Clinical Trials

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11 studies in Department of Psychiatry and Psychology in Rochester, MN.

  1. DNA Repository for Addictions

    Rochester, Minn. View Summary

    DNA Repository for Addictions

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This resource will be used to study variation in DNA possibly associated with developing addiction and response to treatment.

    IRB Number:

    2681-04

    Who can I contact for additional information about this study?

    Addictions Study Coordinator, 1-877-751-6444 (toll-free), psychaddiction@mayo.edu
  2. A Randomized-controlled Study Comparing Two Treatments for Children With Anxiety Disorders

    Rochester, Minn. View Summary

    A Randomized-controlled Study Comparing Two Treatments for Children With Anxiety Disorders

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Anxiety disorders are among the most common psychiatric disorders in children and typically produce significant disruption in family, social, and academic functioning (Merikangas & Avenevoli, 2002). Fortunately, treatments for childhood anxiety have been manualized and found to be efficacious (Walkup, et al., 2008). These treatments most often incorporate aspects of cognitive-restructuring, relaxation training, and exposure to anxiety-producing stimuli. Unfortunately, many practitioners opt to utilize mainly cognitive and relaxation techniques at the expense of exposure techniques (Freiheit, Vye, Swan, & Cady, 2004). However, it remains unclear which of these components is most effective in reducing anxiety symptoms or the extent to which they act in concert; thus, the relative effectiveness of treatment for childhood anxiety when leaving-out a treatment component is unknown. The current study aims to compare the relative effectiveness of exposure therapy for childhood anxiety to cognitive restructuring and relaxation techniques. Sixty children and adolescents seeking treatment for anxiety in an outpatient pediatric anxiety clinic will be randomized to receive either six sessions of parent assisted exposure therapy or six sessions of individual cognitive restructuring and relaxation training. Comprehensive assessments will be completed by trained clinicians at pre-treatment and again at post-treatment to measure reductions in anxiety and related symptoms as well as improvements in daily functioning. We anticipate that children treated with exposure therapy will demonstrate significantly greater improvement over the six sessions than children treated with cognitive-restructuring and relaxation training, and will require fewer additional treatment sessions. Support of this hypthothesis would clarify the active ingredients in manualized treatment for childhood anxiety disorders and would potentially lead to quicker, more efficient treatment.

    NCT ID:

    NCT01624584

    IRB Number:

    11-008970

    Who can I contact for additional information about this study?

    Rochester: Kay Nevinger 507-293-0089
                        


  3. Acute and Maintenance Intravenous Ketamine for Treatment Resistant Major Depression With Suicidal Ideation/Attempt

    Rochester, Minn. View Summary

    Acute and Maintenance Intravenous Ketamine for Treatment Resistant Major Depression With Suicidal Ideation/Attempt

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Study hypothesis: Do serial low-dose ketamine infusions, followed by weekly maintenance infusions, increase the length of time depressive symptoms stay in remission and the length of time associated suicide risk is improved? Brief Summary: This open label clinical trial is intended to further clarify initial response to low-dose ketamine infusion with repeated dosing and maintenance treatment model. Primary outcomes will be reduction in depression severity and reduction of suicide risk along with duration of response.

    NCT ID:

    NCT02094898

    IRB Number:

    13-005152

    Who can I contact for additional information about this study?

    Rochester: Timothy W Lineberry, MD
                        


  4. Longitudinal Study of Cognition With Niemann-Pick Disease, Type C

    Rochester, Minn. View Summary

    Longitudinal Study of Cognition With Niemann-Pick Disease, Type C

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Niemann-Pick Disease, Type C (NPC) is a rare neurodegenerative disorder with a wide clinical spectrum and variable age of onset. Classically, children with NPC demonstrate neurological dysfunction with cerebellar ataxia (an inability to coordinate balance, gait, extremity and eye movements), dysarthria (difficulty speaking), seizures, vertical gaze palsy (ability to move eyes in the same direction) motor impairment, dysphagia (trouble swallowing), psychotic episodes, and progressive dementia. There is no curative treatment for NPC and it is a lethal disorder. The purpose of this protocol is to obtain both baseline and rate of progression data on a clinical and biochemical markers that may later be used as outcome measures in a clinical trial. Specifically, this study will examine and characterize the longitudinal progression of neurocognitive symptoms of NPC with the goal of identifying early markers of disease progression that may be utilized in later trials to evaluate treatment efficacy.

    NCT ID:

    NCT01899950

    IRB Number:

    11-003868

    Who can I contact for additional information about this study?

  5. Pharmacologic Dissection of Vestibular Migraine and Chronic Subjective Dizziness: A Double-Blind Parallel Group Trial Comparing Response to Verapamil Versus Sertraline

    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    Pharmacologic Dissection of Vestibular Migraine and Chronic Subjective Dizziness: A Double-Blind Parallel Group Trial Comparing Response to Verapamil Versus Sertraline

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Chronic dizziness and recurrent vertigo are frequent complaints in primary and specialty medical care settings. Two common causes of these symptoms are vestibular migraine (VM) and chronic subjective dizziness (CSD), which may be seen in up to 25% of patients examined in tertiary neurotology centers. However, VM and CSD are relatively new diagnoses that have not yet been validated. Furthermore, recent research found that they co-exist 30% of the time with overlap in several features. From a clinical standpoint, this makes it difficult to diagnose and treat them well. From a research standpoint, it confounds subject selection for mechanistic investigations. The primary goal of this study to dissect VM and CSD in order to identify the key features and clarify the diagnostic criteria of each condition. Fifty patients diagnosed with coexisting VM-CSD will be treated with either verapamil or sertraline. Based on clinical and research experience to date, verapamil is thought to have greater effect on migraine-related symptoms, whereas sertraline is thought to have greater effect on CSD-related symptoms. It is hypothesized that a differential treatment response to these two pharmacologic probes will help to tease apart the unique clinical features of VM and CSD and identify risk factors that are shared or separate between the two conditions. The different mechanisms of action of the two study medications may also shed light on the physiologic underpinnings of VM and CSD. This project will be a 14-week, prospective, randomized, double-blind, parallel group, pharmacologic dissection trial. A 12-week treatment period will follow 2 weeks of baseline observation. Patients will chart daily headache and vestibular symptoms. VM and CSD symptoms and potential confounds such as anxiety and depression will be measured at two week intervals. Data will be analyzed for differential and shared treatment effects that align with or oppose current concepts of VM and CSD.

    NCT ID:

    NCT01669304

    IRB Number:

    12-002814

    Who can I contact for additional information about this study?

    Rochester: Jeffrey P Staab, MD 507-284-4159
                        Sherrie M Hanna 507-538-8341


  6. Magnetic Resonance Spectroscopy Probe Study of Alcohol Use

    Rochester, Minn. View Summary

    Magnetic Resonance Spectroscopy Probe Study of Alcohol Use

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    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

    NCT ID:

    NCT01679444

    IRB Number:

    12-003693

    Who can I contact for additional information about this study?

  7. Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline

    Rochester, Minn. View Summary

    Support Person Effectiveness Study to Promote Smoker Utilization of the QUITPLAN Helpline

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is being done to learn the helpfulness of a telephone-based program for support persons living in MN who are worried about a cigarette smoker living in MN.  This study will help support person learn new ways to be supportive as well as encourage a smoker to call the QUITPLAN Helpline.  The QUITPLAN Helpline is the tobacco Helpline for the state of Minnesota.  Research shows that Helpline?s are an effective way for smokers to quit or make a plan to quit.  The person you want to support does not need to be interested in or even thinking about quitting smoking in order for you to be in the study.   If the smoker does choose to call QUITPLAN, they are eligible for free services (counseling and/or nicotine replacement therapy) for seven months.  The seven months starts on the date of support person enrolling into our study.

    IRB Number:

    11-001796

    Who can I contact for additional information about this study?

    Christina Smith
    800.957.2950 toll-free
    507.538.8210 local
    supportpersonstudy@mayo.edu
  8. A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents

    Rochester, Minn. View Summary

    A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Part 2 of the study aims to: - Evaluate the benefit of daily, active, open-label rTMS in Part 1 non-responders. - Evaluate the benefits of bi-weekly, active, open-label maintenance rTMS treatment for Part 1 responders over the course of 12 months post acute treatment. - Evaluate, by proton magnetic resonance spectroscopy (1H-MRS) at 3 Tesla(3T), neurometabolic biomarkers at the beginning and end of each study phase. - Define regional specificity [anterior cingulate (AC) and left dorsolateral prefrontal cortex (L-DLPFC)] of cerebral metabolites (i.e. glutamate and glutamine) in adolescent depression. - Study whether specific neurochemical resonances are associated with response, remission, and/or maintenance of improvement of clinical depressive symptoms when rTMS is used to treat adolescent depression.

    NCT ID:

    NCT01804296

    IRB Number:

    12-003248

    Who can I contact for additional information about this study?

  9. 1H-MR Spectroscopy of Bipolar Depression Before and After Lamotrigine Treatment

    Rochester, Minn. View Summary

    1H-MR Spectroscopy of Bipolar Depression Before and After Lamotrigine Treatment

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Depression is the predominant prevailing pole in bipolar disorder and it is associated with substantial morbidity and mortality. However, in comparison to acute mania, bipolar depression is understudied both from the standpoint of its pathophysiology as well as clinical trials and FDA-approved treatments. With little guidance, clinicians and patients are limited as to what evidence-based treatment is available for bipolar depression. Proton magnetic resonance spectroscopy (1H-MRS) is a valuable, non-invasive method to study in-vivo brain biochemistry. Of the novel imaging paradigms, MRS is uniquely positioned to investigate biochemical mechanism of drug action that is objectively measurable and clinically relevant. As there is increasing interest in glutamatergic dysregulation in mood disorders, this project will utilize 1H-MRS at 3T to study glutamate and glutamine levels in brain regions implicated in bipolar disorder [anterior cingulate (Brodmann's areas 24a/b and 32) and dorsolateral prefrontal cortex (Brodmann's 9/46)]. The goal of this project is to evaluate whether anterior cingulate and prefrontal cortex glutamine, quantified as a CSF-corrected absolute concentration percent change from baseline, is associated with clinical remission (MADRS=12) to the anti-glutamatergic mood stabilizer lamotrigine. This is a 5-year single-site study (RO1 MH079261) of bipolar depression utilizing 1H-MR spectroscopy at 3T before and after treatment with lamotrigine.. At baseline bipolar depressed subjects and age-matched controls will undergo a 1H-MRS on a GE 3T Signa MRI scanner at Mayo Clinic Rochester. The bipolar depressed subjects will then be placed on 12-week, open evaluation of lamotrigine monotherapy. After 12 weeks, the bipolar subjects will undergo a second 1H-MRS scan.

    NCT ID:

    NCT01042496

    IRB Number:

    09-004163

    Who can I contact for additional information about this study?

    Rochester: Lee J Gunderson
                        


  10. Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination

    Rochester, Minn. View Summary

    Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent regurgitation of recently ingested food. Very little is understood about the nature and treatment of this disorder. The act of regurgitation in rumination involves the opening of the upper esophageal sphincter and the muscular contraction of the abdomins rectus. Behavioral treatment of these symptoms is the clinical intervention of choice; however, only uncontrolled case documentation exists to support its effectiveness. However, an effective behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint, muscular relaxation is incompatible with the necessary muscular contraction for rumination. To date, single case documentation and few designed single case studies have examined the clinical effectiveness of behavioral interventions for GI rumination. In the current study, the investigators seek to examine the effectiveness of two behavioral relaxation interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our primary goals are to examine the clinical effectiveness of these interventions in symptom reduction at 1- and 3-month follow-up.

    NCT ID:

    NCT01576302

    IRB Number:

    11-008528

    Who can I contact for additional information about this study?

    Rochester: Richard J Seime, Ph.D 507-284-2649
                        Jennifer M. Craft, Ph.D. 507 284 5849


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