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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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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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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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Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women with Bipolar Disorder

We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of lamotrigine (Lamictal). Changes in the metabolism of lamotrigine have the potential to lead to less…

We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of lamotrigine (Lamictal). Changes in the metabolism of lamotrigine have the potential to lead to less than therapeutic drug levels, which may cause an increase in mood symptoms. Participating in this study may help researchers better understand how to adjust lamotrigine in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

Participation Involves:

  • 3 overnight visits during pregnancy and 2 postpartum,
  • expert evaluation, mood assessments, and blood draws, and
  • to compensate for your time and effort, you will receive between $100 and $150 for each completed overnight visit.

To qualify for this study you must be:

  • pregnancy planning or less than 27 weeks pregnant,
  • between the ages of 18 and 45, and
  • taking lamotrigine (Lamictal) and planning to continue to take it during pregnancy and postpartum.

Clark, Crystal TClark, Crystal T
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT01996293 STU00079810
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Lithium Therapy: Understanding Mothers, Mood and Metabolism
We are working to understand how physiological changes during pregnancy and postpartum affect lithium blood levels. Changes in metabolism have the potential to lead to high lithium levels that can lead to toxicity or less than therapeutic li…
We are working to understand how physiological changes during pregnancy and postpartum affect lithium blood levels. Changes in metabolism have the potential to lead to high lithium levels that can lead to toxicity or less than therapeutic lithium levels which may cause an increase in mood symptoms. Participating in this study will help researchers better understand how to adjust lithium dose in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

Participation involves one overnight visit per trimester and two postpartum. Each visit includes expert evaluation, mood assessments, and blood draws. To compensate for your time and effort you will be eligible to receive up to $750 for your participation in the study. Validation for on-site parking will be provided.

To qualify for this study you must be:

  • pregnancy planning or less than 27 weeks pregnant,
  • between the ages of 18 and 45, and
  • taking lithium (Lithium Carbonate) and plan to continue taking it during and after pregnancy.

Clark, Crystal TClark, Crystal T
  • Map it 676 N. St. Clair St.
    Chicago, IL
NCT02490241 STU00200026
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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, Herbert YMeltzer, Herbert Y
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT02466685 STU00200919
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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, Katherine LeahWisner, Katherine Leah
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00201386
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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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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, Evan HGoulding, Evan H
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03088462 STU00202860
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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 ( http://enlightenstudy.com/ ) to evaluate the effect of the investigational drug compared to Ol…
This is a study ( http://enlightenstudy.com/ ) 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, Jeffrey ThomasRado, Jeffrey Thomas
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03187769 STU00205116
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Pharmacokinetics of Risperidone and Similarly Metabolized Second Generation Antipsychotics Across Pregnancy
We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of mood-stabilizing medications, such as aripiprazole, lurasidone, quetiapine, and r…
We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of mood-stabilizing medications, such as aripiprazole, lurasidone, quetiapine, and risperidone. Changes in the metabolism of these medications have the potential to lead to less than therapeutic drug levels, which may cause an increase in mood symptoms. Participating in this study may help researchers better understand how to adjust mood-stabilizing medications in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

Participation Involves:

  • PK protocol: 2 overnight visits during pregnancy and 1 postpartum, plus one checkup postpartum.
  • CS protocol: 2 checkups during pregnancy and 2 checkups postpartum.
  • Each visit includes expert evaluation, mood assessments, and blood draws.
  • To compensate for your time and effort, you will receive $50 for each completed checkup and $200 for each completed overnight visit.

To qualify for this study you must be:

  • pregnancy planning or less than 22 weeks pregnant,
  • between the ages of 18 and 45, and
  • taking aripiprazole (Abilify), lurasidone (Latuda), quetiapine (Seroquel), or risperidone (Risperdal), and plan to continue taking it during and after pregnancy.
Clark, Crystal TClark, Crystal T
  • Map it 676 N. St. Clair St.
    Chicago, IL
STU00205640
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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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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 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)

Rado, Jeffrey ThomasRado, Jeffrey Thomas
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03108846 STU00209192
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A Phase 2, Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BIIB104 in Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
This is a study to look at how safe and effective the study drug is in people with CognitiveImpairment…
This is a study to look at how safe and effective the study drug is in people with CognitiveImpairment Associated with Schizophrenia (CIAS). CIAS refers to some issues that people withschizophrenia may have, including having trouble remembering things, learning new things, ormaking good decisions.
We are asking you to take part in this research study because you have schizophrenia and may be having trouble remembering things, learning new things, or making good decisions.
Rado, Jeffrey ThomasRado, Jeffrey Thomas
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT03745820 STU00210796
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A Single-Dose Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of LY3154207 in Healthy Subjects

Earn $25/hour for completing the following components:

  • 1 screening visit (about 4 hours)
  • 2 study visits (about 8 hours each)
  • 1 phone call (about 10 …

Earn $25/hour for completing the following components:

  • 1 screening visit (about 4 hours)
  • 2 study visits (about 8 hours each)
  • 1 phone call (about 10 minutes)

You can get paid approximately $400-$500 for completing this study, and you will be reimbursed for parking or public transportation costs.

For more information, please call the research coordinator at 312-503-5235 or email samuel.yoo@northwestern.edu.

Investigator: James Reilly, PhD

NU IRB: STU00211277

Study Title: A Single-Dose Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of LY3154207 in Healthy Subjects

  • 18-40 years old
  • If female, need to be using a contraceptive
  • Have no history of psychiatric disorder or serious medical illness
Reilly, James LReilly, James L
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT04258826 STU00211277
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FLUVOXAMINE FOR EARLY TREATMENT OF COVID-19: A FULLY-REMOTE, RANDOMIZED PLACEBO CONTROLLED TRIAL

STOP COVID Trial is a randomized controlled trial that aims to help slow the progression of COVID-19 symptoms in symptomatic patients in the United States. The study is contactless meaning vol…

STOP COVID Trial is a randomized controlled trial that aims to help slow the progression of COVID-19 symptoms in symptomatic patients in the United States. The study is contactless meaning volunteers may participate without leaving their home. Medication and study supplies are delivered by a courier or shipped overnight. We hope our study will demonstrate whether or not taking a medication, fluvoxamine, will help to prevent worsening of symptoms and prevent hospitalization.

You may be eligible if you:

  • Are age 30 or older
  • Tested positive for COVID-19
  • Are experiencing symptoms of COVID-19
  • Have current symptoms of COVID-19 that started within the past 6 days.
  • Have at least one of the following risk factors for developing serious COVID-19: age 40 or older, African-American, Hispanic/Latino, Native American, obesity, hypertension, or immune disease
  • Have not been vaccinated against COVID-19

You may be ineligible if you:

  • Are experiencing severe symptoms that require hospitalization
  • Are unable to take the study medication, fluvoxamine
  • Are taking one or more of the following medications: sertraline, donepezil, coumadin (warfarin), plavix (clopidogrel)

Rado, Jeffrey ThomasRado, Jeffrey Thomas
  • Map it 680 N. Lake Shore Dr.
    Chicago, IL
NCT04668950 STU00213714
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