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Schizophrenia clinical trials at UC Health

27 in progress, 18 open to eligible people

Showing trials for
  • A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

    open to eligible people ages 18-65

    A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 40 locations world wide. The study will last up to nine (9) weeks.

    at UCSD

  • A Neurofeedback Intervention 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

  • A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia

    open to eligible people ages 18-70

    Schizophrenia has a devastating and disproportionate effect on veterans compared to the general US population. Some of the most disabling symptoms, such as low motivation, difficulty expressing emotions, and decreased ability to infer the mental states of others, cause poor social functioning. This means that veterans with schizophrenia have trouble navigating interpersonal interactions and building meaningful relationships in the community. Unfortunately, current antipsychotic medications typically only improve positive symptoms but fail to improve social functioning deficits, which are strong predictors of poor quality of life and functional outcomes. Oxytocin, a peptide found in the brain, plays an important role in social behavior and is known to moderate affiliation, stress, and learning across taxa. In this study, the investigators will test whether oxytocin could be an effective treatment for social functioning deficits in schizophrenia. The investigators will examine changes in brain activation to understand how oxytocin affects behavior and to predict which individuals may benefit from oxytocin treatment.

    at UCLA UCSF

  • A Study of the Effects of Brain Stimulation on Higher-Order Cognition

    open to eligible people ages 18-35

    The purpose of this study is to better understand the neural correlates of higher-order cognition, both in the healthy brain and in schizophrenia, and to determine how these mechanisms are modulated by transcranial direct current stimulation (tDCS) at frontal and occipital scalp sites. Testing the effects of tDCS at these scalp sites on cognitive task performance will help us understand the roles of the brain regions corresponding to these sites during higher-order cognitive processing (language comprehension, cognitive control, and related attention and memory processes). Behavioral and electrophysiological (EEG) measures will be used to assess cognitive performance. The investigator's overarching hypothesis is that stimulating prefrontal circuits with tDCS can improve cognitive control performance, and ultimately performance on a range of cognitive tasks, as compared to stimulating a different cortical region (occipital cortex) or using sham stimulation. This study is solely intended as basic research in order to understand brain function in healthy individuals and individuals with schizophrenia. This study is not intended to diagnose, cure or treat schizophrenia or any other disease.

    at UC Davis

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

    open to eligible people ages 18-64

    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

  • Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

    open to eligible people ages 18-45

    This 12-month study will evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia.

    at UCLA

  • Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

    open to eligible people ages 18-64

    1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 mg/d compared with placebo in prevention of relapse in patients with schizophrenia 2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d

    at UCSD

  • Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM)

    open to eligible people ages 18-60

    Primary study: This study is a single-site, double-blind, randomized, controlled clinical trial to compare an evidence-based structured program of 30-35 hours of on-line cognitive and social cognitive training exercises performed over 16 weeks (~2 hours per week), delivered with an innovative digital app which provides users with a motivation coach to set personalized goals and with secure social networking for peer support, "PRIME" ; vs. 2) A control condition of computer games, encouraged at ~2 hours per week over 16 weeks, delivered with "PRIME". Unblinded Cognitive Training Sub-Study: Participants who were randomized to the computer games arm of the trial may be offered access to the active cognitive training at the end of their 6 month follow up appointments, if they still meet inclusion criteria. PRIME Super Users Sub-Study: Participants who have provided all follow up data to the initial study, including those who are currently enrolled in the Unblinded Cognitive Training sub-study, may be offered continued participation in the PRIME community as super-users.

    at UCSF

  • Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in Schizophrenia

    open to eligible people ages 18-35

    The purpose of this study is to use a non-invasive brain stimulation technique, transcranial direct current stimulation (tDCS), to test a set of hypotheses about the role of the prefrontal cortex in behavioral and neural correlates of cognition in schizophrenia. Behavioral, electrophysiological (EEG) and neuroimaging measures will be used to assess cognitive performance. This study has three main goals: (1) To compare the effects of task-engaged versus resting tDCS in order to optimize the impact of tDCS on goal maintenance related neural oscillatory activity and task performance in schizophrenia; (2) To establish the regional specificity of the impact of DLPFC tDCS (compared to Occipital tDCS) effects on brain circuitry underlying goal maintenance in schizophrenia; (3) To examine relationships between tDCS effects on DLPFC GABA levels, DLPFC-related oscillatory activity and cognitive performance in schizophrenia. This study is solely intended as basic research in order to understand brain function in healthy individuals and individuals with schizophrenia. This study is not intended to diagnose, cure or treat schizophrenia or any other disease.

    at UC Davis

  • 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

  • Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia

    open to eligible people ages 18-50

    This application seeks to determine if neurophysiological metrics of memantine (MEM)-enhanced early auditory information processing (EAIP) in schizophrenia (SZ) mediate gains in auditory processing fidelity (APF) and auditory learning.

    at UCSD

  • Mobile CBT for Negative Symptoms

    open to eligible people ages 18-60

    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

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

    open to eligible people ages 18-65

    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

  • Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness

    open to eligible people ages 18-70

    Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its standard dose and titration schedule (half of the participants) versus b) at a lower dose and slower titration schedule (the other half), for 12 weeks. All smokers will choose a target quit date sometime between 8 to 35 days after starting the medication. All participants will receive ten 30-minute sessions of a behavioral treatment called Acceptance and Commitment Therapy (ACT). Participants will be followed for an additional 12 weeks off study medication. The major endpoint is the feasibility of combining ACT with the different dosing strategies. Investigators will also conduct a blood test that measures the breakdown of nicotine in the body to explore whether that measure influences treatment response and side effects.

    at UCSD

  • Pharmacologic Augmentation of Targeted Cognitive Training in Schizophrenia

    open to eligible people ages 18-55

    These studies look to conduct efficient pilot testing of a novel intervention strategy for chronic psychotic disorders - Pharmacologic Augmentation of Cognitive Therapy (PACT) - via an experimental medicine approach. Antipsychotics are the major therapeutic tool for chronic psychotic disorders, including schizophrenia, but do not significantly alter their course or real-life impact. Specific cognitive therapies achieve modest symptom reduction and improved function and cognition in psychosis patients, including "bottom-up" sensory-based targeted cognitive training (TCT). While benefits of TCT are evident at the group level, almost half of all patients demonstrate little or no cognitive gains after 30-40 hours (h) of TCT. For patients and clinicians, the costs and logistical complexities associated with these time- and resource-intensive interventions can be prohibitive. We propose and will test a novel "augmentation strategy" for using medications to specifically enhance the benefits of TCT in schizophrenia.

    at UCSD

  • Target Engagement and Response to Oxytocin

    open to eligible people ages 18-65

    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

  • 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

  • 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

  • Adapting and Examining Collaborative Decision Skills Training Among Veterans With Serious Mental Illness

    Sorry, not yet accepting patients

    Recovery-oriented care is an imperative for the VA, particularly in mental health programming for Veterans with serious mental illness (SMI). Collaborative decision-making (CDM) is a recovery-oriented approach to treatment decision-making that assigns equal participation and obligation to patients and providers across all aspects of decision-making, thereby empowering patients and facilitating better decision-making based on patient values and preferences. CDM is associated with several important outcomes including improved treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low, and there is not yet an evidence-based method to improve CDM. Improving Veteran skill sets associated with engaging in CDM is a potential intervention strategy. Collaborative Decision Skills Training (CDST) is a promising new intervention that was previously developed by the applicant for use in adult civilians with SMI and found to improve relevant skills and improve sense of personal recovery. The proposed study has two primary stages. First, a small, one-armed, open label trial will establish CDST's feasibility will evaluate CDST among 12 Veterans with SMI receiving services at the VA San Diego Psychosocial Rehabilitation and Recovery Center (PRRC) and identify and complete any needed adaptations to CDST. Stakeholder feedback from Veterans, VA clinicians, and VA administrators will be collected to assess Veteran needs and service context to identify any needed adaptations to the CDST manual or the delivery of CDST to maximize its impact and feasibility. The developers of CDST will review all feedback and make final decisions about adaptations to ensure that CDST retains its essential components to protect against loss of efficacy. For example, a recommendation to adjust role-play topics to better reflect the needs of Veterans would be accepted because it would increase CDST's relevance without impairing its integrity, but a recommendation to remove all role-plays would not be accepted because it would cause loss of a key component. Second, CDST will be compared to active control (AC) using a randomized clinical trial of 72 Veterans. The primary outcome measure will be functioning within the rehabilitation context, operationalized as frequency of Veteran CDM behaviors during Veteran-provider interactions. Secondary outcomes are treatment attendance, engagement, satisfaction, and motivation, along with treatment outcomes (i.e., rehabilitation goal attainment, sense of personal recovery, symptom severity, and social functioning). Three exploratory outcomes will be assessed: Veteran-initiated collaborative behaviors, acute service use and provider attitudes and behavior. Veterans will be randomly assigned to CDST or AC conditions. Veterans in the both groups will attend eight hour-long group sessions held over eight weeks. All Veterans will complete an assessment battery at baseline, post-intervention, and at three-month post-intervention follow-up. Following the trial and adaptation phase, the findings will be used to develop a CDST service delivery manual and design a logical subsequent study. The results of the proposed study will inform the potential for larger trials of CDST and the utility of providing CDST broadly to Veterans with SMI. The results of this study will expand current understanding of CDM among Veterans with SMI by providing data that will: 1) identify adaptations needed to optimize CDST for Veterans receiving services in PRRCs; 2) identify possible benefits of CDST; 3) inform development of alternate interventions or methods to improve CDM; and 4) further elucidate CDM and associated treatment processes among Veterans with SMI receiving VA rehabilitation services.

    at UCSD

  • Compensatory Cognitive Training in Clinical High Risk Latino Youth

    Sorry, in progress, not accepting new patients

    This is a randomized study to compare Compensatory Cognitive Training (CCT) versus Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico. Study hypotheses: Compared to those who receive RT, study participants receiving CCT will show significant improvement in neurocognition, functional capacity, self-rated functioning and clinical measures.

    at UCSD

  • 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

  • Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis

    Sorry, not yet accepting patients

    A large proportion of people with a schizophrenia-spectrum disorder, especially in the early stages of the disease, regularly consume cannabis. Cannabis use is associated with poor prognostic outcome; however, there are no effective interventions targeted at reducing cannabis use or its deleterious effects in this population. The present trial is designed to test whether cannabidiol (CBD), a cannabinoid whose effects are in many ways antagonistic to those of Δ9-tetrahydrocannabinol (THC), can reduce psychiatric symptoms, cognitive deficits, and cannabis use in people with recent-onset psychosis who regularly consume cannabis.

    at UCLA

  • Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial

    Sorry, not yet accepting patients

    The present study is a confirmatory efficacy trial of Family Focused Therapy for youth at clinical high risk for psychosis (FFT-CHR). This trial is sponsored by seven mature CHR clinical research programs from the North American Prodrome Longitudinal Study (NAPLS). The young clinical high risk sample (N = 220 youth ages 13-25) is to be followed at 6-month intervals for 18 months.

    at UCLA

  • Optimizing Cognitive Remediation

    Sorry, not yet accepting patients

    Veterans with mental illness face challenges with community reintegration, including achieving vocational success, attaining their educational goals and going back to school, and maintaining a high quality of life. VA Mental Health Residential Rehabilitation Treatment Programs and Psychosocial Rehabilitation and Recovery Centers are designed to help Veterans overcome these barriers, but cognitive impairment often seen in Veterans with mental illness limits gains from these settings. Cognitive remediation interventions can be helpful, but they are either "one-size fits all," and thus may not be useful for all Veterans with mental illness, or are too narrow in scope, focusing on specific mental illnesses, limiting generalizability. This project will test whether an objective neurophysiological biomarker, mismatch negativity (MMN), can better match the "right" Veteran to the "right" cognitive remediation treatment regardless of their specific mental health diagnosis.

    at UCSD

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

    Sorry, in progress, not accepting new patients

    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

  • 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

    Sorry, in progress, not accepting new patients

    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

  • Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants With Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment

    Sorry, not currently recruiting here

    This study will be conducted to evaluate the efficacy, safety, and tolerability of GWP42003-P versus placebo in participants with schizophrenia experiencing inadequate response to ongoing antipsychotic treatment.

    at UCLA

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