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

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)
To determine if you may be eligible and to join the study, please answer a few short questions: BEGIN Preliminary Screen

Development of a Novel Transdiagnostic Intervention for Anhedonia

Actively Recruiting Study Participants

We are conducting a research study to evaluate whether a new form of talk therapy is effective at treating low motivation and pleasure. The study involves a clinical interview, completing questionnaires, and brain scans before and after treatment. Qualified participants receive up to 15 sessions of talk therapy.

Volunteers must be willing to provide informed consent to complete an initial clinical interview, questionnaires regarding mood, anxiety, quality of life, and brain scans before and after treatment. There is no cost to participate. You will receive up to 15 psychotherapy sessions from a Duke clinician. You will receive compensation for the portions of the study you complete.

You may be eligible to participate in this study if you are a between the ages of 18-50 and experiencing symptoms of low motivation and pleasure. Symptoms of low motivation and pleasure can include not wanting to be with other people, not wanting to participate in activities that you previously enjoyed, and feeling numb to the joys of life.

Contact Information:
PI: Dr. Gabriel Dichter
Study Coordinator: Dr. Jessica Kinard (jessica.kinard@cidd.unc.edu) or  919-533-9305

Eating Disorders Genetics Initiative (EDGI)

Actively Recruiting Study Participants
If you have ever struggled with an eating disorder, you might be eligible to participate in the EDGI research study. All eligible participants will get a $20 gift card at the end of the study! And more importantly, you will help us work toward a brighter future with better treatments for all. Visit edgi.org to find out more & take our survey.

Improving Cognition via Exercise (ICE) in Schizophrenia

Actively Recruiting Study Participants

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.

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.
At 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.

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

  • Male or female between the ages of 18 and 55.
  • English speaking.
  • DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.
  • 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.
  • No more than moderate degree of disorganization.
  • No use of street drugs within the past 4 weeks.
  • No history of severe hypertension or serious cardiac conditions.
  • No history of active suicidal ideation, serious self-destructive behavior, violence or aggressive behavior (previous 2 years).
  • No history of neurological or medical conditions known to seriously affect the brain.
  • Capacity to give informed consent.
  • Currently not pregnant or nursing.
  • No participation in a study of cognition during the previous 3 months.

For more information, please contact:
PI: Dr. Lars Fredrik Jarskog
Study Coordinator: Terry Edwards (terry_edwards@med.unc.edu) or call 919-445-0271 or 919-966-3915

Memantine for Prevention of Cognitive Decline in Patients with Breast Cancer

Actively Recruiting Study Participants

The purpose of this study is to determine if memantine may lessen chemotherapy-related cognitive changes experienced by some patients receiving treatment for breast cancer. Participants will complete some questionnaires and a cognitive test before starting chemotherapy and again after completing chemotherapy. These will take about 1 hour each. The participant will take memantine for the duration of chemotherapy and talk with our research assistant for less than 5 minutes every 2-3 weeks to monitor for medication side effects and any missed doses. We will take blood samples before starting chemotherapy and four weeks after chemotherapy for participants who are not yet post-menopausal to measure hormone levels.

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

  • You have been diagnosed with breast cancer, stages I – III
  • You are scheduled to begin chemotherapy
  • You are age 18 or older
  • You are English speaking
  • You are able to provide informed consent

A $25 gift card will be given for completion of the pre-study assessment, and another $25 will be given for completion of the post-study assessment. The study medication, memantine, will be provided at no cost.

Contact Information:
PI: Dr. Zev Nakamura
Study Coordinator: Kate Stanton (kate_stanton@med.unc.edu)

Mindful Self-Compassion for Transgender or Gender Expansive Teens

Actively Recruiting Study Participants

The purpose of the study is to assess the effects of an evidence-based mindful self-compassion intervention in transgender or gender expansive teens, as measured by pre and post mental health assessment instruments. Teens will participate in the Mindful Self-Compassion-Teen course, an 8-session skills-based group intervention to foster self-compassion and mindfulness. Teens will complete online surveys regarding well-being immediately following the course and 3 months post course.

After preliminary screening, participants will be asked to complete a pre-intervention survey about their mental health, incorporating standardized measures of mental health.The self-compassion intervention will be implemented as an eight session course, with each session lasting 1.75 hours, either in person on UNC campus (preferably) or, if not possible due to extenuating circumstances, online via a secure server, i.e., Zoom. The session will be led by two certified instructors and will include group-based exercises, short videos and discussions designed to promote self-compassion. A post-intervention survey will be administered immediately following completion of the program and again at 3-months post-intervention, incorporating the same measures as the pre-intervention survey. Feasibility and acceptability will be assessed via attendance and retention data, post-intervention surveys, and a 30 minute post-intervention interview.

You may be eligible to participate in this study if you are a adolescent who self-identify as transgender or gender expansive, and who are between the ages of 13 and 17. If the study is performed online, the participants would need to have access to a computer or other online device.

Contact Information:
PI: Dr. Karen Bluth
Study Coordinator: Dr. Melissa Clepper-Faith (mscteens@unc.edu) or  919-966-0537

Pharmacogenetics: Precision Medicine in Psychiatry?

Patients are referred to the research team from participating clinicians only

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 (Intermittent Theta Burst Stimulation), 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 see our contact information below.

Contact Information:
PI: Dr. Shahzad Ali Dr. Robert McClure
Study Coordinator: Elizabeth Pugliese (elizabeth_pugliese@med.unc.edu)
Call the office at 984-974-3843

Uniting Couples in the Treatment of Eating Disorders (UNITE)

Actively Recruiting Study Participants

UNITE is a collaborative treatment study between the UNC Center of Excellence for Eating Disorders and the UNC Department of Psychology and Neuroscience  that is examining two different treatments for binge-eating disorder (BED).  UNITE is sponsored by the National Institute of Mental Health.

Participation in UNITE includes 16 weeks of study-related treatment conducted by experienced therapists. There is no cost to you to participate in this study. We are now offering this treatment remotely so that you can participate from the convenience of your home. Your progress will be monitored up to 6 months after treatment. You will also complete questionnaires and receive up to $100 for your time.

For more information, please call our study coordinator at (919) 962-2932 or email us at UNITE@unc.edu.

WIN Study

Actively Recruiting Study Participants

The UNC Center for Women’s Mood Disorders is studying the effect of hormones on mood during and after pregnancy. Women in this research study take commonly used medications to increase and decrease their hormone levels. The study involves answering questions about mood and taking pictures of the brain using a fMRI brain scan to learn how the brain works when hormone levels are high and when they are low, and the study lasts about 12 weeks.

This research study involves taking prescription medication to increase and decrease your hormone levels. We want to learn how these hormones change mood and how the brain works, you would have 2 MRI brain scans. You would have to 8 appointments over the course of 12 weeks and rate your mood on a daily basis. In the context of COVID-19 you would have an maximum of 3 visits which would require you to come to UNC, the rest of your appointments would be done through video. Before starting the medication, you would answer questions about your mood and health, receive a physical exam, and make mood ratings each day. You will learn more about the study and decide whether to join at the first appointment.

You may be eligible to participate in this study if you are a healthy mother between the ages 22-45, at least 1 year postpartum, with a regular periods, with a history of depression during or after pregnancy or have never had depression.

Contact Information:
PI: Dr. Crystal Schiller
Study Coordinator: Laura Lundegard (laura_lundegard@med.unc.edu) or  919-966-5243
Study Facebook page