Clinical Trials

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7 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. Cortical Excitability and Inhibition in Children and Adolescents With Major Depressive Disorder
    Rochester, Minn. View Summary

    Cortical Excitability and Inhibition in Children and Adolescents With Major Depressive Disorder

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study is focused on understanding the neurophysiology of major depressive disorder (MDD), and the impact of selective serotonin reuptake inhibitors (SSRIs) in children and adolescents. This is a cross-sectional study which will utilize single and paired-pulse transcranial magnetic stimulation (TMS) to collect measures of glutamatergic cortical excitability (the motor threshold and intracortical facilitation), and GABAergic cortical inhibition (the cortical silent period and intracortical inhibition) of the motor cortex in chilren and adolescents in various disease states of MDD. The optional proton magnetic resonance spectroscopy and imaging scans (MRS/MRI) at 3 Tesla (3T) will examine glutamate concentrations in the motor cortex and anterior cingulate cortex. This is a biomarker study (MRI/MRS and TMS neurophysiology measures); treatment is not provided in any form. This study will not utilize Repetitive Transcranial Magnetic Stimulation (rTMS).

    NCT ID:

    NCT01718730

    IRB Number:

    12-000335

    Who can I contact for additional information about this study?

    Rochester: Katrina Schaefer 507-255-5452
                        Paul Croarkin, D.O. 507-255-7164


  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?

    Rochester: Marc Patterson, MD 507-284-3351
                        


  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. 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
  7. Controlled Trial of Deep Brain Stimulation for Obsessive-Compulsive Disorder
    Rochester, Minn. View Summary

    Controlled Trial of Deep Brain Stimulation for Obsessive-Compulsive Disorder

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Obsessive-compulsive disorder (OCD) is a chronic and debilitating illness that affects between 2% and 3% of adults in the United States. People with OCD often experience persistent unwanted thoughts and carry out ritual-like behaviors to rid themselves of these obsessive thoughts. Additionally, OCD symptoms are usually tied with feelings of intense anxiety and functional impairment, making it important for people with OCD to seek effective treatment. Although there are currently many treatment options for OCD, including psychotherapy and medications such as serotonin reuptake inhibitors, between 40% and 60% of people with OCD only partially respond or do not respond at all to these treatment methods. Given the large percentage of people who do not respond to aggressive conventional treatments, alternative options are necessary for people with treatment-resistant OCD. Deep brain stimulation (DBS) is a procedure that involves the use of thin wires to carry electric current to parts of the brain associated with producing OCD symptoms. DBS has been effectively and safely used to treat movement disorders, such as Parkinson's disease, and may be beneficial in reducing OCD symptom severity. This study will evaluate the safety and effectiveness of DBS in treating people with severe and otherwise treatment-resistant OCD. Study participation through follow-up will last 4 years. Participants will be allowed to remain on any pre-surgical medications or behavioral therapy programs throughout the study. Before surgery, all participants will undergo a 3- to 4-day series of initial tests and examinations that will include a physical and neurological examination; blood and urine screening tests; an electrocardiogram (EKG); an electroencephalography (EEG); and detailed psychological testing, including tests of perception, learning, and memory. The EEGs may be performed again after surgery to measure potential changes in brain electrical activity due to DBS. On the day of the surgery, participants will take a low dose of anxiety medication, have a metal frame fixed to their heads for support during surgery, and undergo a magnetic resonance imaging (MRI) scan to determine where to place the stimulating wires. After being injected with a local anesthetic, participants will undergo the first part of the operation, which will involve the implantation of neurostimulators in the ventral caudate/ventral striatum brain region. For the second part of the operation, after participants are administered general anesthesia, they will have the implantable neurostimulators (INSs) placed in their chests and the connecting wires to the brain placed under their skin. The entire surgical procedure will take 3 to 4 hours, with a 1- to 2-day post-operative hospital stay for recovery. During the post-operative stay, participants will undergo x-rays and a computed tomography (CT) scan of the head. Two to 3 weeks after surgery, participants will be divided randomly into either a group that receives DBS immediately or a group that first receives sham DBS and then active DBS after 3 months. The level of stimulation will be adjusted individually and on the basis of each participant's response to the stimulation. Participants will complete rating forms, a clinical evaluation, and a check of the stimulators every month for the first 3 months, then at least every 3 months for the rest of the year, and then every 6 months for the remaining years of the study. On the Year 1 visit, participants will repeat the baseline detailed psychological testing. Periodically throughout the 4-year study, staff will contact participants by phone to ask about OCD symptoms, mood, anxiety, and possible side effects. Also throughout the study, participants will need to have the INSs replaced every 5 to 16 months on average. Participants will also be invited to participate in a related study that involves positron emission tomography (PET) scanning to determine how the stimulation changes activity in the brain. Participation in the separate PET study is optional and will not affect current study participation.

    NCT ID:

    NCT00640133

    Who can I contact for additional information about this study?

    Rochester: Cindy Stoppel 507-284-5914