22 Clinical Trials for Various Conditions
The goal of this feasibility and acceptability trial is to learn about the acceptability of adding a recovery-oriented, psychological framework to a standard medication management appointment with a psychiatrist and any impact on attendance and functioning. The main question\[s\] it aims to answer are: 1. Will CT-R medication checks will be acceptable to the patient and feasible to deliver and receive, as measured by asking patients how they like the CT-R med checks and our ability to do this study in addition to number of patient drop-outs? 2. Will CT-R medication checks will be related to significantly greater engagement with treatment as measured by: lower no-show rates, greater self-reported working alliance, and better treatment adherence? 3. Will CT-R medication checks will be related to greater activity and increase in functioning as measured by: time use survey, GAF, skill use? 4. Will CT-R medication checks will be related to a trend in improved defeatist beliefs, negative symptoms, paranoia, and self-esteem? Researchers will compare the group assigned to the trial psychiatrists to a small group who were assigned to non-trial psychiatrists to see if the intervention impacted any of the above questions beyond TAU.
The goal of this double-blind, placebo-controlled randomized clinical trial is to test the effect of 12 weeks of orally administered MitoQ (mitoquinol mesylate) supplementation on cognition in 50 people with early phase schizophrenia-spectrum disorders (E-SSD) who have mitochondrial dysfunction (called high risk, or HR). Cognitive impairments in SSD can cause significant disability. Yet, there are no effective treatments for cognitive impairments in SSD. It has been shown that alterations in a certain type of brain cell (parvalbumin interneurons, or PVI) underlie cognitive deficits in SSD. These PVI, which fire at a fast rate, utilize high amounts of energy from the mitochondria and are highly vulnerable to oxidative stress. MitoQ is an antioxidant. Research has shown that, in mice, MitoQ can reduce oxidative stress in the mitochondria. The main question that this clinical trial aims to answer is: • Does MitoQ supplementation, compared to placebo, improve cognition in HR patients? Secondary questions that this clinical trial aims to answer are the following: Does MitoQ supplementation, compared to placebo: * Improve positive and negative symptoms of SSD in HR patients? * Improve functioning in HR patients? * Improve/normalize blood markers of mitochondrial dysfunction in HR patients? The investigators will enroll 100 individuals with E-SSD. These enrolled participants will participate in an initial screening visit to determine if they qualify for the actual clinical trial. At the screening visit, the investigators will ask about psychiatric history to determine diagnosis; ask about medical history; do a physical exam; collect blood and urine samples; do a pregnancy test; and ask participants to bring in their current medications in their original packaging so it is known what they are taking. After the screening visit, the investigators will invite 50 HR patients (identified with a blood test) to continue with the clinical trial. Participants who qualify for the clinical trial will be asked to: * Take a supplement (MitoQ or placebo) once per day for 12 weeks in addition to their usual medications. * Come in for a study visit every 4 weeks over the 16-week study period. At these study visits, the investigators will do a physical exam; ask about symptoms and side effects; take blood and urine samples; and ask questions about general health and well-being, quality of life, mental health, emotional health, and mood. At visits 1 (baseline) and 4 (12 weeks), participants will also take a cognitive assessment.
Longitudinal observational study of the relationship between speech patterns and clinical symptoms in schizophrenia spectrum disorders.
This is an open-label extension study to continue to evaluate the safety, tolerability and efficacy of the Repetitive Transcranial Magnetic Stimulation (rTMS) in subjects with schizophrenia or schizoaffective disorder who previously completed the treatment study of the protocol #8116 (NCT05319080). Protocol #8116 investigates the clinical efficacy of open-label individualized MRI-guided TMS applied to the left temporoparietal junction (TPJ) in schizophrenia patients. Participating patients who have completed the 4-week project #8116 can be screened for eligibility for this extension study in which they will continue treatment/assessment. They will be divided into three groups (non-responders, partial responders, or full responders) based on a reduction in the Auditory Hallucination Rating Scale (AHRS) scores from the study #8116.
The Repetitive Transcranial Magnetic Stimulation (rTMS) is a type of brain stimulation that uses a magnet to change activity in the brain. rTMS uses magnetic pulses to induce an electrical current in the brain to alter brain activity and function in specific areas. For example, stimulating the part of the brain controlling movement will cause parts of the foot or leg to twitch. TMS is proposed as a novel treatment for people with schizophrenia. The investigators want to see if low frequency rTMS can lessen some of the symptoms of schizophrenia, specifically auditory verbal hallucinations. Auditory verbal hallucinations describe the experience of hearing voices that are not really there.
To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.
People with schizophrenia display a broad range of cognitive impairments that have been identified as major determinants of poor functioning and disability. Also, people with schizophrenia are at increased risk for suicide, with approximately 40-50% of individuals attempting to take their own lives during their lifetime. The goal of the proposed study is to examine the impact of remote exercise training on cognition, suicide risk, daily functioning, and biomarkers of cognitive change and suicidality in people with schizophrenia.
It is well established in the scientific literature that people with schizophrenia smoke tobacco cigarettes at rates up to three times that of the general population, relapse more frequently, and die an average of 25 years earlier from cigarette smoking and other life-style attributable illnesses. Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide and new research suggests that e-cigarettes are appealing to smokers with schizophrenia. There is a paucity of research focused on the experience of smokers with schizophrenia who decide to try an e-cigarette. A well-designed prospective-observational study is needed to learn more about the influence of e-cigarette use on cigarette smoking behavior and mental and physical health among smokers with schizophrenia. In response, the investigators have designed a study titled, Role of an electronic cigarette on smoking displacement in smokers with schizophrenia: A prospective 3-month pilot study (SchizEcig).
The purpose of the study is to test the hypothesis that functionally navigated repetitive TMS stimulations to the prefrontal cortex (PFC) modulate aberrant cortical electrical activities at PFC circuitry. The TMS location of the PFC site will be individually localized by the symptom-related functional connectivity between PFC and symptom related areas (such as the auditory and language processing cortex). The investigators predict that such modulation will correct abnormal activities in patients with schizophrenia, reduce symptoms, especially auditory hallucination, and improve working memory/sustained attention performance.
The goal of this randomized clinical trial is to be adequately powered to evaluate the effect of ketogenic metabolic therapy on the quality of life in serious mental illness, schizophrenia, bipolar disorder, major depressive disorder.
The aim of this randomized, controlled trial is to study the effectiveness of a potential new form of pre-arrest jail diversion for people with serious mental illnesses: the Police-Mental Health Linkage System. In the case of an encounter with a police officer, for half of the participants, during the background check, a message will notify the officer that the subject has mental health considerations. The notice contains a phone number of a provider working at the mental health clinic where the subject is receiving services, who can provide telephonic support to the officer. For the other half of participants, the message will not appear to the officers in the case of an encounter.
As specified in the VA Uniform Services Handbook, Family Psycho-Education (FPE) treatment must be available to all Veterans with schizophrenia who could benefit, and their family members. This includes those receiving care at Community Based Outpatient Clinics (CBOCs), and at Psychosocial Rehabilitation and Recovery Centers (PRRCs), whether provided on site, by referral, or by telemental health. However, less than 5% of VA medical centers offer FPE. Clearly, a major challenge is to devise ways to deliver mental health treatments and services to Veterans who need them in ways that meet their needs and preferences. The proposed project will compare the use of a website to deliver FPE to that of in-person delivered FPE. The findings could have profound implications for the VA's ability to improve the reach, use, appeal, and effectiveness of FPE for Veterans with schizophrenia, by using an e-health model that facilitates family involvement.
Many individuals with schizophrenia abuse cannabis at the onset of their illness, portending a poorer course of illness and poorer treatment response. Preliminary evidence suggests that clozapine may uniquely reduce substance use in patients with schizophrenia. The purpose of this study is to establish an effective methodology for studying early treatment with clozapine in patients with co-occurring schizophrenia and cannabis use disorder, while generating pilot data comparing clozapine vs. risperidone on substance use, psychiatric symptoms, side effects, and treatment discontinuation.
The primary purpose of this study is to determine whether naltrexone is effective in the treatment of alcohol dependence and abuse in patients with schizophrenia and schizoaffective disorder. Hypotheses are as follows: hypothesis 1: Naltrexone will be more effective than placebo in reducing alcohol use. hypothesis 2: Patients responding to naltrexone by reducing alcohol use will also show reductions in severity of psychiatric symptoms and utilization of inpatient and emergency psychiatric services. hypothesis 3: Severity of psychiatric symptoms and amount of service utilization will correlate positively with alcohol use.
Cross-sectional observational study of the relationship between speech patterns and psychiatric symptoms and disorders.
Surveys suggest that up to 80% of veterans with a persistent mental illness have a co-occurring substance use disorder. Substance abuse among this population is problematic and often results in poor engagement in treatment and thus, frequent hospitalizations and an unstable illness course. Regarding treatment engagement, data from a VA New Jersey facility indicated that 50% of those veterans discharged from the acute psychiatric hospital unit to outpatient care did not attend their initial screening appointment and another 30% dropped out within six weeks. To assist with the transition from inpatient to outpatient care, we previously developed an eight-week augmentation intervention entitled, Time-Limited Case Management (TLC). TLC integrates evidence-based interventions of 1) Dual Recovery Therapy; 2) Critical Time Intervention Case Management along with 3) Peer Support with the goal of assisting individuals with the transition from inpatient to outpatient care.
This study will evaluate a family intervention program for individuals with bipolar disorder, schizophrenia, or schizoaffective disorder and co-occurring substance use disorders.
This study will determine the effectiveness of the STIRR (Screen, Test, Immunize, Reduce risk, and Refer) intervention in increasing rates of testing, immunization, referral, and treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental disorder and a substance abuse disorder.
Social cognition impairment is critical to the pathology and morbidity of a number of psychiatric disorders, including the schizophrenia spectrum, the autism spectrum and the personality disorders, thus representing a dimension consistent with RDoC. As such, this study aims to a) further characterize the unique deficits in social cognition (recognition and interpretation of social cues and representation of thoughts, intentions, and feelings of others) across disorders, including the schizophrenia spectrum (which includes schizophrenia, SCZ, schizoaffective disorder, SAD, bipolar disorder, BD, and schizotypal personality disorder, SPD), the autism spectrum disorders (ASD), and borderline personality disorder (BPD) compared to healthy controls (HC); b) assess the effect of intranasal oxytocin (OXT) as a regulator and novel treatment of social cognition impairment in these disorders; and c) enhance our understanding of the specificity and exact mechanisms of impairment to inform the accurate dosing of OXT required to modulate social cognition in these disorders and identify a model of optimum social cognitive function. Addressing these questions will further catalyze research into a model of optimum social cognitive activity, and accelerate industry development of agents suited to routine clinical administration.
Older adults with schizophrenia are a growing segment of the population yet their physical health status is poor. In order to design effective interventions, the contributing factors must be understood. Current data suggest the side effects of psychiatric medications, sociodemographic factors, and health care disparities are a few of the reasons for the poor physical health. There are only limited data on the impact of psychiatric symptomatology and neurocognition on the physical health of this population. These limited data indicate that worse symptomatology and poorer neurocognition may negatively impact physical functioning, a critical component to optimal physical health. The purpose of this pilot study is to begin to fill this knowledge gap by: 1. examining the relationship between neurocognitive function and physical function and 2. Examining the relationship between schizophrenia symptoms and physical function. 3. Examining the relationship between serum Brain Derived Neurotrophic Factor (BDNF) and physical function. Using a descriptive correlational design, 50 older adults (55+) with schizophrenia or schizoaffective disorder will be assessed. Bivariate associations will be used to examine the relationship between key variables including schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS), neurocognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB), Physical Function as measured objectively by the Timed Get Up and Go (TGUG) test and subjectively with the physical component summary subscale of the 12-item short form health survey (SF-12), and serum BDNF. These pilot data will lay the foundation for a future health promoting intervention.
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.
During a psychiatric crisis, persons with severe mental illness (SMI) confront complex challenges concerning treatment choices and are often ill equipped or unable to make mental health care decisions. Psychiatric Advance Directives (PADs) are legal documents that allow competent persons to declare their treatment preferences in advance of a mental health crisis, when they may lose capacity to make reliable health care decisions. The use of PADs is consistent with recommendations of the President�s New Freedom Commission on Mental Illness and the Patient Self-Determination Act; 25 states have now adopted PAD legislation. VA does not have a specific policy for PADs or mechanisms to notify veterans of their right to prepare PADs. The downstream effects of PADs on patient care, crisis management, service use, and clinical outcomes are unknown.