Clinical Trials

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.

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.

This study aims to evaluate the TEACCH School Transition to Employment and Post-Secondary Education (T-STEP) Program. Through randomized assignment, adolescents and young adults (16-21-year-old) on the autism spectrum without intellectual disability will participate in the full T-STEP Program or a counseling only condition. Effectiveness will be assessed by caregiver report (social communication, executive function, employment readiness), self-report (self-determination, coping, depression), and behavioral observation (i.e., a mock employment experience). The long-term impact of this intervention is to promote a more positive quality of life for young adults with autism and without intellectual disability, including increased postsecondary education completion, employment, self-determination, and decreased difficulties with coping and depression.

The purpose of the proposed study is to conduct an alternative treatment randomized clinical trial (RCT) to examine the efficacy of the TEACCH School Transition to Employment and Postsecondary Education (T-STEP) Program, a 12-week transition intervention targeting specific challenges that young adults with ASD experience in executive function, social communication, and emotion regulation including group intervention, internship, and counseling services, compared to counseling services only. All participants complete a Screening Phone Visit to document age, diagnosis of autism, and educational experiences. Then participants will complete a virtual eligibility visit with an interview, IQ test, and short questionnaires. Eligible participants will be randomly assigned to the T-STEP Comprehensive intervention condition or the Counseling Only Condition. The Pre-Assessment visit will include 30 minutes of behavioral measures and 1 hour for self-report measures, as well as 1 hour for caregivers to complete questionnaires. The intervention involves 12 weeks of programming in community college settings. Participants in the comprehensive T-STEP program receive 36 hours of group-based instruction delivered within a traditional school academic semester (i.e., 24 ninety-minute classes across 12 weeks). Students also participate in a weekly community-based internship to practice the skills learned in the intervention group (2 hours per week for 12 weeks). In addition, students participate in 12 hours of manualized individual counseling services that are traditionally available on a college campus (e.g., job exploration/career counseling, academic counseling, and self-advocacy counseling). Participants in the Counseling Only condition will receive the same manualized counseling sessions that are included in the T-STEP program described above. Specifically, 12 hours of individual counseling focused on job exploration/career counseling, academic counseling, and self-advocacy counseling. Participants in both conditions will complete post-assessments immediately following treatment and a follow-up assessment 4 months (week 28) after finishing the treatment. Both assessments will take approximately 1.5 hours to complete by students with ASD and 1 hour to complete by caregivers.

Inclusion criteria for the study includes: (a) 16-21 years old; (b) Has a previous diagnosis of autism to be confirmed by 1) an educational diagnosis of ASD as determined by a high school IEP for autism services; and/or (2) a psychological evaluation report; (c)Report documenting the diagnosis of ASD within the past 5 years; (d)Has a minimum Full-Scale IQ score of 80 as assessed by the Wechsler Abbreviated Scale of Intelligence-II; (e) Has a parent or other family member/surrogate who has regular contact with the young adult who will attend the assessment visit and report on the young adult’s behaviors and (f)English speaking.

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)

We are conducting a research study to examine the effect birth control has on eating behaviors in women who overeat or binge eat. This is done by taking study prescribed birth control for 3-months while we monitor your eating behaviors.

Total study participation lasts approximately 4-months and requires 6 study visits and 2 brain scans. Study participants will be asked to complete a clinical health screening appointment, clinical interview, a series of questionnaires, and take study medications.

After a month-long screening period, participants will take study prescribed birth control for 3-months and complete online surveys weekly. While on the study medication, you will also have monthly visits with the study team and complete two brain scans in order to take pictures of your brain. Study visits will range from 45-minutes to 3-hours. Portions of the study visits can occur remotely and some visits may occur in your home.

Research participants will receive the study prescribed birth control for free for 3-months and can receive up to $200 in compensation at the end of study. At the end of the study, participants will also receive a comprehensive and personalized report about how their eating behaviors may have changed while taking the birth control. This may be useful for managing eating behaviors in the future or for treatment planning purposes with a treatment provider.

You may be eligible for this study if you are:

• Age 18-34
• Regular menstrual cycle
• Experience overeating or binge eating
• Not currently taking birth control
• Not a current smoker

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.

In this study, we are observing the way ovarian hormones, such as estrogen, affect behaviors in people who have bulimia nervosa. Past research has shown that certain behaviors in females with bulimia nervosa change over the menstrual cycle, but it is unclear exactly which hormones are involved in this change or why this change occurs. Participants in this study will take hormones while we regularly monitor certain behaviors. By taking hormone medications, we hope to better understand how these hormones influence behaviors in people with bulimia nervosa.

Total study participation lasts approximately 4-months and requires 9 study visits. Study participants are asked to complete a clinical health screening appointment, clinical interview, a series of questionnaires, and take study medications and complete surveys daily for 3 consecutive months.

After a month-long screening period, participants take hormones for 3-months. The study requires study visits every 2-weeks during the 3-month medication period. Some of these visits may last approximately 3-hours while some are shorter, lasting approximately 45-minutes. Portions of these study visits can occur remotely and some may occur in your home.

Eligible participants can receive up to $900 in compensation at the end of study. Study participants will also receive a comprehensive and personalized report about how their behaviors may have changed while taking study medications. This may be useful for managing eating disorder symptoms in the future or for treatment planning purposes with a treatment provider.

You may be eligible for this study if you are:

• Age 18-35
• Biological female
• Currently have bulimia nervosa
• Have a regular menstrual cycle
• Haven’t skipped a menstrual period in the past 3 months
• Not currently taking birth control

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.

Adults (ages 18-70) with a diagnosis of Major Depressive Disorder may be eligible to participate in a research study to evaluate a new treatment for alleviating MDD symptoms that is self-administered with an investigational medical device. The study device is non-invasive and is used by participants at home at convenient times. Compensation for time and travel is available for eligible participants. To find out more, please contact the study team: MOOD_Study@unc.edu

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

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

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)

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

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