Schizophrenia

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 paradigm's implementation and cost-effectiveness, focusing on populations facing health disparities. Total participation duration varies by patient and clinic schedule.

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 (AUCτ,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 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.

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 the safety of a drug called SEP-363856 in adults diagnosed with schizophrenia. The study aims to understand how well patients tolerate the medication when taken daily for up to 52 weeks. This research is a phase 3 trial led by Otsuka Pharmaceutical Co., Ltd., focusing on long-term treatment effects in clinically stable individuals with this condition. Participants will take SEP-363856 tablets once daily, starting with 50 mg per day for the first three days, increasing to 75 mg per day for days four to seven. From day eight onwards, the dose will typically be 100 mg per day unless there are concerns about tolerability, in which case the dose may be adjusted to 75 mg. The study does not include a comparison group and all participants receive the investigational medication. During the 52-week treatment period, researchers will monitor participants closely for any adverse events and measure how often these treatment-emergent side effects occur. Participants will have regular assessments to ensure clinical stability, including evaluations of symptoms and medication adherence. The study provides ongoing safety monitoring throughout the year-long participation.

Researchers are conducting a 52-week open-label study to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in adults with schizophrenia. This study includes participants who have recently completed a prior study (ML-007C-MA-211) as well as new participants enrolling directly. The goal is to better understand how ML-007C-MA performs over an extended period in managing schizophrenia symptoms. Participants will receive ML-007C-MA dosed as 210/3 mg twice daily throughout the 52-week treatment period. The study is designed as an open-label trial, meaning both researchers and participants know the treatment being administered. No placebo or comparator groups are involved in this phase 2 research. During the study, participants will undergo assessments to monitor safety and tolerability from the initial dose through the end of treatment. Researchers will also evaluate the effectiveness of ML-007C-MA in managing schizophrenia symptoms. The study involves outpatient care, regular clinical interviews, and the involvement of reliable informants to support assessments. Participants will be observed for up to one year to gather comprehensive data on long-term treatment outcomes.