and depression in cardiology patients, comparing its assessments to PHQ-9 and Fatigue Assessment Scale scores.

Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients

This observational study will characterise the general psychiatric and general medical phenotypes of 100 adults, sequentially admitted to NHS General Adult Psychiatry (GAP) "mental health" inpatient wards, providing the first detailed information on morbidity in this patient population.

Evaluate the Effects of Long-term Use of Psychotropic Medications on Eye Movement Patterns With the Gaize Device

The study aims to verify if the Gaize ocular device can effectively identify eye movements indicative of prescribed psychotropic medication usage by employing Drug Recognition Expert (DRE) testing protocols within a controlled virtual environment.

Teen Recovery Through Inspiration, Support, and Empowerment

The goal of this pilot study is to test the effectiveness of a novel intervention for teenagers (ages 15-18) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and to improve mental health recovery by using an online recovery education and support program. The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources. The intervention being tested involves the implementation of an online recovery education and support (RES) program, involving one-on-one and small group meetings led by trained teen peers (TPs) and peer support specialists (PSS). Participants will be assigned to either Cohort A or B for 8 weeks. Cohort A will be the intervention group with online access to an RES, TP, and PSS. * Week 1-4: One-on-one meetings with PSS and TP for education and support. Assessments will be completed at week 2 and 4. * Week 5 and 7: one-one meetings with PSS and TP for education and support. * Week 6 and 8: small group meetings with PSS, TP, and other participants. Assessments will be completed during Weeks 6 and 8. Cohort B will be the SOC group with no PSS, TP, or RES. * Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at Weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and8. Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.

Meditative Neurofeedback for Depression

The goal of this open-label single-arm study is to test a meditative neurofeedback intervention for depressed mood.

Psychiatric Status and Symptom Severity in Graft-versus-Host Disease (GvHD).

This prospective observational study evaluates the association between psychiatric status, GvHD-related symptom severity, and health-related quality of life in patients with graft-versus-host disease. Standardized and validated assessment tools, including the Lee Symptom Scale, will be used to collect psychiatric, clinical, and demographic data.

Enhanced Ward Rounds and Communication for Pre-procedural Anxiety in GI Endoscopy Patients

This study tests a new way to help reduce anxiety in hospitalized patients waiting for therapeutic gastrointestinal (GI) endoscopy procedures, like EMR or ESD. Anxiety before these procedures is common and can make preparation harder, increase medication needs, and affect recovery. We compare standard ward checks (twice a day) to enhanced checks (four times a day) with structured talks and simple relaxation exercises. The goal is to see if the enhanced approach lowers anxiety levels, measured by a standard scale called the Hamilton Anxiety Rating Scale (HAM-A), from baseline to 24 hours before the procedure. Who can join? Adults (18+) scheduled for inpatient GI endoscopy with at least 2 days hospital stay and mild anxiety. Exclusions include emergencies or severe mental health issues. The study is done in hospital wards, with groups assigned by ward periods to keep it real-world. Benefits may include less anxiety and better experience; risks are low as it's just more supportive talks. Participation is voluntary with informed consent. Results could improve hospital care routines.

Validate the Temporal Stability and Responsiveness of AI-COA® for Depression and Anxiety

This study evaluates the reliability and responsiveness of the AI-COA®, a digital tool designed to assess the severity of depression and anxiety. The study compares the tool's performance against standard clinician ratings over 12 weeks to determine its consistency and sensitivity to symptom changes.

Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety

This study is a large-scale pivotal clinical validation of the AI-COA® software device. The purpose is to confirm the tool's accuracy and performance across a demographically diverse population of adults with Major Depressive Disorder (MDD), ensuring it functions fairly and reliably across different subgroups.

Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups

Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes. Evidence supports a complex network between psychosocial factors and glycaemic control that can be highly variable between persons. It is assumed that subgroups exist that show different trajectories of glycaemia and mental health. Belonging to a particular subgroup may be linked with a higher risk of developing mental health problems compared to others. This suggests that it is possible to treat individuals in different subgroups in a manner that optimizes their treatment and can improve health outcomes. Accurate characterisation can inform more individualized care. This calls for a more personalised approach considering the idiosyncrasies of different subgroups. Over 3 years, the investigators have established the basis of a precision mental health approach for diabetes using n-of-1 analyses. By utilizing combined ecological momentary assessment (EMA: repeated daily sampling of psychosocial factors in everyday life) and continuous glucose monitoring (CGM), intensive longitudinal data per person could be collected. This enables the analysis of individual associations between glycaemic parameters and psychosocial variables and identification of individual sources of diabetes distress in each person. The objective of the present study is to use of the n-of-1 approach to identify subgroups of PWD who share common characteristics in the associations between glucose and psychosocial variables. The identified subgroups shall be used to develop a digital twin for precision mental health in diabetes. The digital twin serves as representation of a real person, allowing to make simulations and predictions of the course of mental health and glycaemia. These predictions can inform diabetes care and lead to more precise, personalised treatment decisions. To achieve this, a longitudinal panel including over 1,400 PWD who continuously complete EMA and questionnaire surveys and measure glucose levels using CGM was developed. Over 1000 clinical interviews to diagnose mental disorders have been conducted to identify major mental health conditions and map mental outcomes. To identify subgroups and develop the digital twin, the sampling will be expanded aiming at a total of 1,809 PWD. Incidence and remission of mental disorders will be determined via repeated interviews. The complex networks between clinical, metabolic, and psychosocial data will be analysed using machine learning, leading to new insights with the potential to shape future guidelines. These results will be used by the digital twin to predict courses of glycaemic control and mental health, translating the individual evidence into direct treatment suggestions.

Comparing the Efficacy of Heated Yoga and Sauna as a Treatment for Depression

This project explores whether heated yoga, sauna, and a mindfulness app reduce depressive symptoms

Expansion and Evaluation of AI-generated Clinical Assessment (AI-COA®) of Depression and Anxiety Severity

The SEQUOIA-1 study evaluates the effectiveness of Artificial Intelligence (AI) in measuring depression and anxiety severity in adults. Investigators from Deliberate Solutions, Inc. and Baylor College of Medicine are conducting this study to determine whether AI can provide reliable clinical assessments of mood and anxiety disorders. In clinical trials for new depression and anxiety treatments, human clinicians typically conduct interviews to evaluate participants' symptoms. These assessments are critical but may vary based on the clinician's experience or interview style, potentially affecting the reliability of research findings. To address this challenge, the study team developed an AI-based Clinical Outcome Assessment tool, called AICOA®, which analyzes video interviews to measure symptoms of depression and anxiety consistently and objectively. AI-COA® has been accepted by the U.S. Food and Drug Administration (FDA) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. The primary objectives of the SEQUOIA-1 study are to collect additional data to improve model accuracy and to evaluate model performance across diverse demographic groups. The study also pilots the use of an AI interviewer-an interactive digital agent-to conduct remote assessments. During the study, participants will complete questionnaires about their symptoms and perform brief tasks. Participants will also provide feedback regarding their experience interacting with the AI interviewer. All assessments will be securely video-recorded. Recorded videos will be analyzed by AICOA® to determine depression and anxiety symptom severity. These results will be compared to assessments conducted by human clinicians. The development and validation of reliable, AI-driven assessment tools through this study aim to enhance the accuracy of mental health evaluations, potentially improving the testing and approval processes for new treatments targeting depression and anxiety.

Evaluating and Implementing The CONNECT Program - a Group-Based Telehealth Intervention to Reduce Social Isolation, Loneliness, and Mental Health Symptoms in Adults Ages 55+, Compared to Routine Community-Based Programming

Older adults in Canada are experiencing increasing levels of social isolation, loneliness, and mental health challenges, including anxiety and depression - trends that have worsened during and following the COVID-19 pandemic. Research consistently shows that loneliness and social isolation are associated with poorer mental and physical health outcomes, increased risk of dementia, and increased mortality. At the same time, social connection has a strong protective impact on health and well-being. Community-based programs that promote both social engagement and psychological support are urgently needed, particularly since older adults are less likely to access formal mental health services. Approximately 3-11% of older adults meet diagnostic criteria for mood or anxiety disorders each year, with even more experiencing elevated symptoms that greatly influence quality of life. Subsyndromal depression in late life is estimated to occur two to three times more often than major depressive disorder. Despite these needs, up to 70% of older adults with anxiety or mood disorders do not access psychological services, often due to low mental health literacy or practical barriers to care. At the same time, participation in community activities is associated with improved emotional well-being, greater social support, and lower rates of depression and anxiety. To bridge this need for support, our team developed and pilot-tested The CONNECT Program - a group-based mental health intervention for adults 55 years and older, delivered via telephone or virtually. The CONNECT Program is grounded in Acceptance and Commitment Therapy (ACT), self-compassion, and theories of successful aging, and aims to improve psychological flexibility; reduce loneliness, social isolation, and co-occurring symptoms of depression and anxiety. A Manitoba pilot study (N = 34) demonstrated promising outcomes in terms of feasibility, acceptability, and preliminary effectiveness with the telephone-based group intervention. The current trial will evaluate the implementation and effectiveness of The CONNECT Program in four Canadian provinces (British Columbia, Manitoba, New Brunswick, Saskatchewan), using an implementation-effectiveness hybrid design and a crossover randomized controlled trial. This study compares The CONNECT Program, delivered via telephone or virtually, to routine community programming (i.e., community participation as usual), which may occur in telephone, virtual, or in-person formats. The primary outcome is psychological flexibility; secondary outcomes include loneliness, social isolation, anxiety, depression, emotional support, mental health literacy. Implementation outcomes will be evaluated following the Proctor et al. framework. This trial will contribute evidence on the mental health needs of adults 55+ and the value of low-barrier, community-based programs delivered remotely. Findings will guide further national and international implementation of The CONNECT Program and similar initiatives aimed at addressing the challenges of loneliness, social isolation, and mental health problems in late life.

Clinical Study of Compound Ciwujia Granules in the Treatment of Depression

The purpose of this clinical trial is to evaluate the therapeutic efficacy and safety of Compound Ciwujia Granules in treating depression disorder (heart-spleen deficiency syndrome). The study primarily aims to address the following key questions: * Can Compound Ciwujia Granules effectively alleviate depressive symptoms in patients with heart-spleen deficiency syndrome? * What adverse reactions might participants experience while taking Compound Ciwujia Granules? Researchers will compare Compound Ciwujia Granules to a placebo (a look-alike substance that contains no drug) to see if Compound Ciwujia Granules works to treat depression disorder. Participants are required to complete the following procedures: 1. Take Compound Ciwujia Granules or placebo twice daily for 8 weeks; 2. Continue concomitant SSRIs throughout the treatment period; 3. Return to the hospital for scheduled assessments at Week 4 and Week 8; 4. Complete a 4-week follow-up period after the 8-week treatment phase.

The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury

This clinical trial aims to determine whether beta-band transcranial alternating current stimulation (tACS) can improve impulse inhibition in adolescents with non-suicidal self-injury (NSSI) and to evaluate its safety. The primary questions it seeks to answer are: * Can beta-band tACS significantly reduce the frequency of self-injury and scores on impulsivity scales in adolescents with NSSI? * What discomfort or medical issues may participants experience during tACS intervention? Researchers will compare beta-band tACS with sham stimulation (a procedure that mimics the real stimulation without delivering effective current) to verify its efficacy. Participants will: * Receive two sessions of either tACS or sham stimulation daily, spaced 4 hours apart, for 7 consecutive days (14 sessions in total). * Undergo scale assessments, behavioral tasks, and eye-tracking tests before and after the intervention. * Record any self-injury episodes and adverse reactions, with continuous monitoring and psychological support provided by a professional team.

Enhancing Engagement by Integrating Goals and Concerns That Matter to Patients

The goal of this clinical trial is to learn if adding patients' goals and concerns to measurement-based collaborative care can tailor care and provide a more holistic view of treatment, thereby improving engagement in care among adult patients receiving collaborative care. The main questions it aims to answer are: * Does using a clinical decision support system (which includes an enhanced pre-visit questionnaire and patient-level dashboard) improve patient engagement in the collaborative care model? * Does using a clinical decision support system improve patient and clinician satisfaction with care? Researchers will compare the enhanced collaborative care with traditional collaborative care. Patient participants will complete pre-visit questionnaires before their collaborative care appointments. Responses will be viewed by the clinician and/or patient in a visual dashboard inside the electronic health record.