Northwestern University Feinberg School of Medicine

Department of Psychiatry and Behavioral Sciences

Clinical Trials and Behavioral Studies

The Department of Psychiatry and Behavioral Sciences welcomes research participant’s from 12 to 70 years old to enroll in studies aimed at improving the diagnosis and treatment of schizophrenia, bipolar disorder, Alzheimer’s disease, depression, and anxiety.

We strive to reach out into the community in which we work to improve the public’s understanding of psychiatric illness, and to reduce the stigma that has been associated with mental illness in the past.

Each research group listed has multiple studies for you or a family member and you will be paid for your time.  Please call the telephone numbers listed below to learn how you can volunteer to be a research participant and help advance our understanding of psychiatric illness.

Clinical Research Program

The Clinical Research Program within the department helps Principle Investigators (PIs) and participants navigate the clinical research process. Learn more about our services, space, and meet our team.

Active Trials and Studies

Our current active protocols are listed below. If you have any questions about the particular study protocol, please contact the study coordinator.  

For general information about our research or participation, please call the Clinical Research Program office at 312-503-9100.

Trials
NU CRP Recruitment Pipeline
The recruitment pipeline provides research staff with an organized system of identifying research subjects.NU CRP clinical research studies covers a wide spectrum of Axis I Diagnoses such as schizophrenia, depression, anxiety, etc. NU CRP also conducts research studies fo…
The recruitment pipeline provides research staff with an organized system of identifying research subjects.NU CRP clinical research studies covers a wide spectrum of Axis I Diagnoses such as schizophrenia, depression, anxiety, etc. NU CRP also conducts research studies for patients who are diagnosed with certain neurological diseases such as Alzheimer’s disease, Tourette’s Syndrome, etc. NU CRP conducts basic, translational and clinical research. Personal Health Information (PHI) will not be collected. All information collected in this recruitment registry is based on the patient self-report. You will be contacted to answer additional questions by someone in the study staff and to determine your eligibility for the current studies.
Goldman, Morris BGoldman, Morris B
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
STU00059328
More Info

For more information on this study please contact us:

312 503 9100
Repetitive Transcranial Magnetic Stimulation in Cancer Patients with Depression and Anxiety
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well these two methods of rTMS work in treating cancer-related depression. You a…
The primary goals of this study are to determine if rTMS is safe and tolerable in depressed cancer patients and to determine how well these two methods of rTMS work in treating cancer-related depression. You are being asked to take part in this study because you are a cancer patient in remission who is depressed currently. In the future, we hope to be able to use rTMS on depressed cancer patients who are actively receiving cancer treatment. However, since this is a preliminary study, we will only include patients in remission. Finally, anxiety often accompanies depression. So, we are also interested in understanding your current level of anxiety and how rTMS affects any anxiety that you might have. Your participation in this study will last for approximately seven weeks and will involve 31 visits.
Dokucu, Mehmet EDokucu, Mehmet E
NCT01701284 STU00063218
More Info

For more information on this study please contact us:

Fairchild, Melody Dawn 312 503 7071
HippoPCI
The purpose of this study is to improve our understanding of differences in size, shape and activity of a variety of brain areas that can occur in women with breast cancer undergoing adjuvant chemotherapy or hormonal therapy, and how these brain areas are related to the development of mild c…
The purpose of this study is to improve our understanding of differences in size, shape and activity of a variety of brain areas that can occur in women with breast cancer undergoing adjuvant chemotherapy or hormonal therapy, and how these brain areas are related to the development of mild cognitive impairment as the results of these treatments. This study involves obtaining pictures of the brain’s size, shape and activity using a Magnetic Resonance Imaging (MRI) device, a machine that uses a powerful magnet to obtain this information without using any radiation. This procedure has been used safely with humans in many different studies. Your part in this study will last for 1 to 2 years.
Female breast cancer patients between 40-70 years old
Wang, LeiWang, Lei
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT01949376 STU00069634
More Info

For more information on this study please contact us:

Berger, Jessica M 312 503 4995
PK-LAPB
This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during pregnancy for women with Bipolar Disorder. The investigators predict that the concentration of Lamictal in women's blood will decrease during pregnancy, and increase after …
This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during pregnancy for women with Bipolar Disorder. The investigators predict that the concentration of Lamictal in women's blood will decrease during pregnancy, and increase after postpartum. Because the concentration of the medication is likely to decrease during pregnancy, it is important for doctors to know how much they should increase a patient's dose in order to prevent worsening of Bipolar symptoms. In this study, the investigators will ask that participants complete up to five overnight visits to our clinical research unit where their blood will be drawn every couple of hours, through an IV catheter, to measure how the concentration of lamotrigine (Lamictal) changes over time. Participants will be compensated for their time.
Clark, CrystalClark, Crystal
NCT01996293 STU00079810
More Info

For more information on this study please contact us:

1-888-NU-STUDY
NEUROLOGICAL MECHANISMS OF TREATMENT PROJECT (NMT):
The purpose of this study is to see if Cognitive Behavioral Therapy changes the way the brains of adolescents with depression process information. We hope to determine if adolescents with depression who have received treatment process information th…
The purpose of this study is to see if Cognitive Behavioral Therapy changes the way the brains of adolescents with depression process information. We hope to determine if adolescents with depression who have received treatment process information the way adolescents without depression react. Your child is being asked to participate in this study because he/she is age of 13-17 and has been diagnosed of Major Depressive Disorder (MDD). You or your child will be asked to complete 3 assessment days, including today, and 12 weeks of individual Cognitive Behavioral Therapy (CBT). During the assessment days, your child will be asked to complete questionnaires regarding how he/she is feeling and how he/she copes with stressful situations.
13-17 years old, diagnosed with Major Depressive Disorder
Breiter, HansBreiter, Hans
STU00081474
More Info

For more information on this study please contact us:

O'Dor, Sarah 312 503 1802
Behavioral activation and varenicline with depressed smokers
The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Behavioral activation f…
The goal of this study is to develop a new combined treatment to help individuals with clinical depression to quit smoking. Participants will receive one of four treatments: 1) Standard behavior therapy + placebo; 2) Behavioral activation for smoking cessation + placebo; 3) Standard behavior therapy + varenicline (Chantix); or 4) Behavioral activation for smoking cessation + varenicline (Chantix).
1. Adult (18 years of age or older) daily cigarette smokers (1+ cigarettes per day)
2. Lifetime history of clinical depression (Major Depressive Disorder)
Hitsman, Brian LHitsman, Brian L
NCT02378714 STU00100303
More Info

For more information on this study please contact us:

Reyes, Celine 1 877 236 7487
JNJ-18038683
This study is being conducted in order to determine if an investigational drug, JNJ-18038683, improves mental function and is safe in people who have bipolar disorder and are taking other medications for their illness. Mental function is how your brain works and includes your mood, memo…
This study is being conducted in order to determine if an investigational drug, JNJ-18038683, improves mental function and is safe in people who have bipolar disorder and are taking other medications for their illness. Mental function is how your brain works and includes your mood, memory and how you think and concentrate. An investigational drug is one that is not approved for sale by the US Food and Drug Administration (FDA) or any other regulatory or health agency. This study compares an experimental drug to a placebo. A placebo is an inactive substance made to look/taste like an active medicine. We expect that you will be in this research study for up to 10 weeks, including the screening period.
Adults 18 to 60 years old with diagnosis of of bipolar disorder
Meltzer, HerbertMeltzer, Herbert
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT02466685 STU00200919
More Info

For more information on this study please contact us:

Nikolajuk, Katie M 312 503 9076
OPTI-MOM
The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body fluid) during pregnancy and postpartum. Taking the same medication dose …
The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body fluid) during pregnancy and postpartum. Taking the same medication dose when you are pregnant may result in an amount of drug in your blood that is different than when you are not pregnant. We will also study the impact of genetic factors on the amount of drug in your blood. Drug metabolism (how medications are broken down, absorbed, and removed from the body) differs among people because of their unique genetic make-up, which can cause medications to be metabolized faster or slower. This means that when two people with different genetic backgrounds take the same dose, the concentration of the medicine in their blood can vary dramatically. . Changes in antidepressant concentrations are important to monitor, as decreases in drug levels may cause the antidepressant to become ineffective and result in an increase in mood symptoms or recurrence of depressive episodes. Increases in antidepressant concentration may lead to increased side effects. We are hoping to better understand the course of these changes across pregnancy and postpartum and how an individual’s genetic makeup impacts these changes. Our overall goal is to develop guidelines to optimize antidepressant treatment of pregnant women
Are 18 years of age or older
Are currently at or less than 18 weeks pregnant
Speak English or Spanish
Have received a diagnosis of depression
Take sertraline (Zoloft), fluoxetine (Prozac), citalopram (Celexa), or escitalopram (Lexapro) and plan to continue it during pregnancy and postpartum
Wisner, KatherineWisner, Katherine
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT02519790 STU00201386
More Info

For more information on this study please contact us:

O'Shea, Kelly 312 695 6076
Role Functioning Changes NOS
Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning. During this study the investigators will 1) collect measure…
Patients between 18 and 26 who arrive seeing treatment for new-onset mental health symptoms. They will receive treatment as usual, while being assessed overt he course of one year for changes in role functioning. During this study the investigators will 1) collect measures of social cognition and social functioning in adolescents and young adults who are experiencing early symptoms of a major mental disorder; and 2) evaluate the predictive value and utility of a new role functioning assessment measure for individuals experiencing changes in their lives after an index episode of mental illness. The primary outcome of the study is to correlate Role Functioning Rating Scale (RFRS), clinical symptoms, and social cognition. The early symptoms of major mental disorders, such as bipolar disorder and schizophrenia, can be non-specific, attenuated, or intermittent. These symptoms nevertheless frequently interfere with an individuals' ability to effectively carry-out multiple aspects of their everyday lives, including social, vocational, and educational functioning. Functional changes may in fact occur before individual symptoms reach the threshold for clinical significance. Relying solely on the emergence of early symptoms of psychopathology can delay treatment or lead to the improper selection of treatments that are not effective. Therefore, measuring changes in real-world functioning that correlate with or predate symptoms may be a useful tool for developing an effective treatment plan. While psychopharmacology and psychotherapy can improve some symptoms of severe mental illness, much less is known about the mechanisms for improving impairments in social cognition. Importantly social cognition affects not just social functioning, but many critical aspects of real-world functioning. Thus, advancing our understanding of how social cognition and real-world functioning change over time, and their association to changing clinical symptoms, will help improve our understanding of early mental illness, and should inform patient care in new ways. Currently, there are only a limited number of tools available for assessing aspects of real-world functioning as they connect to social cognition. Therefore, the overarching goal of the present study is to conduct a pilot study to develop a new tool that measures functioning and evaluate the relationship between this new tool and measures of social cognition and symptoms.
Inclusion Criteria:

Age 18 to 26 years
Individuals seeking treatment for psychiatric symptoms in a clinical care setting
Able to provide informed consent (age 18-26)
Subjects must consent to a review of the medical records in order to track changes in clinical symptoms
Fluent in English
Exclusion Criteria:

Adults unable to consent
Individuals who have not reached the age of 18
Pregnant women
Prisoners.
Cronenwett, Will JCronenwett, Will J
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
STU00201133
More Info

For more information on this study please contact us:

Jain, Ankit 312 503 9092
PRELAPSE
Medications for the treatment of schizophrenia come in varied forms. Some are taken one or more times a day; other types are taken once every 2 or 4 weeks. The purpose of the PRELAPSE study is to compare standard treatment with treatment with a version of the medication aripiprazole that i…
Medications for the treatment of schizophrenia come in varied forms. Some are taken one or more times a day; other types are taken once every 2 or 4 weeks. The purpose of the PRELAPSE study is to compare standard treatment with treatment with a version of the medication aripiprazole that is taken only once each month. To allow the aripiprazole to be taken only once a month with current technology, the once monthly aripiprazole is given as an injection (sometimes called a “shot”). We expect that you will be in this research study for 24 months (two years). The study will last for approximately 3.If you choose to participate in the optional MRI sub-study, you will undergo up to 3 MRI sessions; one at the time of your baseline visit, a second that takes place coinciding with your Month 12 visit and a third at the Month 24 visit. Each appointment at the MRI facility should take approximately 1 hour.
Individuals with schizophrenia from 18 to 35 years old
Rado, JeffreyRado, Jeffrey
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT02360319 STU00201898
More Info

For more information on this study please contact us:

Jain, Ankit 312 503 9092
LW RCT
This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent relapse in people with bipolar disorder. If yo…
This study is being done to evaluate the use of a mobile phone intervention for bipolar disorder that aims to improve patient self-management and increase the effectiveness of psychological interventions. The goal is to reduce symptoms and prevent relapse in people with bipolar disorder. If you are eligible for the study, your participation will last up to 12 months.
Individuals 18-65 years old who have been diagnosed with bipolar disorder and are currently working with a psychiatrist
Goulding, EvanGoulding, Evan
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03088462 STU00202860
More Info

For more information on this study please contact us:

Jonathan, Geneva 1 312 503 9095
ALK3831-A307
This is a study to evaluate the effect of the investigational drug compared to Olanzapine on body Weight in young adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder who are Early in their Illness. Participation will last up to 20 weeks. Before starting the study, ea…
This is a study to evaluate the effect of the investigational drug compared to Olanzapine on body Weight in young adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder who are Early in their Illness. Participation will last up to 20 weeks. Before starting the study, each participant will be evaluated to determine his or her eligibility to participate. Each participant who qualifies will receive study-related tests, investigational medication and study-related care at no cost. Qualifying participants may be compensated for time and travel. If eligible, they will start the 12 week program where they are randomly assigned (like flipping a coin) to take one of two treatments. No one will know which type of treatment they are taking. During the 12 weeks, qualified participants will return for clinic visits where they will meet with the study doctor or staff and complete the following procedures: Interviews about symptoms, medical and psychiatric history, and general quality of life. Answer questions about the treatments they receive and how they are doing Measure their weight, blood pressure,

Ages Eligible for Study: 18 Years to 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Has less than 10 weeks previous treatment with antipsychotics (cumulative; lifetime)
Has less than 4 years elapse since the initial onset of active-phase of symptoms
Have a body mass index (BMI) of 18.0 to
Rado, JeffreyRado, Jeffrey
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03187769 STU00205116
More Info

For more information on this study please contact us:

Jain, Ankit 1 312 503 9092
(xIRB) ANEW
The purpose of this study is to assess the efficacy of the investigational medication Lu AF35700 in alleviating symptoms of schizophrenia in patients diagnosed with schizophrenia either ≤5 years or ≥10 years ago. Participation will last a total of 23 weeks including 3 weeks of screen…
The purpose of this study is to assess the efficacy of the investigational medication Lu AF35700 in alleviating symptoms of schizophrenia in patients diagnosed with schizophrenia either ≤5 years or ≥10 years ago. Participation will last a total of 23 weeks including 3 weeks of screening, 14 weeks of treatment, and a post-study follow-up 6 weeks after treatment. Patients will be invited to the clinic to discuss the study before deciding to participate. At the next visit patients will be evaluated for eligibility. If the patient is a good fit, they will be randomly assigned (like flipping a coin) to one of three treatments: Risperdal, Olanzapine, or Lu AF35700. During the study patients will meet with a study doctor, complete interviews about their medical and psychiatric history, discuss symptoms, and measure vital signs such as blood pressure and pulse. Patients will be compensated for time and travel and will receive all study-related tests, investigational medication and study-related care at no cost.
Men and women at least 18 years of age, diagnosed with schizophrenia either ≤5 years or ≥10 years ago. Patients should still be experiencing schizophrenia symptoms despite regularly taking medication. Patients should not be taking a mood stabilizer, and have a person in their life (friend, family member, caseworker) who would be available by phone to discuss the patients symptoms and involvement in the study.
Meltzer, HerbertMeltzer, Herbert
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT02717195 STU00206094
More Info

For more information on this study please contact us:

Nikolajuk, Katie M 312 503 9076