Psychosis

This research aims to evaluate whether taking antipsychotic medication every other day is as effective as the usual daily dosing for people with schizophrenia or related disorders. The study also explores if the alternate day dosing reduces side effects compared to daily treatment. It is a randomized, double-blind trial designed to compare these two dosing schedules over one year. Participants will be randomly assigned to either continue their current daily antipsychotic medication risperidone, olanzapine, or paliperidone or switch to an alternate day dosing schedule. To maintain blinding, active medication and placebo capsules are provided in matching blister packs so participants and staff cannot tell which regimen is assigned. Doses range from 1 mg to 16 mg for risperidone, 5 mg to 20 mg for olanzapine, and 3 mg to 12 mg for paliperidone. Treatment is individualized, and other psychotropic medications can continue if stable. Participants will attend 22 visits over 52 weeks, with visits every two weeks for the first six months and monthly visits for the final six months. Researchers will assess symptom severity and side effects using several scales, including the Brief Psychiatric Rating Scale and multiple symptom and wellbeing questionnaires. The main outcome focuses on clinical deterioration at the start and end of the study. Safety and medication adherence will be closely monitored throughout the trial.

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.

Cognitive impairment related to dementia is often missed in primary care, especially among older adults from minority and socio-economically disadvantaged populations. Researchers are evaluating the 5-Cog brief cognitive assessment, a quick, simple, and standardized tool that takes less than 5 minutes and addresses cultural and logistical barriers. This pragmatic cluster-randomized trial aims to test whether the 5-Cog paradigm improves detection of new cases of cognitive impairment and dementia care in older adults with cognitive concerns. The study involves 22 primary care clinics in Bronx and Indiana, enrolling about 6,600 patients aged 65 and older who report cognitive concerns. Participants receive either the 5-Cog battery combined with a clinical decision-making tool or enhanced usual care, which includes cognitive concern screening. The 5-Cog battery includes tests like Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match. Primary care physicians receive results and decision support but use their clinical judgment in care decisions. Participants undergo cognitive concern screening before their appointments. Researchers will review new cognitive impairment diagnoses and improvements in dementia care within 90 days after the primary care visit using electronic medical records. Additional evaluations include tests for reversible causes, medication changes, specialist referrals, and social support. The study also examines the 5-Cog paradigms implementation and cost-effectiveness, focusing on populations facing health disparities. Total participation duration varies by patient and clinic schedule.

Researchers are evaluating the long-term safety and tolerability of LB-102 in adults with stable schizophrenia who have had inadequate responses, side effects, or issues with their current antipsychotic medications, or who have completed prior LB-102 studies. This Phase 3, open-label, multicenter trial focuses on patients aged 18 to 65 years with stable disease and aims to provide extended monitoring of this treatment. Participants will receive LB-102 with flexible dosing ranging from 50 mg to 100 mg. This single-group study involves administering the drug openly over 52 weeks to assess how well patients tolerate it and to monitor safety during this period. Throughout the study, participants will undergo evaluations including monitoring adverse events and treatment-emergent events. Effectiveness will be assessed using the Positive and Negative Syndrome Scale PANSS. The study lasts up to 52 weeks, during which safety and tolerability are carefully observed and recorded.

This research investigates long-term clinical, cognitive, and functional outcomes in individuals diagnosed with schizophrenia or related psychotic disorders, focusing on the effects of early treatment choices and relapse patterns over 20 years. It aims to understand how early medication decisions and episodes of relapse influence these outcomes, and to explore factors leading to medication discontinuation and poor prognosis after first-episode psychosis. The study involves a one-time face-to-face assessment of participants originally enrolled in a randomized controlled trial comparing antipsychotic maintenance versus discontinuation. Participants will undergo structured clinical interviews, cognitive testing, and psychosocial evaluations. Retrospective data from medical records on relapses, medication use, hospitalizations, and laboratory results will also be collected to analyze long-term trajectories and subgroup differences. Participants contribute by attending a single interview guided by a research assistant, answering questions about their background, symptoms, functioning, cognition, and psychological health. Researchers will measure long-term clinical outcomes, cognitive abilities, symptom severity, medication adherence, and quality of life. Data confidentiality and ethical standards are maintained throughout the study, which spans up to 20 years from original enrollment.

Researchers are evaluating the bioequivalence of a test formulation of paliperidone palmitate injection 3M produced by CSPC Zhongnuo Pharmaceutical and the reference formulation Invega Trinza by Janssen Pharmaceutica in patients with schizophrenia. The study is randomized, open-label, and conducted in multiple centers in China to compare these two long-acting injectable drugs under multiple-dose administration. Participants will receive either the test drug or the reference drug, both given as intramuscular injections of 350 mg every three months. The study uses a parallel design with multiple doses to assess how similarly the two formulations behave in the body over time. During the study, patients will be monitored up to day 456 for maximum drug concentration Cmax,ss and total drug exposure AUC,ss. Safety is evaluated by tracking the incidence and severity of adverse events. Patients will visit the study centers regularly for assessments, and their adherence and clinical status will be closely observed throughout the trial.

Researchers are evaluating culturally-adapted cognitive-behavioural therapy CBT for psychosis among Black Sub-Saharan African and Caribbean people experiencing psychosis. This case series study aims to determine if this adapted therapy is practical, acceptable, and safe for this group. The study focuses on people diagnosed with schizophrenia spectrum disorders or those receiving or having received early intervention for psychosis. Participants will attend up to 16 therapy sessions using a dedicated treatment manual designed for cultural relevance. During the study, they will complete questionnaires before and after therapy to assess changes and recovery progress. Additionally, participants will take part in a semi-structured interview to discuss their expectations and experiences with the therapy. Throughout the 16-week therapy period, researchers will monitor acceptability through interviews and evaluate therapeutic alliance, adverse events, psychosis experiences, recovery processes, and symptoms of depression, anxiety, and stress. Participants will be asked to answer questionnaires and interviews to help understand the therapys impact and safety. The entire study is expected to be completed by December 2026.

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.

Researchers are evaluating different schedules for adjusting the dose of olanzapine in patients diagnosed with schizophrenia. This Phase 2 clinical trial aims to study how safe and effective a gradual dose increase is compared to a conventional dosing schedule. The study focuses on patients who may benefit from starting with a lower dose of olanzapine based on their medical condition and have had schizophrenia for over one year. Participants are randomly assigned to one of two groups a gradual titration group or a conventional titration group. Both groups take the investigational products, labeled BR5402A through BR5402D and their variants, once daily. The study is double-blind and conducted at multiple centers, ensuring neither participants nor researchers know the assigned group during the trial. Participants will be monitored over 11 weeks, with evaluations at weeks 1, 2, 3, 5, and 9 to measure changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale PANSS. Researchers will also track any adverse effects emerging from the treatment during the study period. The trial started in May 2025 and is expected to end in May 2027.

Researchers are exploring how a digital life story application can support person-centred care for older adults with dementia. The study focuses on healthcare professionals perspectives and aims to see if the digital application can replace traditional written life story documents used in care. The life story tool is intended to help create security and improve communication between healthcare professionals and people with dementia by sharing important personal information and experiences. The study involves healthcare professionals who currently use a written life story in their daily care routines. They will participate in focus group interviews to share their experiences, then transfer information from the written life story to the digital application called Min Memoria. This digital tool will be tested in daily care settings, and researchers will observe how it is used during interactions and communication with older adults with dementia. Participants will be involved over several periods from October 2023 to August 2024, researchers will collect experiences of using the written life story from September 2024 to August 2025, usage data of the digital tool will be gathered and from September 2025 to December 2026, observations will be made on how the digital life story is used in care situations. The study will monitor these experiences and interactions to evaluate the potential benefits and application of the digital life story tool.