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Clinical Studies
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16-week Open Randomized Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression: Pharmacogenomic and Biomarker Predictors of Response (FLAME)
Rochester, Minn.,
Austin, Minn.
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.
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1H-MR Spectroscopy Before and After Treatment with Lamotrigine or Fluoxetine in Bipolar Depression
Rochester, Minn.
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.
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1H-MR Spectroscopy of Bipolar Depression Before and After Lamotrigine Treatment (1HMRS-BP)
Rochester, Minn.
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.
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A 24-Week Open-Label Feasibility Trial of Varenicline for Alcoholic Cigarette Smokers
Rochester, Minn.
The purpose of this study is to see if varenicline will decrease alcohol consumption and increase alcohol abstinence rates when given to alcoholic patients for both alcohol and smoking cesation treatment.
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A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management of Depression (MOD)
Rochester, Minn.,
Austin, Minn.
The overall goal of this investigator-initiated trial is to evaluate the treatment outcome of depression utilizing platform algorithm products that can allow rapid identification of pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence.
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Chronobiology and Depression: Circadian Analytics as a Biomarker for Diagnosis and Longitudinal Monitoring of Depressive Subtypes
Rochester, Minn.
The purpose of this study is to explore 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.
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Clinical and Neurocognitive Correlates to Seropositivity for SARS-CoV-2 IgM/IgG Antibodies in Bipolar Disorder (COVID)
Rochester, Minn.
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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Comparison of Pharmacogenomic Testing Results Across Companies
Rochester, Minn.
The purpose of this study is to:
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To evaluate whether the genotypic and phenotypic results for a single subject are the same among companies offering pharmacogenomics testing.
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To evaluate the consistency among company generated lists of medications stratified into groups regarding usage for a single subject (i.e., “use as directed,” “use with caution,” or “use with increased caution and with more frequent monitoring”).
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Feasibility of Smartphone App MindLAMP in Developing Digital Phenotypes in Depression (LAMP)
Rochester, Minn.,
Austin, Minn.
The purpose of this study is to assess the feasibility and acceptability of passive data collection with a smartphone in depressed patients and investigate how passive data gathered via technology platforms can generate transdiagnostic digital phenotypes that potentially inform the assessment and/or treatment outcome of major mood disorders. This study aims to assess self-reported, behavioral, cognitive, and physiological data gathered from smartphones and smart watches as compared to gold standard clinical measured in treatment seeking depressed patients.
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Magnetic Resonance Spectroscopy Probe Study of Alcohol Use
Rochester, Minn.
This protocol will investigate the neurobiological underpinnings of alcohol craving in recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity.
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Mayo Clinic Individualized Medicine Biobank for Bipolar Disorder
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.,
Austin, Minn.,
Eau Claire, Wis.
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, complete health 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.
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Mayo Clinic Proteomic Informed Genomic/Epigenomic (PInG-PInE-1) Study to Distinguish Mood Disorders
Rochester, Minn.
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.
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Mood Stabilizer Pharmacogenomics Biobank (MoStGEN)
Austin, Minn.,
Scottsdale/Phoenix, Ariz.,
Mankato, Minn.,
Rochester, Minn.
The purpose of this study is to create a larger database and bio-repository to examine pharmacogenomics in patients with BD type I and type II treated with mood stabilizing anticonvulsants, atypical antipsychotics and antidepressant medications.
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Targeting mTOR/GSK3 With Lithium Augmentation to Enhance and Sustain Rapid Antidepressant Actions of Ketamine in Adults With Treatment-Resistant Depression: A Precision Medicine Approach for Psychiatry
Rochester, Minn.
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.
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