Clinical Trials
Behavioral Health Trials
This study looks to further examine the ways in which stress related to the Covid-19 pandemic impacts healthcare workers. Avoidance, hyperarousal, and saliva/blood samples are the biomarkers that will be measured as the workers watch two videos created. The first video is a News-based stress task (NCST), which depicts interviews of individuals sharing Covid-19 related traumatic experiences. The second video is a progressive muscle relaxation video (PMR), which will allow us to evaluate their ability to recover from stress.
The purpose of the study is to validate a film-based behavioral task that will assess how Covid-19-related social stress drives changes in hyperarousal, avoidance, and peripheral biomarkers.
You may be eligible to participate in this study if you are a healthy healthcare personnel between the ages of 25-50.
What will be asked of you?
• 1 (one) phone screen
• 1 (one) enrollment session (Zoom Session)
• 1 (one) in-lab visit (2 hours)
• 2 (two) virtual surveys–6 and 12 months after in-lab visit
Contact Information:
PI: Dr. Anthony Zannas
Study contact: csi@med.unc.edu
Website: https://www.med.unc.edu/psych/csi/
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.
PI: Dr. Gabriel Dichter
Study Coordinator: Dr. Jessica Kinard (jessica.kinard@cidd.unc.edu) or 919-533-9305
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.
PI: Dr. Karen Bluth
Study Coordinator: Dr. Melissa Clepper-Faith (mscteens@unc.edu) or 919-966-0537
Assess the ability of osanetant, a best-in-class neurokinin-3 antagonist, to prevent Post-Traumatic Stress Disorder (PTSD) and Acute Stress Reaction (ASR) symptoms and prevent neurocognitive decline in civilian trauma survivors recruited in the immediate aftermath of motor vehicle collision who have acute ASR symptoms and who are at high risk of continued symptoms. Participants will take a series of neurocognitive assessments and surveys over a 12 week period to measure ASR symptoms and neurocogntive speed to assess Osantetants ability to prevent PTSD and ASR symptoms.
Participants will be assigned to 1-of-3 treatment arms: placebo, 100 mg osanetant, or 200 mg osanetant. All study personnel, besides an unblinded study statistician, will be blinded and will not know what treatment arm participants are being placed into. Participants will also be asked to completed a follow up ECG at 1 week and follow up blood draw 2 weeks after study drug as been started. Participation lasts 12 weeks in which online neurocogntive and survey assessments will be administered via a web-based link, participants will only need to report in person (mobile blood draw and ECG possible) for 1 week ECG and 2 week blood draw follow ups.
Who is eligible?
• Participants must be ≥ 18 years and ≤ 65 years of age, Admitted to ED within 24 hours of motor vehicle collision and anticipated to be discharged to home from the emergency department.
• Males with female partners of childbearing potential agree to use a highly effective method (<1% failure rate; ie, double-barrier-method) of contraception from screening through check-out.
• Females of childbearing potential agree to use a highly effective method (<1% failure rate; ie, double-barrier-method) of contraception from screening through check-out.
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Smartphone with continuous service for 1 year
• Able to speak and read English
• PTS prediction tool risk score ≥ 16 in the ED
• Pain severity in the ED ≥ 4 (0-10 numeric rating scale
PI: Samuel McLean
Study Coordinators: Allison Britt (allison_britt@med.unc.edu) and Christine Bizgu (christine_bizgu@med.unc.edu)
Depressive Disorders Trials
In this study, we want to learn if a new device that delivers weak electricity to the scalp can reduce symptoms of depression. This current study uses stimulation that is personalized for each participant. All participants receive this new form of stimulation and there is no placebo or inactive group.
Who is eligible?
• Age: 18
• Major Depressive Disorder with current symptoms
What will be asked of you?
• One remote screening session (45 min)
• 5 consecutive days of stimulation (90 min per visit)
• Online surveys (20 min)
• Two week follow-up (45 min)
Participants receive up to $300 in compensation for completing all study visits. Free parking is provided.
Contact Information:
PI: Dr. David Rubinow
Study Coordinator: Tobias Schwippel (tobias_schwippel@unc.edu)
Website: https://redcap.link/CLACSStudy
In this study, we record electrical activity and functional MRI data from the brain during a computer task. We also deliver transcranial alternating current stimulation (tACS) to understand how stimulation affects decision-making in patients with Major Depressive Disorder (MDD). IRB #21-1321
Who is eligible?
• Ages 18-65
• Current diagnosis of Major Depressive Disorder
What will you receive?
• Up to $120
• Convenient parking at study site
What will be asked of you?
This is a brief study that requires a virtual session, a tACS session, and an MRI session. The total time spend in this study will be 6.5 hours. If you qualify for the study after the virtual session, then you will meet us at the Carolina Center for Neurostimulation at Vilcom Center Drive for your stimulation and EEG recording session. The MRI session is optional and takes place at Marsico Hall on UNC Chapel Hill campus.
If you are interested, then please reach out to the study coordinator of this study, Paul Edwards, to schedule your phone screening.
This study uses a specific type of non-invasive brain stimulation known as transcranial alternating current stimulation (tACS) to determine its effects on brain activity and mood in patients with Major Depressive Disorder (MDD). IRB 20-1822.
Who is eligible?
• Ages 18-65
• Current diagnosis of major depressive disorder
What will you receive?
• Up to $255
• Convenient parking at study site
What will be asked of you?
There will be two online or phone appointments that involve answering questions about your mental health history. They may vary given the duration of your history but should take less than 4 hours in total. If you qualify for the study, we will schedule 5 consecutive visits to the Carolina Center for Neurostimulation at Vilcom Center Drive for your stimulation and EEG recording sessions. The final visit will be two weeks after your final day of stimulation.
Interested?
Fill in this brief questionnaire and our study team will be in contact to discuss if this study is a good fit for you.
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
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)
• Is 14 – 19 years of age
• Has regular menstrual cycles
• Has experienced significant life stress OR experiences depression, hopelessness, sadness, or worry
• Teens who have suicidal thoughts or engage in self-harm
Then they may be eligible to participate in a research study that seeks to understand the influence of the menstrual cycle and associated hormones on female teens’ stress responses and mood symptoms.
For participation in the study, we will ask you and your teen to come for an initial visit involving interviews and questionnaires. Following the interview visit, your teen would then come in for two lab visits, during which they will watch a video, engage in a mental task, and provide saliva samples and dried blood spots (via finger prick) before and after the mental task. In addition to the in-person visits, we will ask your child to complete daily and weekly surveys via a smartphone and to provide urine samples via home urine test strips.
Your child may earn up to $570 for participation in this study.
Contact our study team at:
Email: teencyclestudy@unc.edu
Phone: 1-984-999-0783
Website: https://uncteencycle.wordpress.com
Email Address: teencyclestudy@unc.edu
Development Disorders Trials
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.
PI: Dr. Laura Klinger and Dr. Brianne Tomaszewski
Eating Disorders Trials
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.
Psychosis Trials
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
Contact Information: PI: Dr. Diana Perkins Study Coordinator: Jennifer Nieri, LCSW (jennifer_nieri@med.unc.edu) or 877-774-6319
Post-Traumatic Stress Disorder (PTSD) Trials
Currently, no secondary preventative interventions are available to prevent PTSD in high risk individuals after trauma. The WISE pilot trial will assess the ability of Written Exposure Therapy (a low cost, evidence based intervention that has been demonstrated to treat chronic PTSD symptoms) to reduce the incidence and severity of PTSD when delivered via telehealth after motor vehicle collision. The trial will randomize 40 individuals who present to a study ED for care after MVC to five sessions of written exposure therapy vs. unemotional writing control.
The trial will randomize 40 individuals to five sessions of written exposure therapy vs. unemotional writing control. Both exposure and control interventions will be administered via telehealth (n=40), with 20 individuals receiving written exposure therapy and 20 receiving unemotional writing intervention. Participants will be assessed via traditional self-report surveys at baseline, 4 weeks, 8 weeks, and 3 months.
A convenience sample of patients presenting to the emergency department for care will be assessed for eligibility. Patients will be eligible to participate if they: are alert and oriented at the time of screening, English speaking (written and spoken), at least 18 years of age, present to the ED within 72 hours of MVC, would be discharged home after ED evaluation, have an email address and mailing address, have an iOS or Android-compatible smartphone without loss of cellular connection due to inability to pay bill for 1 year, and be willing to participate in remote therapy sessions. Participants must also demonstrate willingness to complete outlined study treatments and activities.
Contact Information:
PI: Dr. Samuel McLean
Study contact: Lindsay Macchio (lindsay_machio@med.unc.edu)
Schizophrenia Trials
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
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
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
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
Substance Use and Addiction Trials
For more information please visit: studies.unc.edu/21-1548
Contact Information:
PI: Dr. Christian Hendershot
Study Coordinator: Lily Al-Omari (barlab@unc.edu) or 919-962-3069
For more information please visit: studies.unc.edu/21-1689
Contact Information:
PI: Dr. Christian Hendershot
Study Coordinator: Lily Al-Omari (barlab@unc.edu) or 919-962-3069
Tardive Dyskinesia Trials
Patients presenting to the ED within 24 hours of MVC (n=90, 45 non-Hispanic Black, and 45 non-Hispanic White) will receive a single dose of study drug prior to ED discharge. Prior to study drug administration, a baseline assessment will be performed, and a fingerstick blood sample will be obtained to evaluate 25-hydroxyvitamin D level. At 3 months, participants will also perform fingerstick blood collection at home and mail to the study team to enable assessment of 3 month 25-hydroxyvitamin D concentration by treatment group. Throughout the entire 3-month period, six self-report online surveys will be completed by participants, assessing and monitoring mental health, physical health, pain, substance use, and satisfaction.
Inclusion criteria include between the ages of 18 and 65, admission to the ED within 24 hours of MVC, plan to be discharged home, willingness to comply with study procedures, has a smartphone with continuous service greater than 1 year, able to speak and read English, alert and oriented, willing to take study drug, non-Hispanic White or non-Hispanic Black, point of care Vitamin D level of less than 100 ng/ml, ED admission pain severity of 4 or higher.
Contact Information:
PI: Dr. Samuel McLean
Study Coordinator: Sadie Kee (sadie_kee@med.unc.edu) or (804)873-0903
Website: https://www.med.unc.edu/itr
Trauma and Physical Health
For more information please visit: studies.unc.edu/21-1548
Contact Information:
PI: Dr. Christian Hendershot
Study Coordinator: Lily Al-Omari (barlab@unc.edu) or 919-962-3069
Women’s Mood Disorders Trials
Pregnancy and childbirth are times of joy and excitement for many expecting mothers, but they can also become times of stress and worry, presenting with the onset or worsening of obsessional thoughts, compulsive rituals, depression, and anxiety during and even after pregnancy. These symptoms can have severe manifestations and implications for the health of the mother and baby, thus there is an urgent need for greater precision with diagnosis and treatment of perinatal OCD and depression.
The UNC Center for Women’s Mood Disorders wants to learn more about mood and brain function during the menopause transition. During this big life change, many women feel and behave differently because of the changes that are happening inside their bodies. We want to find ways to help women feel better during this time. We also want to help them understand the reasons for the change in emotions and different thoughts they might be having. This research study will look at a patch that is already FDA approved for improving bone density and managing hot flashes (called Climara) to see if it can also improve thoughts, feelings, and the ability to focus in women who are going through this change.
This study involves 6 visits, up to 4 of these can be done virtually on Zoom and 2 of these will be done at UNC. We will ask you to take a form of estrogen for three weeks, sit for 2 scans of your brain, and speak regularly with our study team about your thoughts and feelings. Before starting any medication, you would answer questions about your mood and health, and receive a physical exam.
You may be eligible to participate in this study if you are between the ages 44-55, have skipped at least two periods in the past year, but you’ve still had a period in the last year, and are feeling less interested in your usual activities.
Study Screening Form: www.PEEPstudy.com
Contact Information:
PI: Dr. Gabriel Dichter
Study Coordinator: Kate Gibson (kathryn_gibson@med.unc.edu) or 919-966-5243