Bipolar Disorder Clinical Trials - Mayo Clinic Research (2023)

  • A Biobank for Bipolar Disorder, by Mayo Clinic Individualized Medicine Scottsdale/Phoenix, AZ; Austin, MN; Rochester, MN; Jacksonville, FL; Eau Claire, WI

    The purpose of this biobank is to develop a research resource for bipolar disorder. Patients, and close genetic relatives, will provide samples of blood, complete interviews, completehealth questionnaires, and allow access to medical records. Participants will also agree to be followed into the future by linking to medical records, along with occasional follow-up health surveys or collection of additional biologic specimens. The biobank serves as a source for researchers instead of having to look for volunteers for each new project.

  • Bipolar Disorder Measures in Clinical Care Rochester, MN

    The purpose of this study is to obtain input from people with bipolar disorder to choose the preferred measure for monitoring bipolar disorder symptoms that is understandable, acceptable, and helpful in informing when to change treatment.

  • A Study of Interpersonal and Social Rhythm Therapy for Outpatients with Bipolar Disorder Rochester, MN

    The purpose of this study is todetermine if interpersonal and social rhythm therapy for patients who have bipolar disorder can be delivered in the formal program group psychotherapy format of the outpatient mood program.

  • A Study of the Effects of Lamotrigine or Fluoxetine on the Brain in Bipolar Depression Using an MRI Scan Before and After Treatment Rochester, MN

    This study uses an MRI scan called an MR Spectroscopy to measure brain chemicals before and after treatment with lamotrigine or fluoxetine in patients with bipolar depression. This better understanding of therapy impact on brain function may help individualize future treatment for bipolar depression.

  • Medibio Depression Monitoring Study Rochester, MN

    The purpose of this study is toexplore whether Medibio’s system can provide objective measures of response to standard medication treatment for unipolar depression and bipolar depression, and to see if the system can tell these two conditions apart.

    Medibio’s system uses software to analyse a person’s heart rate, activity, and posture to provide objective measures of a person’s autonomic nervous system, sleep, and other daily patterns.

  • The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression. Rochester, MN

    The purpose of this research study is to find out if the medication known as ketamine can help the symptoms of depression. This drug is approved by the Food and Drug Administration (FDA) but the investigators will use it for a non-FDA approved reason (depression).

  • An Open Label Trial of TMS Therapy for Bipolar Depression Rochester, MN

    Transcranial Magnetic Stimulation (TMS) is an increasingly accepted neurostimulation- based treatment for major depressive disorder. While there is a growing anecdotal database supporting its use in bipolar depression the investigators propose to collect open label efficacy and safety data in a small population of patients with clinically verified bipolar disorder.

  • 8 Week Multi-site Study of MYDAYIS® for Bipolar Depression Rochester, MN; Austin, MN; Austin, MN; Eau Claire, WI

    The purpose of this study is to assess the effectiveness and safety of MYDAYIS® as an augmentation agent for bipolar depression.

  • A Study to Determine Whether Ongoing Assessment Aids Treatment No Locations

    The purposes of this study areto summarize clinician evaluations of the NNDC battery in thesingle clinic where the adult battery is currently being administered to adolescents, to determine patient and clinician level of interest in using the NNDC battery in clinics where the adult battery is not currently being administered to adolescent patients (n=14), to measure change in evaluation 3 months post-implementation for any sites that begin administering the NNDC battery to adolescents, and to generate potential new Child and Adolescent Mood Disorders Interest Group (CAMDIG) research protocols for future consideration.

  • Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine Rochester, MN

    Quetiapine, a second generation antipsychotic, is only available as oral tablets. However, topical and rectal formulations have been produced in compounding pharmacies. There is no data available suggesting that topical or rectal formulations provide serum levels similar to oral medication. In the clinical setting, when oral administration of quetiapine is not possible (for example, when a patient is extremely ill physically or mentally or both), clinicians and pharmacists have collaborated in such cases and have at times had to administer quetiapine compounded in other dosage formulations such as rectal or topical formulations. Despite clinical effectiveness of these "other" formulations, there ...

  • A Study of State-Specific Blood Marker Investigation in Bipolar and Schizoaffective Disorder Rochester, MN

    The purpose of this study is to find out if some patients with mood symptoms have antibodies (part of the immune system) that affect the brain, and could possibly play a role in the development of mood symptoms. We also want to find out if these immune markers change once your mood normalizes.

  • 16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression Rochester, MN; Austin, MN

    The FLAME Study is a 16-week clinical trial to study treatment with lamotrigine or fluoxetine in bipolar I, II and bipolar schizoaffective depressed adults. The purpose of the trial is to have a better understanding of whether individuals with a particular gene type and other inherited biological markers will have a good response to fluoxetine or lamotrigine, or alternatively, would be more likely to have side effects to this medication.

  • Bipolar Depression Before and After Lamotrigine Treatment With Lamictal® Rochester, MN

    This study will compare glutamate and other neurometabolites measured by proton magnetic resonance spectroscopy (1H-MRS) in bipolar I and II patients currently depressed with age-matched healthy controls. The study will also compare 1H-MRS of bipolar I and II patients before and after taking a 12-week course of lamotrigine. This study requires 8 visits over a 12 week period. These visits need to occur at Mayo Clinic in Rochester, MN.

  • Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine Rochester, MN

    The purpose of this research study is to compare the antidepressant effect of lithium versus placebo in adults receiving ketamine. Lithium is available commercially for depression; ketamine is available commercially and can help the symptoms of depression; however, it has not been approved by the U.S. Food and Drug Administration (FDA) for this use. The FDA has allowed the use of this drug in this research study.

  • Study to Distinguish Mood Disorders Rochester, MN

    The goal of this proposed study is to examine the genetic signature of the validated proteomic signature (model) based on a panel of serum proteomic markers that discriminates different mood disorders.

  • Rochester, MN

    In an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to 1) evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity); 2) evaluate the effectiveness of evidence-based intervention components on emotional and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.

  • Systemic Inflammation Related to Mood Disorders Rochester, MN

    The overall goal is to better understand the underlying pathophysiology of mood disorders and bipolar disorders in particular.We aim to investigate whether the subclinical atherosclerotic and inflammatory markers differ between patients with bipolar disorder, major depressive disorder, and psychiatric non-mood disorders and healthy subjects.

  • A Study to Evaluate Positive SARS-CoV-2 Antibodies in Subjects with Bipolar Disorder Rochester, MN

    The purpose of this study is to evaluate the clinical and neurocognitive correlates of COVID-19 in patients with bipolar disorder (BD).

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