Bipolar Disorder

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.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

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.

Suicide is the second leading cause of death among youth, and rates in the US are rising despite prevention efforts. Researchers are evaluating a digital platform called Vira to improve how care is delivered to adolescents at high risk for suicide. This platform aims to use smartphone data and secure communication tools to better understand and manage risk factors like psychological distress, anhedonia, behavioral withdrawal, and sleep problems in young people receiving intensive outpatient treatment. The study compares two groups of adolescent patients aged 13 to 18 years old who are in an intensive outpatient Dialectical Behavior Therapy (DBT) program. One group uses the Vira platform, which collects data passively from smartphone sensors about activity, sleep, mobility, and mood-related language. Vira also prompts daily check-ins and supports practitioners with reminders to encourage behavior changes. The other group receives the usual treatment with the addition of a passive monitoring app called EARS. Participants will use their assigned app during their intensive outpatient treatment. Researchers will assess outcomes using tools like the Columbia Suicide Severity Rating Scale and Scale for Suicidal Ideation over six months. Other measures include anxiety, risky behaviors, sleep quality, mood, and pleasure scales at three and six months. The study monitors clinical outcomes to determine if the digital platform enhances care for youth at risk of suicide.

Researchers are evaluating the effectiveness and feasibility of Narrative Enhancement and Cognitive Therapy (NECT), a group-based treatment designed to reduce self-stigma in people with mental disorders. Self-stigma involves internalizing negative stereotypes which can harm treatment adherence, self-esteem, quality of life, and increase despair or suicide risk. This pragmatic, multicenter, randomized controlled trial includes 416 patients from 26 mental health centers in Northeast Italy, aiming to improve psychological outcomes like self-esteem, hope, empowerment, recovery perception, and mental well-being. Participants in the intervention group will attend 20 one-hour NECT group sessions divided into five parts: orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion. The therapy helps challenge stigmatizing beliefs and fosters a positive self-narrative. This group therapy is provided alongside participants' usual care, which may include medication and psychosocial treatments. The control group will continue their standard care without NECT. The study lasts about 12 months, with a 2-month recruitment phase, 5 months of intervention, and 5 months for data analysis and publication. Participants will undergo assessments at enrollment and after the 20-week intervention to measure changes in self-stigma, self-esteem, hope, empowerment, recovery perception, mental well-being, and stigma-related stress. Treatment fidelity will be monitored through session recordings. The study also tracks feasibility by evaluating participation rates and feedback. All participants remain under their usual care throughout the study, and data collection includes monitoring care received during the trial.

Researchers are evaluating a culturally-responsive mental health engagement program designed for young adults from racial and ethnic minority groups who are enrolled in community-based mental health services. This study aims to test new components added to the existing "Just Do You" intervention, which previously showed promise in keeping young adults connected to their treatment. The trial focuses on improving engagement and increasing mental health service use among these diverse young adults over a 24-month period. The trial will recruit 80 young adults aged 18 to 34 from minority groups receiving outpatient psychiatric rehabilitation services. All participants will first receive the core Just Do You program, which uses creative arts and a team including a licensed clinician and a peer professional to support recovery and mental health literacy. Participants will then be randomly assigned to one of eight groups receiving different combinations of three new culturally-responsive components addressing cultural identity, motivation, and environmental factors. Each participant's intervention will last up to five weeks. During the study, participants will complete baseline assessments, followed by evaluations immediately after the intervention and at a 3-month follow-up. Researchers will measure participant acceptability, qualitative feedback, adherence to the intervention, and mental health service use. Engagement with child protective services will also be assessed. The study seeks to understand how these new components support ongoing connection to mental health care over an average of two years.

Researchers are investigating the effects of a multidomain lifestyle intervention to slow cognitive decline and dementia risk in elderly residents aged 60 to 80 in Zhejiang Province, China. The study builds on findings from Finland, where a similar approach combining physical activity, nutrition, cognitive training, social activities, and vascular risk management showed promise in healthy older adults at risk of cognitive decline. This trial aims to explore how such an intervention may change brain structure and function as well as cognitive abilities in an Asian population. Participants are randomly assigned to either a structured multidomain intervention group or a self-guided control group. The intervention group receives tailored nutritional guidance, cognitive training, physical exercises, and vascular risk monitoring, all adapted to Chinese cultural norms. The control group receives regular health education campaigns and basic health monitoring every 6 to 12 months. This trial runs for two years with ongoing assessments to evaluate the impact of these lifestyle changes. During the study, participants undergo various evaluations including cognitive tests measuring global and domain-specific cognition, neuroimaging scans like MRI and fMRI, laboratory blood tests, and physical performance measures such as grip strength and gait speed. Questionnaires assess quality of life, depression, sleep quality, and daily activities. Researchers also monitor cardiovascular health, dementia onset, and falls. This comprehensive monitoring will help determine the intervention's effects on brain health and daily functioning over the 24-month period.

Researchers are evaluating the effects of a smartphone-based Healthy Lifestyle (HLS) intervention on the mental and physical health of firefighters in Tainan, Taiwan. This cluster randomized controlled trial aims to determine if the Traditional Chinese version of the HLS mobile app can improve firefighters' health compared to usual care. The study also seeks to find out whether the intervention can promote a healthier lifestyle and reduce the risk of chronic non-communicable diseases among firefighters. Participants will be randomly assigned to either the intervention group, which uses the Traditional Chinese HLS mobile app designed specifically for firefighters, or the control group, which receives usual care. The intervention period lasts from 3 to 6 months, during which firefighters in the intervention group will use the app to support healthier behaviors. The control group will continue with their standard practices without the app. Throughout the study, firefighters will undergo health and fitness assessments at the start and again 3 to 6 months after the intervention begins. Measurements include blood pressure, depressive symptoms, PTSD symptoms, body mass index, smoking habits, diet patterns, physical activity levels, sitting time, sleep duration and napping frequency, glycated hemoglobin, lipid profiles, C-reactive protein, and physical performance. The study will monitor these outcomes to assess changes in mental and physical health. Safety and progress will be observed through these regular evaluations during the study period.

Researchers are evaluating a peer-delivered recovery program called SUPPORT designed for Veterans with serious mental illness (such as psychotic and bipolar disorders) who are at increased risk of suicide. The study aims to improve functional and social recovery and reduce suicide risk by tailoring recovery planning to each Veteran's suicidal experiences. This intervention is an adaptation of the Wellness Recovery Action Plan (WRAP) and uses cognitive learning strategies to help Veterans recall their safety plans and improve functioning. The 5-year study has two phases: Phase 1 focuses on refining SUPPORT using input from Veterans and experts and training Peer Specialists. Phase 2 is a pilot randomized controlled trial comparing SUPPORT to enhanced standard care (ESC), which includes usual suicide prevention measures plus additional research contacts. SUPPORT is delivered weekly in 50-minute sessions by Peer Specialists who work closely with each Veteran to create a personalized recovery plan. The ESC group receives standard suicide risk assessments, safety planning, mental health referrals, and follow-up contacts. Participants are assessed quantitatively at baseline, mid-treatment, post-treatment, and 3 months post-treatment, with additional qualitative interviews after treatment. Peer Specialists are also interviewed after delivering the intervention. Researchers measure the feasibility of recruitment and retention, participant satisfaction, and changes in suicidal thoughts and recovery. The study is sponsored by the VA Office of Research and Development and involves ongoing monitoring over about four years.

Researchers are evaluating the effects of azetukalner in adults diagnosed with bipolar I or II disorder who are currently experiencing a depressive episode, also known as bipolar depression. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of azetukalner in this population. Participants must have had their first major depressive episode before age 50 and meet specific diagnostic criteria confirmed by clinical interview. Participants will be randomly assigned to receive either azetukalner 20 mg or a placebo orally once daily with food, preferably with the evening meal, for six weeks. The study has two groups: one receiving the experimental drug and one receiving a placebo, both taken over the same period. The study is designed to keep participants and researchers unaware of the group assignments to ensure unbiased results. Throughout the trial, participants will be evaluated using various measures, including changes in depression severity assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and at week 6, along with other scales at different time points. Safety and response will be monitored regularly during the six-week treatment period. The entire participation period is focused on this treatment phase, with assessments conducted to measure changes in symptoms and overall condition.