Department of Psychiatry Clinical Trials

The goal of this clinical trial is to learn if Transcranial Magnetic Stimulation (TMS) to part of the brain called the ventromedial prefrontal cortex (VMPFC) can treat a symptom called rumination in adults with major depression that has not responded to at least one medication trial. The main questions it aims to answer are: Does TMS to the VMPFC change brain activity on functional magnetic resonance imaging (fMRI) during a negative self-referential processing task in adults with depression? Does TMS to the VMPFC affect rumination in adults with depression? 

Researchers will compare brain scans and rumination scores before, during, and immediately after TMS.

You may be eligible if you are ages 18 to 70 with a diagnosis of unipolar major depressive disorder without psychotic features by the Mini-International Neuropsychiatric Interview (MINI), and do not have a history of significant substance use disorder within the past six months.

All IN for Health information.

For more information, email psycrsch@iu.edu or call (317)214-0333. 

Faculty: Susan Conroy, MD, PhD

The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.

You may be eligible if you are ages 22 to 70 with a diagnosis of non-psychotic unipolar major depressive disorder, and are not pregnant or plan to become pregnant during study.

For more information, email psycrsch@iu.edu. 

Faculty: Susan Conroy, MD, PhD

This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms.

The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and a follow-up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.

For more information, email psycrsch@iu.edu or call (317)601-8641.

Interested participants can complete this pre-screening questionnaire.

Faculty: Steve Strakowski, MD

Many individuals who experience extremely stressful or traumatic events may feel irritable or on edge, have unpleasant memories of the event that they try to avoid, and feel more distant from others. Narrative Exposure Therapy (NET) is a treatment that can help, particularly pregnant and postpartum women who have gone through very stressful or traumatic experiences. In NET, women talk through their life stories with a therapist to process stress and emotional pain. We are especially focusing on supporting Black women and women living in rural areas who may have faced difficult challenges. The goal of our study is to help participants learn (and practice) new ways to cope with these difficulties during an important time in their lives.

All study tasks can be completed virtually (online and via webcam). There is no transportation required to participate. 

You may be eligible if you are 18 years of age or older with a diagnosis of probable PTSD and are pregnant or postpartum (delivered within 16 weeks) at the time of the eligibility screening.
For more information, email psycrsch@iu.edu. 

Faculty: Michelle Miller, PhD

The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome. 

You may be eligible if you are ages 35 to 85 with a diagnosis of prodromal Alzheimer’s disease.

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For more information, email psycrsch@iu.edu or call (463)201-4992. 

Faculty: Jill Fodstad, PhD

The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial-ready cohort, and up to 550 participants in total, including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression.

You may be eligible if you are ages 25 to 55 with a diagnosis of Down syndrome and are able to complete an MRI procedure.

For more information, email psycrsch@iu.edu or call (463)201-4992.

Faculty: Jill Fodstad, PhD

The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone.

The maximum potential duration of study participation for a participant in Part A is approximately 144 weeks, and the maximum potential duration of study participation for a participant in Part B is approximately 116 weeks. The actual duration will vary for each participant depending on the time of enrollment and the overall rate of study enrollment.

You may be eligible if you are ages 18 to 75 with a current mild, moderate or severe opioid use disorder and do not have a lifetime history or current diagnosis of the following: schizophrenia or other psychotic disorder, bipolar disorder, borderline personality disorder or any eating disorder. For more information, email psycrsch@iu.edu or call (317)601-8641.

Faculty: Michael Bushey, MD, PhD

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. 

You may be eligible if you are ages 18 to 60 and have abstained from alcohol use between 14 days and one year, and do not have an unstable medical disorder.

For more information, email psycrsch@iu.edu. 

Faculty: Brandon Oberlin, PhD

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering stimulant use disorder (SUD) persons.  

You may be eligible if you are 18 years and older and have abstained from alcohol use between 14 days and one year, and do not have an unstable medical disorder. 

For more information, email psycrsch@iu.edu.  

Faculty: Brandon Oberlin, PhD 

This is a study to examine the efficacy of guanfacine extended release (GXR) compared with placebo in reducing drinking in men and women with Alcohol Use Disorder (AUD). The study will be conducted across two sites for 12-weeks. Indiana University will be the primary site, and Rutgers University, the secondary site. Participants at both sites will be randomized to either GXR or placebo, and titrated to full dose over a three-week period. After remaining at full dose for seven weeks, a two-week schedule will be used to taper participants off the medication. During the study, the investigators will collect brief reports throughout the day and evening of drinking severity, stress, craving, mood, arousal, anxiety, and emotion regulation at weeks one and two (baseline) and weeks five and six (steady state). Additionally, blood alcohol concentration levels will be collected three times per day for the full 12-weeks. Daily encrypted video recordings will be used to monitor medication compliance, and participants will also take part in twice weekly remote visits to assess safety, vitals, collect urine, monitor alcohol use, and receive weekly Medical Management. It is anticipated that guanfacine will demonstrate greater efficacy in women compared to men with AUD.

You may be eligible if you are 18 years and older and meet criteria for moderate to severe AUD, and do not meet criteria for moderate to severe substance use disorder, excluding alcohol and nicotine.

For more information, email psycrsch@iu.edu. 

Faculty: Helen Fox, PhD

The primary objective of this study is to evaluate the efficacy of extended-release naltrexone plus bupropion XL compared to matched injectable and oral placebo in reducing methamphetamine use in individuals with moderate or severe methamphetamine use disorder seeking to stop or reduce methamphetamine use.

You may be eligible if you are ages 18 to 65 with an interest in reducing or stopping methamphetamine use, and do not have an acute medical or psychiatric disorder that would, in the judgment of the study medical clinician, make participation difficult or unsafe.

For more information, email psycrsch@iu.edu. 

Faculty: Leslie Hulvershorn, MD and Olawale Ojo, MD

The primary objective of this study is to evaluate whether electrical stimulation can help reduce nicotine use in users who are nicotine dependent and/or vape at least 15 mg of nicotine per day.

You may be eligible if you are ages 21 to 50 and are not currently in or seeking treatment for nicotine use.

Connect with the study team.

Faculty: Joshua Brown, PhD and Leslie Hulvershorn, MD

This study is testing whether brain activity related to learning can help predict how well teens respond to a treatment program designed to reduce cannabis use. Teens ages 14-17 will complete a brain scan and then take part in 10 weekly virtual sessions where they report cannabis use and complete drug tests at home. Participants can earn prizes for staying cannabis-free. 

Eligible participants are ages 14 to 17 years who are MRI-eligible, and do not have a history of Fetal Alcohol Spectrum Disorder, intellectual disorders, pervasive development disorder or autism spectrum disorder, psychotic disorders, history of neurological problems (epilepsy, traumatic brain injury, brain tumor, cerebrovascular disease) by parent/guardian report. 

For more information, email psycrsch@iu.edu.  

Faculty: Joey Aloi, MD, PhD 

The primary objective of this study is to compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine. This is a phase 3, randomized, double-blind, 52-week study. 

Eligible participants are ages 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, and do not have a history of seizure disorder. 

For more information, email psycrsch@iu.edu.  

Faculty: Leslie Hulvershorn, MD