{"id":11870,"date":"2021-09-16T13:25:04","date_gmt":"2021-09-16T17:25:04","guid":{"rendered":"https:\/\/www.med.unc.edu\/psych\/cecmh\/?page_id=11870"},"modified":"2022-10-04T15:53:24","modified_gmt":"2022-10-04T19:53:24","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/psych\/cecmh\/research\/clinical-trials\/","title":{"rendered":"Clinical Trials"},"content":{"rendered":"<div role=\"tablist\" class=\"panel-group yourcustomclass oscitas-bootstrap-container\" id=\"unc-accordion-0\">\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-0\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h2 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-0\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-0\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-0\">\n                A Multi-Center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-Occurring Schizophrenia and Substance Use Disorder            <\/button>\n\n        <\/h2>\n\n    <\/div>\n\n    <div id=\"details-0-0\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">\n<p>The purpose of this research study is to examine whether the drug brexpiprazole, a recently FDA approved antipsychotic medication can help reduce substance use in individuals diagnosed with schizophrenia or schizoaffective disorder.<\/p>\n<p><strong>Participant Information:<\/strong><\/p>\n<ul>\n<li>The study will last approximately 12 weeks<\/li>\n<li>Weekly research visits<\/li>\n<li>Vital signs, blood draws, and urine samples<\/li>\n<li>Answering questions about substance use and current psychiatric symptoms<\/li>\n<li>Participants will receive either brexpiprazole or continue current antipsychotic treatment<\/li>\n<li>Will receive up to $375 for study completion<\/li>\n<\/ul>\n<p>You may be eligible to participate in this study if you:<\/p>\n<ul>\n<li>Are 18-65 years of age<\/li>\n<li>Have schizophrenia disorder AND substance use disorder (alcohol, cannabis, cocaine, or heroin)<\/li>\n<li>Are taking medication for schizophrenia or schizoaffective disorder<\/li>\n<\/ul>\n<p><strong>For more information, please contact:<br \/>\n<\/strong>PI: Dr. Lars Fredrik Jarskog<br \/>\nStudy Coordinator: Tonya Elliott and\/or Terry Edwards (919)966-3915<\/p>\n<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-1\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h2 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-1\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-1\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-1\">\n                A Phase II Randomized, Double-Blinded, Placebo-Controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily with Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients with Schizophrenia            <\/button>\n\n        <\/h2>\n\n    <\/div>\n\n    <div id=\"details-0-1\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">\n<p>This study tests whether BI 425809 together with brain training using a computer improves mental functioning in patients with schizophrenia. This is a 12 week, randomized, double-blind, placebo controlled parallel group trial in patients with schizophrenia on stable antipsychotic treatment. There will be a total of seven visits during the study. Exam, assessments, cognition testing and CCT compliance will be requited. Blood and urine samples will be taken during the course of the study participation.<\/p>\n<p>You may be eligible to participate in this study if you are:<\/p>\n<ul>\n<li>male or female patients who are 18-50 years of age at time of consent<\/li>\n<li>established schizophrenia DSM-5<\/li>\n<li>patients must be on stable antipsychotic treatment<\/li>\n<li>patients must demonstrate their ability to properly use the CCT device program<\/li>\n<li>patients must have a study partner who will preferably be consistent throughout the study<\/li>\n<\/ul>\n<p><strong>For more information, please contact:<br \/>\n<\/strong>PI: Dr. Lars Fredrik Jarskog<br \/>\nStudy Coordinator: Tonya Elliott (<a href=\"mailto:tonya_elliott@med.unc.edu\" target=\"_blank\" rel=\"noopener noreferrer\">tonya_elliott@med.unc.edu<\/a>) or 919-966-3915<\/p>\n<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-2\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h2 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-2\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-2\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-2\">\n                A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients with Schizophrenia and Recent Weight Gain While Taking Antipsychotic Medications (EDGI)            <\/button>\n\n        <\/h2>\n\n    <\/div>\n\n    <div id=\"details-0-2\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">\n<p>The purpose of this study is to find out whether the investigational study drug miricorilant is safe and effective in reducing the weight gain in obese participants taking antipsychotic medications. This study also includes an optional pharmacokinetic (PK) substudy. This PK substudy will be performed to understand how miricorilant is absorbed, broken down and removed from your body.<\/p>\n<p>Participation in this study if for approximately 20 weeks (4 weeks of screening, 12 weeks of study treatment, and 4 weeks of follow-up). The study consists of the following study periods:<\/p>\n<ul>\n<li>Screening Period: up to 28 days<\/li>\n<li>Treatment Period: Day 1 to Week 12<\/li>\n<li>Follow-up Period: 4 weeks after last study dose (Week 16)<\/li>\n<\/ul>\n<p>You may be eligible to participate in this study if you are:<\/p>\n<ul>\n<li>Patients with a body mass index (BMI) \u226530 kg\/m2 who have started olanzapine, risperidone, or<br \/>\nquetiapine therapy for the treatment of schizophrenia within the last 12 months and have since shown<br \/>\nan increase in body weight by \u22655% within 6 months of starting the medication as documented by<br \/>\nmedical record or treating physician\u2019s report.<\/li>\n<li>Are men or women \u226518 to \u226465 years old<\/li>\n<li>Able to successfully complete placebo tablet swallow assessment<\/li>\n<li>Meet the criteria for schizophrenia based on medical history and the Mini International Neuropsychiatric Interview (MINI). Patients who have a questionable diagnosis based on the MINI, should have the diagnosis ofschizophrenia verified by the Structured Clinical Interview for Diagnostic and Statistical Manual V (DSM-V) (SCID)<\/li>\n<li>Have started olanzapine, risperidone, or quetiapine within 12 months of screening and have since shown an increase in body weight of \u22655% above their prior body weight within 6 months of medication initiation as documented by medical record or physician\u2019s report. Historical weights from medical records must be within 6 months prior to medication initiation<\/li>\n<li>Have been on the same dose of olanzapine, risperidone, or quetiapine for the last month prior to screening<\/li>\n<li>Are clinically stable and unlikely to require change to their antipsychotic medication (i.e. medication switch or dose change) through the duration of the study (12 weeks)<\/li>\n<li>Have a Brief Psychiatric Rating Scale (BPRS) of \u226450 on screening interview<\/li>\n<li>Have a BMI \u226530 kg\/m2<\/li>\n<\/ul>\n<p><strong>For more information, please contact:<br \/>\n<\/strong>PI: Dr. Lars Fredrik Jarskog<br \/>\nStudy Coordinator: Jesi Post (<a href=\"mailto:jesi_post@med.unc.edu\" target=\"_blank\" rel=\"noopener noreferrer\">jesi_post@med.unc.edu<\/a>) or 919-445-0295 <\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-3\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h2 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-3\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-3\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-3\">\n                Improving Cognition via Exercise (ICE) in Schizophrenia            <\/button>\n\n        <\/h2>\n\n    <\/div>\n\n    <div id=\"details-0-3\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">\n<div dir=\"auto\">\n<p>The purpose of this research study is to test the effectiveness of exercise on cognition in people with schizophrenia. It has been shown that people with schizophrenia may have some cognitive deficits. Findings from an earlier pilot study, along with recent reports, suggest that aerobic exercise may be effective in improving cognitive functioning in people with schizophrenia.<\/p>\n<p>Following a baseline research assessment, participants will be randomized into aerobic exercise training or stretching and toning training. Participants in both groups will take part in a 12-week, 3 times per week, 1-hour training program, in addition to their regular treatment. All participants may continue to see their current psychiatrist for their pharmacological treatment during the study.<br \/>\nAt baseline, week six and end of study; assessments, questionnaires, cognitive testing and a test called VO2 max (to test maximal oxygen consumption) will be performed. In addition, urine and blood samples will be taken.<\/p>\n<p>You may be eligible to participate in this study if you are:<\/p>\n<ul>\n<li>Male or female between the ages of 18 and 55.<\/li>\n<li>English speaking.<\/li>\n<li>DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.<\/li>\n<li>Taking antipsychotic medication for at least 8 weeks and on current doses for 4 weeks, and\/or injectable depot antipsychotics with no change in last 3 months.<\/li>\n<li>No more than moderate degree of disorganization.<\/li>\n<li>No use of street drugs within the past 4 weeks.<\/li>\n<li>No history of severe hypertension or serious cardiac conditions.<\/li>\n<li>No history of active suicidal ideation, serious self-destructive behavior, violence or aggressive behavior (previous 2 years).<\/li>\n<li>No history of neurological or medical conditions known to seriously affect the brain.<\/li>\n<li>Capacity to give informed consent.<\/li>\n<li>Currently not pregnant or nursing.<\/li>\n<li>No participation in a study of cognition during the previous 3 months.<\/li>\n<\/ul>\n<\/div>\n<div dir=\"auto\">\n<div dir=\"auto\">\n<p><strong>For more information, please contact:<br \/>\n<\/strong>PI: Dr. Lars Fredrik Jarskog<br \/>\nStudy Coordinator: Terry Edwards (<a href=\"mailto:terry_edwards@med.unc.edu\" target=\"_blank\" rel=\"noopener noreferrer\">terry_edwards@med.unc.edu<\/a>) or call 919-445-0271 or 919-966-3915<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n    <\/div>\n        \n<\/div>\n\n<div class=\"panel panel-default oscitas-bootstrap-container\">\n\n    <div id=\"panel-heading-details-0-4\" class=\"panel-heading oscitas-bootstrap-container\" role=\"tab\">\n\n        <h2 class=\"panel-title oscitas-bootstrap-container\">\n\n            <button class=\"accordion-toggle oscitas-bootstrap-container collapsed\" \n                id = \"button-details-0-4\"\n                data-toggle=\"collapse\"\n                data-parent=\"#unc-accordion-0\"    \n                aria-controls=\"#details-0-4\"  \n                aria-expanded=\"false\" \n                href=\"#details-0-4\">\n                Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia            <\/button>\n\n        <\/h2>\n\n    <\/div>\n\n    <div id=\"details-0-4\" class=\"panel-collapse collapse  oscitas-bootstrap-container\">\n\n        <div class=\"panel-body oscitas-bootstrap-container\">\n<p>Researchers at the UNC School of Medicine are studying the efficacy of pyridoxine, a form of Vitamin B6, for the treatment of involuntary muscle movements in people with tardive dyskinesia.<\/p>\n<p><strong>Frequently Asked Questions:<\/strong><\/p>\n<ul>\n<li>How long does the study last?-\u00a0 The study lasts approximately 10 weeks.<\/li>\n<li>What happens during a study visit? \u2013 The study involves interviews, questionnaires, video recordings and labs.<\/li>\n<li>Where does the study take place? \u2013 We have two study locations, Chapel Hill and Raleigh. You can choose the location that is most convenient for you.<\/li>\n<li>Do participants get paid? \u2013 Participants are paid at each study visit and can earn up to $225 total for completing the 7 study visits.<\/li>\n<\/ul>\n<p>You may be eligible to participate in this study if you are:<\/p>\n<ul>\n<li>18-80 years old<\/li>\n<li>Have involuntary muscle movements or Tardive Dyskinesia (TD)<\/li>\n<li>Have had 3 or more months of antipsychotic exposure<\/li>\n<\/ul>\n<p><strong>For more information, please contact:<br \/>\n<\/strong>PI: Dr. Lars Fredrik Jarskog<br \/>\nStudy Coordinator: Jesi Post (<a href=\"mailto:jesi_post@med.unc.edu\" target=\"_blank\" rel=\"noopener noreferrer\">jesi_post@med.unc.edu<\/a>) or 919-445-0295<\/p>\n<\/div>\n\n    <\/div>\n        \n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":97082,"featured_media":0,"parent":2226,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-11870","page","type-page","status-publish","hentry","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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