Depression

Researchers are investigating how balance and walking abilities relate to detailed movement measurements in people with Multiple Sclerosis MS. This observational study focuses on understanding the connection between clinical tests of function and objective biomechanical data. The goal is to identify which movement characteristics best reflect balance, gait, and physical performance challenges faced by individuals with MS. Participants will attend a single laboratory session where they undergo biomechanical analysis using the Vicon motion capture system. They will complete functional assessments of balance, gait, and physical performance, as well as questionnaires about fear of falling and fatigue. Spasticity in the lower limbs will also be assessed during this visit. During the session, participants will perform tests such as the mini-BESTest for balance, Functional Gait Assessment, Short Physical Performance Battery, and a 2-minute walk test. Questionnaires like the Fall Efficacy Scale and Fatigue Severity Scale will be completed. Researchers will analyze these collected data to explore how biomechanical and functional measures relate, aiming to improve assessment tools for MS rehabilitation.

Young adults aged 18 to 25 who experience frequent thoughts about killing themselves are the focus of this study, which evaluates the cost-effectiveness of Attachment Based Family Therapy ABFT compared to Treatment As Usual TAU. Suicide is a leading cause of death among young adults, and current treatments have limited success. This trial aims to determine if involving family through ABFT can better reduce suicidality and improve outcomes, informing clinical guidelines and care practices in Belgium and the Netherlands. Participants are randomly assigned to one of two groups the experimental group receives ABFT as an add-on to TAU, which includes treatments like antidepressants, CBT, or DBT, with weekly ABFT sessions lasting about 16 weeks. The control group receives TAU alone, allowing up to four sessions of systemic family therapy. ABFT focuses on strengthening parent-child attachment bonds to provide a supportive base for young adults, involving parents or caregivers actively in therapy. Throughout the study, suicidality is measured at baseline, immediately after intervention, and at follow-ups 3, 6, and 12 months post-intervention using tools like the Suicidal Ideation Questionnaire Junior. Researchers also assess depressive symptoms, family functioning, attachment, quality of life, and healthcare costs. The trial includes 138 participants across multiple sites, with double-blind randomized allocation. Safety, adherence, and cost-effectiveness are closely monitored during and after the treatment period.

Researchers are investigating the antidepressant effects of 40 Hz light stimulation in adults with Major Depressive Disorder MDD. This study builds on findings from Alzheimers disease research, where 40 Hz flickering light therapy showed promise in halting disease progression and improving cognition. The trial aims to explore whether this non-invasive neurostimulation can similarly benefit patients with depression by inducing neuroplasticity and reducing neuroinflammation. Participants will use a Neurostimulation System NSS device at home for one hour daily over six weeks. The device delivers either a 40 Hz invisible spectral flicker active setting or continuous non-flickering white light sham setting in a double-blinded, randomized placebo-controlled design. After the six-week treatment period, there is a two-week follow-up to monitor ongoing effects. During the study, participants will undergo assessments at multiple timepoints including baseline, weeks 1, 3, 6, and 8. These evaluations include depression severity rating using the Hamilton Depression Rating sub-scale HAM-D6, cognitive tests such as facial expression recognition and memory assessments, sleep quality monitoring, and quality of life questionnaires. Researchers will also analyze EEG data to explore brain activity changes related to treatment. Medication and psychotherapy regimens should remain stable throughout the study period.

This research aims to evaluate the effects of 5-hydroxytryptophan 5-HTP and creatine monohydrate as augmenting agents for the treatment of major depressive disorder MDD that is resistant to standard antidepressants. The study focuses on addressing the potential impact of relative hypoxia on depression through alterations in brain bioenergetics and serotonin synthesis, investigating biological markers linked to depression and antidepressant response. This phase 2 trial involves participants diagnosed with MDD who have not fully responded to selective serotonin reuptake inhibitors SSRIs or serotonin-norepinephrine reuptake inhibitors SNRIs. Participants will be randomly assigned to one of three groups for 8 weeks a low dose group receiving 5-HTP 100 mg twice daily plus creatine 5 g daily, a high dose group receiving 5-HTP 200 mg twice daily plus creatine 10 g daily, or a placebo group receiving matched placebos for both agents. The study will assess the biological and clinical effects of these treatments by measuring brain phosphorus magnetic resonance spectroscopy 31P-MRS, resting state functional connectivity imaging fcMRI, and plasma serotonin levels, aiming to replicate and extend findings from an earlier phase. During the study, participants will undergo clinical assessments including the 17-item Hamilton Depression Rating Scale to monitor changes in depression severity, as well as secondary measures like the Montgomery-Asberg Depression Rating Scale. Brain imaging and blood tests will be conducted to evaluate changes in brain energy metabolism and serotonin. Safety monitoring includes screening for medical conditions and pregnancy, with study visits scheduled over the 8-week treatment period. The total duration of participation aligns with the treatment timeline, and the study uses quadruple masking to ensure unbiased results.

Researchers are investigating how the antidepressant citalopram affects the brains response to emotional information, focusing on the amygdala, a key brain area involved in depression. This study explores how different parts of the amygdala react to positive and negative emotional stimuli, using advanced brain scanning technology to understand the underlying brain mechanisms. Participants will receive a single oral dose of either 20 mg citalopram or a placebo in a randomized, double-blind design. After dosing, participants will undergo high-strength 7T fMRI brain scans while viewing emotional faces. This precise imaging allows researchers to observe how citalopram influences specific subfields of the amygdala during emotional processing. Participants will be screened for medical and psychiatric health before joining. During the study, brain activity and behavioral responses such as accuracy and reaction time during a gender discrimination task will be measured about three hours after dosing. The study includes safety monitoring and lasts for a few hours on the study day, focusing on neural and behavioral outcomes related to emotional processing.

Researchers are investigating whether the enzyme phosphodiesterase 4B PDE4B is reduced in the brains of people with major depressive disorder MDD experiencing a major depressive episode MDE. This study will also explore how well a new radioactive tracer, 18FPF-06445974, can measure PDE4B in the brain, including the best scan length and reliability, as well as how PDE4B levels relate to clinical rating scales. Additionally, the study will assess if PDE4B binding can be blocked by the drug apremilast. Participants will undergo up to five clinic visits including screening, physical exams, blood tests, and heart function tests. Imaging involves MRI scans followed by PET scans where the radioactive tracer is injected intravenously through a catheter. During the PET scan, participants will be monitored closely, including blood pressure and heart rate, and blood samples will be collected via a wrist artery catheter. Some participants may have a second PET scan, a lung scan immediately after the brain scan, or receive oral apremilast to evaluate PDE4B blocking. Throughout the study, participants will complete psychiatric assessments and questionnaires about their mental state. Researchers will measure PDE4B distribution volume in the brain and examine its correlation with clinical symptoms. Safety monitoring includes vital signs before, during, and after PET scanning. The study aims to complete within several years, with the primary outcome focused on measuring PDE4B density and related scan parameters to better understand MDD.

Researchers are evaluating a community health worker-delivered mental health counseling intervention delivered remotely via a mobile health app to reduce anxiety and depression among people living with HIV in Florida. This pilot randomized controlled trial aims to assess the preliminary effectiveness of this adapted positive affect counseling approach compared to the standard version of the app and usual mental health care. The study is sponsored by the University of Florida and focuses on improving mental health outcomes in this population. Participants will be randomly assigned to one of two groups. The intervention group will receive approximately five weekly 60-minute individual counseling sessions via secure video calls through a modified PositiveLinks app that includes enhanced mental health resources. If symptoms do not improve, participants may be referred to a licensed mental health professional. The control group will use the standard PositiveLinks app, which provides feedback on anxiety and depression symptoms and a list of local mental health resources without counseling. During the study, data will be collected from participants electronic medical records and the app for about six months after enrollment. Researchers will measure changes in anxiety and depression levels at three months as primary outcomes. Participants will provide informed consent before joining, and there is no masking or blinding in the trial. The study will monitor mental health symptoms and the use of counseling through app data and medical records to evaluate the interventions preliminary effectiveness.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units ICUs. These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder PGD, post-traumatic stress disorder PTSD, and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation SC that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the interventions effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

Researchers are investigating the effects of the PAX Good Behavior Game GBG in Swedish primary schools to address growing concerns of mental health issues among children and stress-related symptoms in teachers. This cluster-randomized controlled trial involves 28 schools and about 84 teachers, aiming to improve student well-being and reduce teacher stress. The study compares PAX GBG to active control interventions that also provide teacher training but with different content. The trial includes extensive measurements over two years, including self-assessments, classroom observations, sound level monitoring, sick leave data, and qualitative interviews. Teachers randomized to the PAX GBG group receive a two-day training on ten specific tools designed to promote prosocial and focused behaviors in classrooms, including a team-based game rewarding good behavior. Control schools choose between two alternatives Count On Me, a math fluency application for pupils, or a Collegial Learning Community intervention focused on professional development for teachers. Both groups receive similar amounts of training and supervision, including multiple sessions during the school year. The interventions are integrated into regular classroom activities starting in grade 1 through grade 3. Participants include approximately 2200 pupils and their teachers, with data collected through various methods such as questionnaires, standardized tests, observer ratings, and registry data. Measurements occur at multiple time points over two years, focusing on pupil well-being, teacher stress, classroom behavior, noise levels, and implementation fidelity. The study also evaluates cost-effectiveness by comparing health outcomes and related expenses. Safety and adverse events are monitored through teacher reports and interviews, ensuring comprehensive assessment of the interventions impact.