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Behavioral Health 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.

Contact Information:
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.

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

Depressive Disorders Trials

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.

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
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)
If your biologically female child:
•  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.

For more information, please contact:
PI: Dr. Laura Klinger and Dr. Brianne Tomaszewski
Contact the TSTEP team at 919-966-4684 or at TEACCH_Research@med.unc.edu

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

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
Contact Information:
PI: Dr. Diana Perkins
Study Coordinator: Jennifer Nieri, LCSW (jennifer_nieri@med.unc.edu) or  877-774-6319

Schizophrenia Trials

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
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
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

Substance Use and Addiction Trials

Researchers at UNC-Chapel Hill are conducting a study to examine the effects of an approved weight loss medication among adults who smoke cigarettes. Participants will be asked to take study medication at weekly visits to UNC. Some visits will involve cigarette smoking. Participants must be able to attend clinic appointments at least once per week. This is not a treatment study.

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

Researchers at UNC-Chapel Hill are conducting a study to examine the effects of an approved weight loss medication among adults who drink alcohol and smoke cigarettes. Participants will be asked to take study medication at weekly visits to UNC. Some visits will involve alcohol consumption. Participants must be able to attend clinic appointments at least once per week. This is not a treatment study.

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

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

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.

Help our research team at UNC to improve pregnancy and childbirth for expecting mothers by enrolling in the Mom2Be Study and filling out our study screener (go.unc.edu/mom2be)!

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
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