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Psychotic Disorders clinical trials at University of California Health

22 in progress, 16 open to eligible people

Showing trials for
  • Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness

    open to eligible people ages 18 years and up

    Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.

    at UCSD

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

    open to eligible people ages 18 years and up

    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

  • Determining the Role of Social Reward Learning in Social Anhedonia

    open to eligible people ages 18-35

    This is a clinical trial study that aims to evaluate the specificity of the relationship between reduced sensitivity to social reward and social anhedonia at both behavioral and neural levels. Individuals who recently experienced their first-episode psychosis will be recruited. Participants will be randomized 1:1 to motivational interviewing or a time- and format-matched control probe. At pre- and post-probe, participants will perform two social reward learning tasks in the scanner. With this design feature, we will examine the relationship between sensitivity to social reward and reduced subjective experience of social pleasure at both the behavioral and neural levels.

    at UCLA

  • Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis

    open to eligible people ages 16-30

    This is an outpatient, single center, between-group, double blind, placebo controlled design. Approximately 120 adolescents and adult patients will be randomized to either have their treatment augmented with Cannabidiol Oral Solution (CBD) or with a matching CBD placebo for 8 weeks. The study will examine CBD as an augmentation strategy in early psychosis. It is hypothesized that CBD will improve symptoms, neurocognition, markers of inflammation and eating behaviors. Importantly, moderators and mediators of the CBD effects will be explored.

    at UCSD

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

    open to eligible people ages 13-25

    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 UCSD UCSF

  • Improving Cognition Through Telehealth Aerobic Exercise and Cognitive Training After a First Schizophrenia Episode

    open to eligible people ages 18-45

    The participants in the study will receive psychiatric treatment at the UCLA Aftercare Research Program. All participants in this 12-month RCT will receive cognitive training. Half of the patients will also be randomly assigned to the aerobic exercise and strength training condition, and the other half will be randomly assigned to the Healthy Living Group condition. The primary outcome measures are improvement in cognition and level of engagement in the in-group and at-home exercise sessions. Increases in the level of the patient's serum brain-derived neurotropic factor (specifically Mature BDNF) which causes greater brain neuroplasticity and is indicator of engagement in aerobic exercise, will be measured early in the treatment phase in order to confirm engagement of this target. In order to demonstrate the feasibility and portability of this intervention outside of academic research programs, the interventions will be provided via videoconferencing. The proposed study will incorporate additional methods to maximize participation in the exercise condition, including the use of the Moderated Online Social Therapy (MOST) platform to enhance motivation for treatment based on Self-Determination Theory principles, and a "bridging" group to help the participants generalize gains to everyday functioning. In addition, the exercise group participants will receive personally tailored text reminders to exercise.

    at UCLA

  • iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders

    open to eligible people ages 18-65

    People with psychotic disorders experience a high level of functional disability, and a major contributor to this disability is introspective accuracy, which is defined as inaccurate judgements of one's abilities and performance on tasks. Yet, no intervention has directly targeted introspective accuracy for psychotic illnesses. This trial will evaluate a new intervention, called iTEST, that uses mobile devices to train people with psychotic disorders to improve introspective accuracy and, ultimately, functional outcomes

    at UCSD

  • Luteolin for the Treatment of People With Schizophrenia

    open to eligible people ages 18-60

    Luteolin is a natural product found in foods such as celery, green pepper, parsley, and chamomile tea. It has been found to have anti-cancer, anti-oxidant, and anti-inflammatory properties. The purpose of this study is to determine if luteolin helps improve symptoms of schizophrenia.

    at UCLA

  • Memantine Augmentation of Targeted Cognitive Training in Schizophrenia

    open to eligible people ages 18-65

    Treatment of schizophrenia currently includes antipsychotic medications and cognitive therapies which improve some symptoms, but do not sufficiently restore cognitive functioning or reduce psychosocial disability. We hypothesize that medications that specifically target sensory information processing deficits, rather than psychotic symptoms per se, will significantly enhance the benefits of a sensory-based targeted cognitive training (TCT) intervention in patients with schizophrenia. We will complete a randomized, double-blind clinical trial to: 1) confirm that the drug memantine augments TCT learning; 2) determine whether memantine enhances the clinical benefits from a full 30 session course of TCT vs. TCT plus placebo in antipsychotic- medicated schizophrenia patients, and 3) determine if memantine's enhancement of TCT is most effective in biomarker-defined subgroups of patients.

    at UCSD

  • Multiomic Diagnostics in Youth With Psychosis

    open to eligible people ages 7-17

    Rady Children's Institute for Genomic Medicine seeks to understand the genomes and immune systems in 15 children and adolescents who are admitted to Rady Children's Hospital Child and Adolescent Psychiatry Service with psychotic symptoms or schizophrenia. Cutting-edge genome and protein sequencing technology will be used to better understand how immunological and genetic assessments may improve our ability to identify the cause of psychosis and impact care. The investigator also hopes to identify new genetic and/or autoimmune causes of psychosis that may inform new treatment for future patients.

    at UCSD

  • Optimizing CBSST With Executive Function Training for Schizophrenia

    open to eligible people ages 60 years and up

    The purpose of this research study to test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). The aims include determining whether E-CBSST is feasible and increases Cognitive Behavioral Social Skills Training (CBSST) Skills Learning to a level that will lead to a clinically meaningful improvement in functioning.

    at UCSD

  • Optimizing Engagement in Services for First-Episode Psychosis

    open to eligible people ages 15-35

    This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care (i.e., treatment-as-usual; TAU) delivered over 6 months with a sample of Latinos with FEP and their families. Comparable family group sessions will also be delivered to participants in both conditions. It is expected that BA participants will show better engagement than TAU participants.

    at UCLA

  • 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

  • Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis

    open to eligible people ages 40 years and up

    Patients with Parkinson's disease (PD) sometimes experience symptoms affecting their movement, such as slowness, tremor, stiffness, and balance or walking problems. Many patients also have other symptoms not related to movement, called non-motor symptoms, which may affect one's mood or emotions, memory or thinking, or cause one to see or hear things that aren't real (hallucinations) or believe things that aren't true (delusions). Hallucinations or delusions, together called psychosis, occur in up to 60% of PD patients at some point in time. Parkinson's disease psychosis can sometimes be associated with decreased quality of life, increased nursing home placement, increased rate of death, and greater caregiver burden. There are approximately 50,000 Veterans with Parkinson's disease receiving care in the VA, and up to 30,000 (60%) of them will experience psychosis at some point in time. Quetiapine is an antipsychotic drug approved by the Food and Drug Administration (FDA) that is the most commonly used medication to treat PD psychosis, but more studies are needed to determine if it works for this condition and is also well tolerated and safe. Pimavanserin is a newer antipsychotic drug approved by the Food and Drug Administration (FDA) specifically to treat PD psychosis, but more studies are needed to determine if it works and its safety. The purpose of this research is to gather additional information on the safety and effectiveness of both Quetiapine and Pimavanserin. By doing this study, the investigators hope to learn which of these medications is the most effective course of treatment for people with PD psychosis.

    at UCSF

  • Sacramento Clinical High Risk for Psychosis Stepped-Care Program

    open to eligible people ages 12-25

    This is a dissemination and implementation study that is evaluating a stepped-care intervention for identifying and treating youths at clinical high-risk for psychosis within multiple community mental health centers.

    at UC Davis

  • AMP SCZ® Observational Study: PREDICT-DPACC

    open to eligible people ages 12-30

    The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons. The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits.

    at UC Irvine UCLA UCSD UCSF

  • California Collaborative Network to Promote Data Driven Care and Improve Outcomes in Early Psychosis

    Sorry, accepting new patients by invitation only

    The proposed project seeks to create a California early psychosis network using a core assessment battery of valid, low burden measures and mHealth technology platform to collect client-level data, visualize data via clinician dashboard for treatment planning, and integrate across clinics to provide de-identified data to the national coordinating hub. Research capacity for the network will be tested via development and validation of a measure of the Duration of Untreated Psychosis (DUP) that is feasible for use in community settings. The proposed California network will contribute systematically collected outcomes data on over 100 FEP clients per year, from 12 community and university EP clinics, to enhance the development of a national EP network, supported by the NIMH EPINET program.

    at UC Davis UCSF

  • Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial

    Sorry, not currently recruiting here

    Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine the effects of treatment with clozapine vs antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings

    at UCLA

  • Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness

    Sorry, in progress, not accepting new patients

    This open trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.

    at UCSD

  • Enhancing Rehabilitation for Veterans With Serious Mental Illness

    Sorry, not yet accepting patients

    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.

    at UCSD

  • Obstructive Sleep Apnea Treatment in Serious Mental Illness

    Sorry, not yet accepting patients

    Serious mental illnesses (SMI) like schizophrenia and bipolar disorder are two of the most disabling and costly chronic illnesses worldwide. A high proportion of adults with schizophrenia and bipolar disorder have sleep disorders, like obstructive sleep apnea (OSA), but tend to be underdiagnosed and undertreated compared to the general population. This study aims to examine feasibility, acceptance, and impact of OSA treatment and how it affects cognitive function in people with SMI.

    at UCSD

  • Youth Nominated Support Team

    Sorry, not yet accepting patients

    This study aims to adapt the current Youth-Nominated Support Team (YST) manual used to treat suicide risk for people at clinical high risk for psychosis.

    at UC Irvine

Our lead scientists for Psychotic Disorders research studies include .

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