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Schizophrenia clinical trials at UC Health
29 in progress, 15 open to new patients

  • "Cognitive Training Delivered Remotely to Individuals With Psychosis

    open to eligible people ages 18-60

    The purpose of this study is to use remote methods and scalable interactive neurotechnology to generate important data on the potential for remote targeted cognitive treatment in people with schizophrenia. The investigators will perform a double-blind randomized control trial in 120 participants with schizophrenia, comparing: 1) An evidence-based structured program of 40 hours of on-line auditory and social cognitive training (exercises over 12 weeks (-3.5 hours per week), delivered with an innovative digital application which provides users with a motivation coach to set personalized goals and with secure social networking for peer support, Personalized Real-time Intervention for Motivational Enhancement (PRIME) ; vs.2) A control condition of free-choice on-line cognitive exercises, encouraged at 3.5 hours per week over 12 weeks, delivered with a standard commercial goal-setting app, "Daily Goals".

    at UCSF

  • Adult Study Oxytocin - Behavioral

    open to eligible males ages 18-45

    In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders. Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia. Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo. Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.

    at UCSF

  • Biomarker Strategies for Medication-Enhanced Cognitive Training in Schizophrenia

    open to eligible people ages 18-55

    Cognitive training is moderately effective at reducing symptoms and improving life function in schizophrenia patients. The present application develops a strategy for increasing the effectiveness of cognitive training through the use of pro-cognitive medications. Specific biomarkers will be studied that identify patients most sensitive to these pro-cognitive medications, to test the feasibility of using these biomarkers in a large clinical trial of medication-enhanced cognitive training in schizophrenia.

    at UCSD

  • Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia

    open to eligible people ages 18 years and up

    This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)

    at UCSD

  • Emotional Response in Psychiatric and Control Participants

    open to eligible people ages 18-65

    The purpose of this research is to understand how the emotions of people with different mental health concerns (e.g., people with schizophrenia, people with major depressive disorder) differ from individuals without mental health concerns. A large body of literature suggests that people with mental illnesses have emotional abnormalities compared to healthy individuals, but a number of these abnormalities are not well understood. For example, often people with schizophrenia report on questionnaires that they experience fewer pleasant emotions when talking with other people, but some evidence suggests these individuals report a similar amount of pleasant emotion when they are actually engaged in a pleasant activity. Thus, it is unclear the extent to which reports of emotional abnormalities extend to a more real-world setting. In the tasks in the current proposal, participants will engage in a series of tasks designed to assess their emotional functioning. These tasks involve viewing emotional stimuli on the computer, engaging in social interactions, and consuming small amounts of food. In all tasks, participants will make ratings of their experiences of pleasure (and displeasure). We will then compare the experiences of patient groups to those of healthy individuals to test how emotional ratings might differ across these tasks.

    at UC Irvine

  • Enhancing Cognitive Training Through Exercise Following a First Schizophrenia Episode

    open to eligible people ages 18-45

    This is a confirmatory randomized controlled trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. Treatment occurs for 6 months after randomization, with a followup assessment at 12 months. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce neurotrophin increases and cognitive and functional improvements, even relative to cognitive training alone. The investigators target the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to functional outcome, before chronic disability is established.

    at UCLA

  • Ford Rumination and Mindfulness Merit

    open to eligible people ages 18-65

    The investigators will acquire simultaneous EEG and fMRI data from veterans with depression and schizophrenia and mentally healthy veterans to assess early sensory responses, context updating, and responses to emotional images. Understanding how rumination affects engagement with the environment is the first step towards assessing its far-reaching cognitive and emotional costs, which cut across traditional diagnostic boundaries. Understanding how mindfulness restores information processing will increase our understanding of how, and for whom, it works.

    at UCSF

  • Neurofeedback to Improve Working Memory in Schizophrenia

    open to eligible people ages 18-65

    Schizophrenia affects 2.4 million Americans and causes significant individual and societal costs. Cognitive deficits including poor working memory arise early in the course of illness, account for poor long-term outcomes and have been difficult to treat with available treatments. The investigators are proposing to develop a novel, computer-based brain training to improve working memory in schizophrenia patients, which, if successful could have significant personal, societal, and economic impact.

    at UCSD

  • Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia

    open to eligible people ages 18-45

    This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode schizophrenia.

    at UCLA

  • Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

    open to eligible people ages up to 21 years

    Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

    at UCSD UCLA

  • Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia.

    open to eligible people ages 18-55

    This application seeks renewed support for MH59803, "Dopaminergic substrates of startle gating across species," to extend a clear path of "bench-to-bedside" progress towards a critical paradigm shift in therapeutic models for schizophrenia (SZ) and schizoaffective disorder, depressed type (SZA): the use of Pharmacologic Augmentation of Cognitive Therapies (PACTs). This novel therapeutic strategy for SZ/SZA directly addresses the need for more effective treatments for this devastating disorder. MH59803 has investigated the neural regulation of laboratory-based measures of deficient information processing in SZ/SZA patients, using rodents and healthy human subjects (HS) to explicate the biology of these deficits, and to establish a rational basis for developing novel therapies for SZ/SZA. In its first 9 years, MH59803 studies of the neural regulation of prepulse inhibition (PPI) of startle in rats focused on basic neurobiological and molecular mechanisms. Over the past 2 years of support, MH59803 studies moved "from bench-to-bedside," focusing on dopamine (DA) agonist effects on PPI and neurocognition in HS, and their regulation by genes identified in cross-species studies. These studies detected biological markers that predict PPI-enhancing and pro-cognitive effects of the DA releaser, amphetamine (AMPH) in humans, leading to specific predictions of AMPH effects on PPI, neurocognition and Targeted Cognitive Training in SZ/SZA patients. If confirmed in the present application, these predictions could help transform therapeutic approaches to SZ/SZA. This renewal application of MH59803 thus reflects a logical progression of studies at systems and molecular levels, translated first to HS, and now to potentially transformative therapeutic models in SZ/SZA patients.

    at UCSD

  • Reward Processing in Mental Illness

    open to eligible people ages 18-30

    The purpose of this study is to examine the nature of reward processing dysfunctions in schizophrenia using neuroimaging techniques that capture in vivo brain functioning, such as EEG and fMRI.

    at UCSF

  • The Effects of Transcranial Direct Current Stimulation (tDCS) on the Neuronal Mechanisms of Cognitive Control in Schizophrenia

    “Help us develop new treatments for patients who have difficulty with brain functions such as reasoning, including schizophrenic patients”

    open to eligible people ages 18-35

    The purpose of this study is to better understand the neural correlates of cognitive control (CC) deficits in schizophrenia and determine how these mechanisms can be modulated by transcranial direct current stimulation (tDCS). CC is a critical neurocognitive process that is required for flexible, directed thought and action based on goals and intentions. Identifying and developing paradigms to improve CC is therefore a mental health priority. Current theories of CC postulate that recruitment of the dorsolateral prefrontal cortex (DLPFC) is essential for this process by maintaining high-level information that it can then use to orchestrate patterns of activation in other brain networks to support optimal performance. tDCS is a safe, noninvasive method of modulating regional brain excitability via brief (15-20 m) application of a weak (1-2 mA) current. The goal of the proposed experiments is to combine tDCS with functional magnetic resonance imaging (fMRI) to test the hypotheses that 1) acute tDCS over the DLPFC can improve performance during a CC task (the dot pattern expectancy (DPX) variant of the AX-Continuous Performance Task) in schizophrenia patients and healthy control subjects, and 2) acute tDCS over the DLPFC can increase recruitment of the DLPFC during the DPX. Effects of tDCS on brain functional connectivity (during CC as well as during the resting state) will also be examined, as well as effects on an episodic memory task. The current study will be the first to use functional magnetic resonance imaging (fMRI) to examine the effects of tDCS on the neuronal mechanisms of CC in schizophrenia, and has potentially important implications for therapeutic development for this treatment refractory yet disabling aspect of the illness.

    at UC Davis

  • This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months

    open to eligible people ages 18-55

    The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.

    at UCLA

  • Treatment of Cognitive and Negative Symptoms in Schizophrenia With N-acetylcysteine

    open to eligible people ages 18-65

    The purpose of this study is to attempt to treat cognitive and negative symptoms of schizophrenia, with the nutritional supplement N-acetylcysteine (NAC). Schizophrenia is a chronic mental disorder that affects approximately 65 million people worldwide, and causes significant disability and suffering. Patients with schizophrenia often hear voices and have persecutory delusions. Though these are the most recognizable features of the illness, the deficits most closely linked to disability are known as cognitive deficits and negative symptoms. Cognitive abilities refer to the ability to perform mental tasks that require focus and attention, and also include memory and verbal skills. Negative symptoms refer to a lack of interest in the world, and decreased social interactions. In our study, the investigators aim to improve these symptoms and deficits by targeting the glutamate system. Glutamate is the major excitatory neurotransmitter in the brain, and its regulation is abnormal in schizophrenia: glutamate levels are too low at some receptors, and too high at others. As well, free radicals surrounding glutamate receptors also interfere with their proper function. N-acetylcystine (NAC) is a safe and widely-available dietary supplement that may restore glutamate to its correct levels in the brain, and may also help protect the brain from antioxidant damage. In our study, patients with schizophrenia will be randomly assigned to receive either NAC or placebo for 8 weeks. Brain levels of glutamate and an important antioxidant, glutathione, will be measured before and after treatment, using a neuroimaging technique known as magnetic resonance spectroscopy. Cognitive and negative symptoms will also be assessed before, during and after treatment. The investigators hypothesize that glutamate and glutathione will be normalized in patients' brains, and that their negative and cognitive symptoms will be improved, too.

    at UCLA

  • A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia

    Sorry, in progress, not accepting new patients

    The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working (composite score of the Spatial Span and Letter Number Span tests) memory in individuals who are HSV-1 positive and early in the course of schizophrenia. We hypothesize that individuals who are HSV-1 positive, but not those who are HSV-1 negative, will demonstrate significant valacyclovir efficacy for visual and working memory.

    at UCLA

  • Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia

    Sorry, not yet accepting patients

    To determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total score) in persons with schizophrenia. A secondary aim is to determine whether WSE reduces measures of positive and negative symptoms (PANSS subscales) and stress scores on the Perceived Stress Scale (PSS).

    at UCLA

  • Antipsychotic Effects of Oxytocin

    Sorry, currently not accepting new patients, but might later

    The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.

    at UCSD UC Irvine

  • Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI

    Sorry, accepting new patients by invitation only

    Schizophrenia and bipolar disorder are associated with high risk for suicide, yet there are few brief interventions that directly target suicide prevention in this large population. The goal of this intervention development study is to evaluate the feasibility, acceptability, and preliminary effectiveness of a brief intervention called SafeTy and Recovery Therapy (START) that is augmented with content delivered on mobile devices outside of the clinic setting. The intervention will evaluated in a community urgent care center context as people initiate outpatient care, and, if effective, could be deployed in a wide network of such centers.

    at UCSD

  • Mobile CBT for Negative Symptoms

    Sorry, not yet accepting patients

    This randomized controlled clinical trial will test a combined group contact plus mobile CBT-informed skills training intervention targeting defeatist attitudes in consumers with schizophrenia in comparison to a supportive contact control group in order to change motivational negative symptoms linked to defeatist attitudes.

    at UCSD

  • Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia

    Sorry, in progress, not accepting new patients

    This clinical trial will test a combined group therapy plus mobile cognitive behavioral therapy intervention targeting defeatist attitudes in consumers with schizophrenia in order to change motivational negative symptoms linked to defeatist attitudes.

    at UCSD

  • Multi-component Intervention for Diabetes in Adults With Serious Mental Illness

    Sorry, in progress, not accepting new patients

    Persons with schizophrenia and other serious mental illnesses have a high risk for type 2 diabetes and an increased risk of premature mortality compared to the general population. The goals of the proposed study are to implement a multimodal lifestyle intervention to reduce that risk in these individuals living in residential care facilities, a common housing modality for people with serious mental illnesses. If successful, this intervention will lead to reduction in excess medical comorbidity and mortality in persons with serious mental illnesses.

    at UCSD

  • My Coach Connect: An Automated Telephone-based Reporting System for Patients With Mental Illness

    Sorry, in progress, not accepting new patients

    This is a pilot study for a novel, automated telephone system called "My Coach Connect". The purpose of the study is to evaluate the feasibility and effectiveness of this telephone tool while engaging clients and providers in discussion groups and surveys to better understand how this tool impacts the care provided and their overall experience in healthcare.

    at UCLA

  • Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia

    Sorry, currently not accepting new patients, but might later

    The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute being on adequate treatment with antipsychotic medication.

    at UCSD

  • Oxytocin Add on Study for Stable Schizophrenic Patients

    Sorry, currently not accepting new patients, but might later

    The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.

    at UCSD

  • PACT for Individuals With Serious Mental Illness

    Sorry, in progress, not accepting new patients

    People with serious mental illness have difficulty making good use of primary care, and die, on average, years earlier than others in the population. The greatest contributors to this premature mortality are medical illnesses, especially cardiovascular disease and cancer. The Patient Centered Medical Home is a model for reorganizing primary care practice so that healthcare is more effective, efficient, and user-friendly. It has been implemented across VA as the, "Patient Aligned Care Team" (PACT). It is unclear, however, how this PACT model applies to people whose predominant illness is treated by specialists. This is the case for people with serious mental illness (SMI), many of whom receive ongoing treatment at mental health clinics. To achieve optimal health outcomes in the population with SMI, it may be necessary to adapt the PACT model so that it includes approaches that have proven to improve healthcare in this population. This project implements an adapted "SMI-PACT" model, and evaluates its effect on Veterans with SMI.

    at UCSD

  • Pediatric Open-Label Extension Study

    Sorry, in progress, not accepting new patients

    This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326

    at UCSF

  • Project Bridge: Peer Health Navigator Intervention

    Sorry, in progress, not accepting new patients

    The mortality rate among people with Serious Mental Illness (SMI) is 2 to 3 times that of the general population, meaning that those with a serious mental illness die, on average, 25 years earlier than those without an SMI. These deaths are largely attributed to preventable medical conditions, many of which are more common in the SMI population. The "Bridge" intervention is a peer navigator model that was developed to target factors that negatively impact healthcare access, utilization, and outcomes among individuals with serious mental illness (e.g., severe mood disorders and psychotic disorders). This intervention targets male and female, adult consumers across races/ethnicities and has been utilized by Pacific Clinics (Southern California's largest behavioral healthcare agency) and the Department of Mental Health of Los Angeles County to improve the health and quality of life for their consumers. Investigators will test the comparative effectiveness of a peer navigator intervention (the Bridge) to treatment as usual. The Bridge navigator intervention is designed to teach SMI consumers the skills to engage health care providers and to overcome motivational deficits in order to improve their health and healthcare use. The specific aims of this application are: 1. To use randomized methods to examine the effectiveness of the Bridge intervention on the health care utilization, satisfaction with care, health status, and health care self-management for a sample of individuals with severe mental illness receiving public mental health services in the community; 2. To use randomized methods to examine the effectiveness of the Bridge intervention on psychological and social well-being for a sample of individuals with severe mental illness receiving public mental health services in the community. Up to 146 participants in an Full Service Partnership (FSP) clinic operated by Pacific Clinics will be recruited to participate in an approximately 24 month long study of Bridge navigation. Participants will be randomly assigned to either treatment as usual (waitlist) or immediate intervention with the Bridge. Participants in both groups will complete three assessments (baseline, 6 months, 12 months) and statistically compared over time. Staff stakeholders (n = 20) will also be interviewed at baseline and every three months of the study in order to ensure that the intervention is being implemented appropriately.

    at UCLA

  • Target Engagement and Response to Oxytocin

    Sorry, not yet accepting patients

    This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.

    at UCLA

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