Active clinical trials for "Schizophrenia"

Background: In parallel to the traditional symptomatology, deficits in cognition (memory, attention, reasoning, social functioning) contribute significantly to disability and suffering in individuals with schizophrenia. Cognitive deficits have been closely linked to alterations in early auditory processes (EAP) that occur in auditory cortical areas. Preliminary evidence indicates that cognitive deficits in schizophrenia can be improved with a reliable and safe non-invasive brain stimulation technique called tDCS (transcranial Direct Current Stimulation). However, a significant proportion of patients derive no cognitive benefits after tDCS treatment. Further, the neurobiological mechanisms of cognitive changes after tDCS have been poorly explored in trials and are thus still unclear. Method: The study is designed as a randomized, double-blind, 2-arm parallel-group, sham controlled, 4-centers trial. Sixty participants with recent-onset schizophrenia and cognitive impairment will be randomly allocated to receive either active (n=30) or sham (n=30) tDCS (20-min, 2-mA, 10 sessions during 5 consecutive weekdays). The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left auditory cortex. Cognition, tolerance, symptoms, general outcome and EAP (measured with EEG and multimodal MRI) will be assessed prior to tDCS (baseline), after the 10 sessions, and at 1- and 3-month follow-up. The primary outcome will be the number of responders, defined as participants demonstrating a cognitive improvement ≥Z=0.5 from baseline on the MATRICS Consensus Cognitive Battery total score at 1-month follow-up. Additionally, we will measure how differences in EAP modulate individual cognitive benefits from active tDCS and whether there are changes in EAP measures in responders after active tDCS. Discussion: Besides proposing a new fronto-temporal tDCS protocol by targeting the auditory cortical areas, we aim to conduct an RCT with follow-up assessments up to 3-months and a large sample size. In addition, this study will allow identifying and assessing the value of a wide range of neurobiological EAP measures for predicting and explaining cognitive deficits improvement after tDCS. The results of this trial will constitute a step toward the use of tDCS as a therapeutic tool for the treatment of cognitive impairment in recent-onset schizophrenia.

In a randomized controlled design with approximately 26 biweekly sessions over 12 months, the investigators propose to test the effectiveness of an ECHO-based intervention for improving the use of clozapine in people eligible for clozapine. The sessions will include: 1) active dissemination of knowledge and information by an expert "hub" followed by 2) clozapine case presentations and vignettes submitted by the "spokes". This intervention, Clozapine CHAMPION-ECHO (Center for Help and Assistance for Maryland Prescribers- Improving Outcomes Network using Extension for Community Healthcare Outcomes, will be referred to as "CHAMPION" throughout.. To minimize ANC monitoring barriers and maximize recruitment, the investigators will provide Food and Drug Administration (FDA)-cleared ANC point of care (POC) monitoring devices to all study sites, including those in the control condition. The investigators will enroll at least 300 prescribers and additional clinical team members (up to 300) from 60 outpatient mental health clinics (OMHCs) and other treatment sites; approximately half the OHMCs will be randomized to CHAMPION and half randomized to enhanced treatment as usual (ETAU).

This study plans to learn more about the effects of levetiracetam (LEV) on brain activity and cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an anti-seizure drug, also called an anticonvulsant.

To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

Multiple chronic conditions (MCC) are widely recognized as the U.S. public health challenge of the 21st century. These physical and behavioral health conditions take a large toll on those suffering from the diseases, including many who are publicly insured, as well as caregivers and society. While evidence-based integrated care models can improve outcomes for individuals with MCC, such models have not yet been widely implemented. Insurance providers/payers have innovative system features that can be used to deploy these models; however, the investigators do not yet know which of these features can best help to improve outcomes for individuals with MCC in general or high-need subgroups in particular. As a result, patients lack information to make important decisions about their health and health care, and system-level decision makers face ongoing challenges in effectively and efficiently supporting those with MCC. This real-world study will provide useful information about available options for supporting individuals with MCC. Building on existing integrated care efforts, the investigators will enroll N=1,927 (N=265 Phase I and N=1,662 Phase II) adults with MCC at risk for repeated hospitalizations and assess the impact of three payer-led options (e.g. High-Touch, High-Tech, Usual Care) on patient-centered outcomes, namely patient activation in health care, health status, and subsequent re-hospitalization. The investigators will also determine which option works best for whom under what circumstances by gathering information directly from individuals with MCC through self-report questionnaires, health care use data, and interviews.

Individuals with schizophrenia spectrum disorder (SSD) often face unique barriers that limit the development of long-lasting lifestyle changes. In this study, The investigators will investigate the feasibility and impact of a novel lifestyle intervention in individuals with schizophrenia or schizoaffective disorder. The intervention will be composed of group fitness instruction and educational nutrition didactics that will be accessible to participants at-home through remote streaming. The fitness component will consist of weekly group fitness sessions delivered by a certified personal trainer over a virtual interface. The educational nutritional component of this intervention will involve interactive didactic sessions designed to improve knowledge of nutrition and positively change dietary behavior in this population.

The microbiota plays a vital role in the two-way communication between the gastrointestinal tract and the central nervous system (CNS), articulated as the microbiota-intestine-brain axis. This function provides sufficient evidence to establish a causal relationship between numerous neuropsychiatric disorders, such as schizophrenia. Besides, the microbiota modulation through the dietary pattern is related to the improvement of the physical and psychopathological health of patients. In this sense, the use of psychobiotics (prebiotics and probiotics with nutraceutical action) highlights. This research will be aimed to test the efficacy of prebiotic dietary modulation in patients diagnosed with schizophrenia, attending to the impact in nutritional and cardio-metabolic conditions. In this sense, two-arms, double-blind, randomized in balanced blocks clinical trial of six months of intervention, will be developed in a group of 50 individuals (25 for the intervention group (IG) and 25 for the control group). First, an initial group session will be held to present the purpose of the research, as well as each of the relevant aspects during its development. Similarly, certain focus groups will be established periodically to redefine and guide the improvement of the development of the investigation, ensuring adequate compliance with the study after the implementation of the diet and nutrition education program. The dietary education will be designed and supervised by qualified personnel with recognized competencies for this type of intervention (nurses and dietitians). The CG will be made up of those participants who receive conventional dietary advice individually in serial consultations. On the other hand, in the IG, this intervention will be characterized by the establishment of an individual program of dietetic-nutritional education with high prebiotic and probiotic content. During the development of the study, data will be collected on the psychopathological state (PANSS and PSP scales), and blood test (hemogram, lipid profile, etc.). Measures will be taken at the beginning (basal), at three and six months. The estimation of intestinal microbiota and the usual nutritional pattern will also be assessed at the beginning and six months, using a stool test and a validated Food Frequency Questionnaire (FFQ), respectively. To evaluate the degree of adherence, participants in the IG will fill a specific weekly record of the main dishes/food consumed. At least, anthropometric parameters will also be analyzed monthly (BMI, blood pressure, heart rate, abdominal perimeter).

People with schizophrenia have low functionality and psychological resilience. Psychological resilience of individuals can be improved. The funcionality of individual with improved psychological resilience can also be improved. Therefore, both resilience and functionality can be increased by appliying resilience programs to patients with schizophrenia.

Constipation in schizophrenia is an important issue in clinical care. Constipation needs psychiatric professionals concerning and providing intervention because it may cause ileus and lead to death. The cause of constipation in patients may be due to side effects of antipsychotic medication, sedentary lifestyle, insufficient water intake, fiber, etc. The study aims to increase fiber of the consumption of psyllium to assess the constipation effectiveness in schizophrenics. The study conducted a crossover research design. G-power was used to calculate the 22 subjects in each of the two groups. A total of 44 patients with constipation who were schizophrenics will participate in the study. Patients will use simple randomly to be divided into two groups based on their live ward for pre-testing. These two groups will receive either psyllium 3.5 g/day or 7 g/day for 4 weeks in a single-blind, crossover trial. The trial will stop 1week after the first phase and post-test. Then, two groups will exchange the dose for 4 weeks. Post-test will record after finishing this second phase trial. This study can understand the benefits of psyllium on schizophrenics with constipation symptoms and can give professional suggestions to patients with constipation in the future.

The purpose of this study in patients with schizophrenia is to evaluate the safety, tolerability, and pharmacokinetics of 3 doses (low, mid, high) of APN1125 compared with placebo when administered as repeated daily oral doses.