Clinical Trials

A multi-center, randomized, controlled trial of brexpiprazole for the treatment of co-occurring schizophrenia and substance use disorder

Actively Recruiting Study Participants

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.

Participant Information:

• The study will last approximately 12 weeks
• Weekly research visits
• Vital signs, blood draws, and urine samples
• Answering questions about substance use and current psychiatric symptoms
• Participants will receive either brexpiprazole or continue current antipsychotic treatment
• Will receive up to $375 for study completion

You may be eligible to participate in this study if you:

• Are 18-65 years of age
• Have schizophrenia disorder AND substance use disorder (alcohol, cannabis, cocaine, or heroin)
• Are taking medication for schizophrenia or schizoaffective disorder

For more information, please contact:
PI: Dr. Lars Fredrik Jarskog
Study Coordinator: Tonya Elliott and/or Terry Edwards (919)966-3915

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

Actively Recruiting Study Participants

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.

You may be eligible to participate in this study if you are:

• male or female patients who are 18-50 years of age at time of consent
• established schizophrenia DSM-5
• patients must be on stable antipsychotic treatment
• patients must demonstrate their ability to properly use the CCT device program
• patients must have a study partner who will preferably be consistent throughout the study

For more information, please contact:
PI: Dr. Lars Fredrik Jarskog
Study Coordinator: Tonya Elliott (tonya_elliott@med.unc.edu) or 919-966-3915

A Phase 2, 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

Actively Recruiting Study Participants

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.

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:

• Screening Period: up to 28 days
• Treatment Period: Day 1 to Week 12
• Follow-up Period: 4 weeks after last study dose (Week 16)

You may be eligible to participate in this study if you are:

• Patients with a body mass index (BMI) ≥30 kg/m2 who have started olanzapine, risperidone, or
  quetiapine therapy for the treatment of schizophrenia within the last 12 months and have since shown
  an increase in body weight by ≥5% within 6 months of starting the medication as documented by
  medical record or treating physician’s report.
• Are men or women ≥18 to ≤65 years old
• Able to successfully complete placebo tablet swallow assessment
• 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)
• Have started olanzapine, risperidone, or quetiapine within 12 months of screening and have since shown an increase in body weight of ≥5% above their prior body weight within 6 months of medication initiation as documented by medical record or physician’s report. Historical weights from medical records must be within 6 months prior to medication initiation
• Have been on the same dose of olanzapine, risperidone, or quetiapine for the last month prior to screening
• 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)
• Have a Brief Psychiatric Rating Scale (BPRS) of ≤50 on screening interview
• Have a BMI ≥30 kg/m2

For more information, please contact:
PI: Dr. Lars Fredrik Jarskog
Study Coordinator: Jesi Post (jesi_post@med.unc.edu) or 919-445-0295

BI 1289-0032 Research Study

Actively Recruiting Study Participants

This study is a phase II randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered BI 409306 during a 52-week treatment period as an early intervention in patients at clinical high risk for psychosis.

Participants will be assigned by chance to receive the investigational drug or placebo. Total participation in this study will last approximately 14 months, which includes about 15 visits to the study center and 10 phone calls from the study doctor or study staff. At each in-person study visit, you will meet with members of the research team to complete research assessments. Each of the remote study visits consists of a brief phone call and the completion of a phone survey. The study also involves blood draws, ECGs, and willingness to take the study medication regularly, as advised.

You may be eligible for this study if you:

• Are 16 to 30 years of age
• Are experiencing trouble thinking clearly or concentrating, believing or hearing things that others do not, losing control of your thoughts, feeling nervous or anxious, feeling that others are “out to get” you, having trouble with family and friends, having thoughts that scare you or the people around you, having trouble at work or school, or other similar symptoms
• Have not been diagnosed with schizophrenia or related disorder
• Are not taking a medication called clozapine

Binge Eating Genetics INitiative (BEGIN)

Actively Recruiting Study Participants

The goal of the BEGIN study is to better understand the genetic factors that may be associated with binge-eating disorder and bulimia nervosa in order to develop better treatments for the millions of people who suffer from these illnesses.

You may be eligible to participate in the BEGIN study if you:

• Have a current or lifetime experience with binge eating disorder (BED) or bulimia nervosa (BN)
• Are over 18 years old and living in the United States
• Have an iPhone (model 5 or newer)

In recent years, genetic testing has become popular for the commercial population as well as for advanced medicine. Here at UNC, we are researching just how helpful those genetic tests are for clinicians whom prescribe psychotropic medications for adults suffering from depression. In coordination with Massachusetts General Hospital, and funding from PCORI foundation, we have just opened this new and exciting research study.

If eligible, we use a simple cheek swab to obtain results. Our dedicated team of clinicians uses these genetic results as they do in real-world scenario’s: to guide their decision making when prescribing psychotropic medications. The results are to be reviewed by a qualified and trained clinician, and it provides insight into tolerability for various medications. Currently, clinicians use what is called “Best Practice Guidelines” to determine optimal medication regimen for their patients. It is possible the use of these genetic test can enhance this process of determining medications to provide, we just don’t know yet!

In order to tell how well this test works, we compare depression surveys of patients and clinician reports from two different groups: one group gets their genetic results right away, the other group waits one year. Research participation lasts one year, and additional monitoring is provided, even as the patient completes their research visits online from the comfort of their home. Both groups continue to be seen for routine care, and those who must wait for their results are prescribed medication according to Best Practice Guidelines, what would normally be done if they weren’t participating in the research. When the research is complete for that individual, those who had to wait will receive their genetic results and their provider can utilize those results as needed

For more information, please contact:
PI: Brad Gaynes
Study Coordinator: Elizabeth Pugliese (elizabeth_pugliese@med.unc.edu) or 984-974-3843 (ex. 0 voicemail)

Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia

Actively Recruiting Study Participants

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.

Frequently Asked Questions:

• How long does the study last?-  The study lasts approximately 10 weeks.
• What happens during a study visit? – The study involves interviews, questionnaires, video recordings and labs.
• Where does the study take place? – We have two study locations, Chapel Hill and Raleigh. You can choose the location that is most convenient for you.
• Do participants get paid? – Participants are paid at each study visit and can earn up to $225 total for completing the 7 study visits.

You may be eligible to participate in this study if you are:

• 18-80 years old
• Have involuntary muscle movements or Tardive Dyskinesia (TD)
• Have had 3 or more months of antipsychotic exposure

For more information, please contact:
PI: Dr. Lars Fredrik Jarskog
Study Coordinator: Jesi Post (jesi_post@med.unc.edu) or 919-445-0295

Research Studying Possible Treatment for Depression in Adolescents with Intermittent Theta Burst Stimulation (iTBS)

Actively Recruiting Study Participants

Transcranial Magnetic Stimulation (TMS) is FDA approved and commonly used for adults with depression, however it is not yet FDA approved for adolescents. UNC is now studying a new type of TMS treatment, called iTBS, for qualifying adolescents 13-17 years old. iTBS is like TMS, but the duration of treatment is much shorter, which will hopefully make treatment more accessible and easier for patients. In addition, we will be monitoring for potential effects of treatment on suicidality and self-injurious behavior. This is an open label, pilot feasibility study.

For more information, please contact:
PI: Dr. Shahzad Ali
Study Coordinator: Elizabeth Pugliese (elizabeth_pugliese@med.unc.edu) or 984-974-3843

Stimulation to Improve Auditory Hallucinations – STILL 3

Actively Recruiting Study Participants

A research study to test whether transcranial alternating current stimulation (tACS) can reduce auditory hallucinations in people with schizophrenia. Transcranial current stimulation is a non-invasive technique that delivers very low intensity current to the scalp; treatment has been well tolerated with only minor side effects such as ‘tingling’ during stimulation. This intervention is aimed at restoring normal brain activity and function to reduce auditory hallucinations. This research represents a promising new non-pharmacological treatment for psychiatric disorders and our findings will serve to enhance the research community’s understanding of schizophrenia.

Involvement: 1 initial phone screening, 2-4 phone screening visits, 5 consecutive visits for treatment, 1 fifteen minute MRI scan, 8 weeks of once weekly stimulation sessions Benefits: Research is designed to benefit society by gaining new knowledge. The ability to target abnormal brain activity could lead to treatments for symptoms in patients with schizophrenia and other psychiatric conditions. There is a small chance that you may experience a reduction in the severity of your auditory hallucinations. At this time we will not offer additional treatments for people who respond well, but you may asked to be informed about future studies. Risks: Mild tingling, burning, or itching underneath the electrodes on the scalp and/or the appearance of flashing lights. Some subjects report headaches. Compensation: Participants will be paid at the end of each session and can earn up to $520.00 for completing all visits.

You may be eligible to participate in this study: Participants must have a diagnosis of schizophrenia or schizoaffective disorder At least 3 auditory hallucinations per week Stable doses of medication for at least 4 weeks Not currently taking benzodiazepine medication

Contact Information:
PI: Dr. Flavio Frohlich
Study Coordinator: Rachel B. Force, PhD (rachel_force@med.unc.edu)
Call the office at 919-966-9929