Clinical Trials

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9 studies in Department of Psychiatry and Psychology

  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: Mark A Frye, MD
                        


  4. 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


  5. 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?

  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. 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?

  8. 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


  9. 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

    IRB Number:

    12-002730

    Who can I contact for additional information about this study?