Clinical Trials

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

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

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

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