Affective Disorder

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.

Researchers are investigating the use of 40 Hz visual stimulation as an add-on method to help improve negative symptoms, including cognitive difficulties, in people with schizophrenia or schizoaffective disorder. The study is a pilot trial comparing a group receiving visual stimulation with a group receiving their usual treatment. The goal is to assess whether this non-invasive brain stimulation method can influence brain activity patterns linked to symptoms and improve mood and cognition. Participants in the experimental group will undergo one hour of 40 Hz visual stimulation each day for five consecutive days using a customized sleep mask with red LEDs flickering at 40 Hz. They will lie down with their eyes closed and be encouraged to fall asleep during the stimulation. The control group will continue their usual treatment without additional intervention. The study includes pre- and post-assessments conducted before the first and after the last stimulation session. EEG brain activity will be recorded during the first and last stimulation sessions. Throughout the study, participants will complete mood and cognitive tests, and trained physicians will assess psychiatric symptoms. The visual stimulation sessions will be monitored for any side effects by asking participants about undesired effects after each session. EEG data will be analyzed to measure brain responses to the stimulation. The total study duration includes multiple assessment sessions before and after the stimulation week, providing detailed information on brain and symptom changes related to the intervention.

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 medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis RA. This study focuses on understanding two main factors influencing pain relief brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinibs impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.

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.

Bipolar disorder BD is a serious mental illness that tends to run in families and affects behavior, thinking, emotions, social interactions, and work. It has characteristics like high prevalence, frequent recurrence, and early onset. Early recognition and diagnosis are challenging but important for better outcomes. This research aims to create a large, high-quality group of BD high-risk individuals by enrolling 400 participants over four years and following them intensively for ten years using an electronic mental health platform. The study will collect various types of data including clinical, genetic, cognitive, neuroimaging, sleep, EEG, eye movement, speech, facial expression, and movement to understand how biological, clinical, and environmental factors interact in BD onset. The study is observational and includes three groups children aged 6 to 18 who have at least one parent with BD, children with atypical depression diagnosed by DSM-5 criteria, and healthy children matched by age and gender without psychiatric family history. Participants will be assessed yearly for four years, including brain scans and multiple follow-ups to track the development of mental illnesses, brain structure and function, cognitive function, sleep quality, quality of life, and genetic features. Participants will be involved in annual evaluations for four years, including clinical assessments and brain imaging. Researchers will monitor the differences in development among the three groups over time. The main outcomes focus on the prevalence of mental illness, brain development, and multi-modal feature changes. Secondary outcomes include cognitive function, sleep quality, quality of life, and genetic differences. This long-term follow-up aims to develop predictive models for BD onset and guide early, personalized interventions for those at high risk.