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Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related biomarkers will be assessed before and after the rTMS administration.
This is a hybrid1, effectiveness-implementation study of yoga-based exercises (YE) as an adjunctive tool for rehabilitation among persons with Severe Mental Illness (SMI). The two-arm randomized controlled trial will compare the efficacy of YE compared to the Wellness Lifestyle Program (WLP). Primary outcomes of the study will be self-report and performance-based measures of community functioning, defined in the investigators study as social, leisure, employment, and life skills functioning in the community. Secondary outcomes will include cognition and physical fitness measures.
This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.
The purpose of this study is to evaluate the effectiveness of a psychosocial intervention called iTEST for people with psychotic disorders that targets introspective accuracy, or the ability to accurately gauge ones abilities. iTEST combines daily cognitive training on a mobile device with coaching that addresses recovery goals. In this trial, we will randomize people to one of two interventions conditions, iTEST or a control condition that receives coaching and cognitive training that does not emphasize introspective accuracy. Both interventions will take place over 12 weeks and participants will be asked to complete assessments at baseline, 6 weeks, 12 weeks, and 24 weeks. The primary outcome of the study is community functioning. Participants will be from three metropolitan areas: San Diego, Dallas, or Miami.
The goal of this study is to reduce Anticholinergic Medication (ACM) in persons with psychoses or serious mental illness, when these medications are no longer needed.
The goal of this clinical trial is to learn if attention and ways of thinking impact decision-making and brain processes related to decision-making in people with schizophrenia or schizoaffective disorder relative to people without either condition. It will also learn how brain functioning during decision-making relates to real-world decisions made during daily life. The main questions it aims to answer are: * Does paying attention to specific information impact decision-making and brain processes? * Does thinking in a certain way according to specific 'thinking strategies' improve brain processes related to decision-making? * Does brain functioning during decision-making relate to real-world choices to engage in activities? Researchers will compare brain functioning and decision-making on computer tasks of gambling after participants have been trained to use a positive thinking strategy. They will compare what is different in the brain and behavior when participants use this strategy and when they do not. Participants will also answer brief surveys about activities and feelings for a week in their daily lives. Participants will: * Complete several hours of clinical interviewing, cognitive tests, and surveys of about symptoms, experiences, and personality * Complete computer tasks about gambling decisions during MRI brain scanning and while having their visual attention measured using eye-tracking * Complete brief surveys about their activities and feelings 5 times a day for 1 week using a cell phone. Each survey only take several minutes.
This is a single site trial in 30 patients with schizophrenia, schizoaffective, or bipolar I/II/NOS disorder in which all participants will receive eight weeks of olanzapine and samidorphan (Olz/Sam) plus four weeks of aerobic exercise.
The Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.
This study addresses the critical need for innovative therapeutic interventions in Veterans with serious mental illnesses (SMI) receiving care in VA Psychosocial Rehabilitation and Recovery Centers (PRRCs). The vast majority of individuals with SMI suffer from cognitive impairments, leading to chronic functional disability, and impaired outcomes, causing a significant strain on support networks and the VA healthcare system. This study aims to introduce an innovative mental health therapy, Targeted Cognitive Training (TCT), to Veterans struggling with serious mental illnesses (SMI). TCT works to improve basic sensory information processing and, ultimately, clinical, cognitive, and psychosocial functioning. By using EEG biomarkers to identify Veterans with SMI receiving care within VA Psychosocial Rehabilitation and Recovery Centers who are most likely to benefit from this treatment, and by understanding how best to implement this therapy, the investigators hope to enhance care and improve life quality for Veterans with SMI.