Northwestern University Feinberg School of Medicine
Department of Psychiatry & Behavioral Sciences
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Clinical Trials & Behavioral Studies

The Department of Psychiatry and Behavioral Sciences welcomes research participants ages 12 to 70 to enroll in studies aimed at improving the diagnosis and treatment of schizophrenia, bipolar disorder, Alzheimer’s disease, depression and anxiety. Browse the entries below and call the associated telephone numbers to learn how you can volunteer to help advance our understanding of psychiatric illness.

If you have questions, please call the Clinical Research Program office at 312-503-9100.

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Trials
Department of Psychiatry and Behavioral Sciences Research Registry
Northwestern University Department of Psychiatry and Behavioral Sciences seeks to develop a research registry database compiled of individuals who are interested in participating in research studies. The database would utilize potenti…
Northwestern University Department of Psychiatry and Behavioral Sciences seeks to develop a research registry database compiled of individuals who are interested in participating in research studies. The database would utilize potential research participants who view the Department’s website. This application is not in itself a research project, but only for the establishment of the registry for recruitment. Recruitment will be for studies that have been approved by the Northwestern University Institutional Review Board. Advertising for the research database will be posted on the Department’s website. Our aim is to recruit psychiatric patients, their family members, and healthy controls for research on mood disorders, schizophrenia, and Alzheimer's disease.
Goldman, Morris BGoldman, Morris B
STU00034881
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Jain, Ankit +1 312 503 9092
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Northwestern University The Department of Psychiatry and Behavioral Sciences, Clinical Research Program (NU CRP) Recruitment Pipeline
The recruitment pipeline provides research staff with an organized system of identifying researchsubjects.NU CRP clinical research studies covers a wide spectrum of Ax…
The recruitment pipeline provides research staff with an organized system of identifying researchsubjects.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 recruitmentregistry 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
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Jain, Ankit +1 312 503 9092
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A Randomized Open-Label Pilot Trial to Evaluate the Safety and Efficacy of 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 …
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
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Fairchild, Melody Dawn 312 503 7071
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Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients
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 …
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
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Fairchild, Melody Dawn +1 312 503 7071
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Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women with Bipolar Disorder
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 o…
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
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1-855-NU-STUDY
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NEUROLOGICAL MECHANISMS OF TREATMENT PROJECT (NMT): AN EXAMINATION OF THE NEUROLOGICAL EFFECTS OF COGNITIVE BEHAVIORAL THERAPY ON ADOLESCENTS WITH DEPRESSION
The purpose of this study is to see if Cognitive Behavioral Therapy changes the way the brains of adolescents with depression process informati…
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
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O'Dor, Sarah 312 503 1802
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Behavioral activation and varenicline for smoking cessation in 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) Beh…
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
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Reyes, Celine 1 877 236 7487
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Testing the ability of JNJ-18038683, a selective serotonin (5-HT)7 antagonist, to improve cognition and reduce residual depressive symptoms in stable bipolar patients
This study is being conducted in order to determine if an investigational drug, JNJ-18038683, improves mental function and is safe in …
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
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Nikolajuk, Katie M 312 503 9076
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Optimizing Medication Management for Mothers with Depression (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

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 because a decrease in the blood level of the

drug may result in the antidepressant becoming ineffective and an increase in mood symptoms or recurrence of

depression may occur. An increase in antidepressant concentration may lead to side effects. We aim to better

understand the course of these changes across pregnancy and postpartum and determine how n woman’s genetic

makeup affects these changes. Our overall goal is to develop guidelines to optimize antidepressant treatment of

pregnant women.

Pregnant women ages 18-45 years old less than 18 weeks pregnant with a singleton pregnancy taking sertraline (Zoloft), fluoxetine (Prozac), escitalopram (Lexapro), or citalopram (Celexa) and plan to continue this medication throughout pregnancy and through the first 4 months postpartum. 
Wisner, KatherineWisner, Katherine
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00201386
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Fatima, Syeda
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Role Functioning Changes in New Onset Symptoms
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 …
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
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Jain, Ankit 312 503 9092
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LiveWell: A Mobile Intervention for Bipolar Disorder
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 …
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
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Jonathan, Geneva 1 312 503 9095
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A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder Who are Early in Their Illness
This is a study to evaluate the effect of the investigational drug compared to Olanzapine on body Weight in youn…
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
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Jain, Ankit 312 503 9092
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Augmentation versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders with Treatment Resistant Depression (ASCERTAIN-TRD)
We are asking you to take part in this research study because you have major depressive disorder and you have tried an antidepressa…
We are asking you to take part in this research study because you have major depressive disorder and you have tried an antidepressant in the past that has not helped your depression. Also, you have not had a satisfactory response from your current antidepressant medication. 

We expect that you will be in this research study for up to 12 weeks and we will ask you to make 7 study visits to Northwestern University.  

1. women and men ages 18-80,with major depressive disorder

2. You have tried an antidepressant but less than 50% of the symptoms have resolved 

Dokucu, Mehmet EDokucu, Mehmet E
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT02977299 STU00207732
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Jain, Ankit +1 312 503 9092
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xIRB Escitalopram for Agitation in Alzheimer’s Disease (S-CitAD)

This study is designed to examine the efficacy and safety of escitalopram as treatment for agitation in Alzheimer's dementia (AD) patients. Participants with clinically significant agitation, and their caregiver(s), will receive a …

This study is designed to examine the efficacy and safety of escitalopram as treatment for agitation in Alzheimer's dementia (AD) patients. Participants with clinically significant agitation, and their caregiver(s), will receive a structured psychosocial intervention. Participants not showing a response three weeks later will be randomized 1:1 to escitalopram (up to 15 mg/day) or a matching placebo. Participants will receive study drug for 12 weeks, with in-person visits at weeks 3, 6, 9, and 12, and with telephone contacts between in-person visits. Following the 12-week study treatment period, participants will be followed for another 12 weeks without receiving study drug. Participants who do show a response to the psychosocial intervention will not be randomized to study drug but will be followed for the 24-week follow-up period.

Alzheimer's dementia diagnosed clinically

Availability of a caregiver who spends at least several hours per week with the participant

Schrift, MichaelSchrift, Michael
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03108846 STU00208986
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Jain, Ankit +1 312 503 9092
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BP40283 -Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Effects of RO6889450 in Patients with Schizophrenia or Schizoaffective Disorder and Negative Symptoms

The purpose of this study is to find out what effects, good or bad, the study medication RO6889450, has on you a…

The purpose of this study is to find out what effects, good or bad, the study medication RO6889450, has on you and symptoms of your schizophrenia or schizoaffective disorder.

 

You were selected as a possible participant in this study because you have been diagnosed with schizophrenia or schizoaffective disorder and negative symptoms (thoughts, feelings, or behaviors normally present that are absent or diminished in people with schizophrenia or schizoaffective disorder)

 

This study is intended to contribute to the further development of the study medication. The study medication is still being tested and has not been approved by any national health authority, including the US Food and Drug Administration (FDA).

You havebeen diagnosed with schizophrenia or schizoaffective disorder and negative symptoms(thoughts, feelings, orbehaviors normally present that are absent or diminished in people with schizophreniaor schizoaffective disorder)

 

Rado, JeffreyRado, Jeffrey
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03108846 STU00209192
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Jain, Ankit +1 312 503 9092
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