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Trial record 100 of 585 for:    ESCITALOPRAM

Treatments for Anxiety: Meditation and Escitalopram (TAME)

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ClinicalTrials.gov Identifier: NCT03522844
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : April 15, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Elizabeth Hoge, Georgetown University

Brief Summary:
We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) with a medication for anxiety disorders. We will use escitalopram, gold-standard SSRI treatment for patients with anxiety disorders, and will examine the comparative effectiveness of the two treatments on anxiety symptoms and other outcomes important to patients.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Generalized Anxiety Disorder Panic Disorder Social Anxiety Disorder Agoraphobia Other: Mindfulness-Based Stress Reduction Drug: Escitalopram Phase 4

Detailed Description:

Mindfulness meditation treatments have been growing in popularity and becoming widely disseminated, and people with anxiety are interested in mindfulness. A benefit of mindfulness interventions is that they can be provided outside of a mental health setting, which may make them more acceptable to patients. Although mindfulness meditation is gaining popularity, there is no information how this treatment strategy compares with standard treatment, such as with medication. Patients need more information about the comparison of treatments to be able to make informed decisions about their health care. We propose the first randomized, controlled study to assess the comparative effectiveness of Mindfulness-Based Stress Reduction (MBSR) compared to escitalopram, a standard medication for patients with anxiety disorders such as generalized anxiety disorder, social anxiety disorder, panic disorder, and agoraphobia.

Patients will be randomized into two 8-week treatments: (1) MBSR and (2) escitalopram. To enroll the necessary sample, we will utilize three study sites in different geographic locations that each have strong clinical and research infrastructures: Georgetown University Medical Center, Massachusetts General Hospital and New York University Langone Medical Center. Thus, we will take advantage of three productive teams with previous successful collaborations and experience in mind-body treatment studies.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to receive one of two treatments over the course of 8-weeks. One group will participate in an 8-week Mindfulness-Based Stress Reduction Course and the other group will receive a daily medication treatment (escitalopram).
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : May 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Mindfulness-Based Stress Reduction (MBSR) Other: Mindfulness-Based Stress Reduction
Participants randomized to the MBSR intervention will consist of an 8-week Mindfulness-Based Stress Reduction (MBSR) program, taught and facilitated by a trained instructor. The classes instruct participants in the theory and practice of several forms of mindfulness meditation: a body scan, breathing awareness, and mindfulness stretching exercises designed to bring awareness of the body and current experience of movement. The intervention will include a weekly class for 8 weeks and classes will be 2.5 hours in duration. The intervention will also include a 1-day (7 hours) retreat on a weekend at the end of the program. Participants will also be asked to engage in 45 minutes of practice at home on a daily basis, as well as informal practice assignments that instruct participants to bring mindfulness to current daily activities.

Active Comparator: Escitalopram Drug: Escitalopram
Escitalopram is an antidepressant, widely used to treat anxiety disorders. During the 8 weeks of randomized treatment with escitalopram, subjects will be seen regularly by a study physician. The pill medication will be initiated at 5 mg/day; which will be continued to week 1, when it will be increased to 10 mg/day if well tolerated (or delayed if not). At week 2, dosage will be increased to 20 mg/day if well tolerated (or delayed if not). Side effects will be assessed at each visit and recorded.




Primary Outcome Measures :
  1. Clinical Global Impression of Severity scale [ Time Frame: 8 weeks ]
    The CGI is a measure of symptom severity and is rated by a clinician


Secondary Outcome Measures :
  1. Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: 8 weeks ]
    The OASIS is a measure is anxiety symptoms

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks ]
    The PSQI is a measure of sleep

  3. Penn State Worry Questionnaire (PSWQ) [ Time Frame: 8 weeks ]
    The PSWQ is a patient-reported measure of worry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women between 18 and 75 years old.
  2. Have an anxiety disorder, including: social anxiety disorder (SAD), generalized anxiety disorder (GAD), panic disorder, or agoraphobia
  3. Must understand study procedure and willing to participate in all testing visits, and treatment as assigned.
  4. Participants must be able to give informed consent to the study procedures.

Exclusion Criteria:

  1. Comorbid psychiatric disorder other than anxiety or depression, such as psychotic disorder, post-traumatic stress disorder, obsessive compulsive disorder, eating disorders, bipolar disorder; developmental or organic mental disorders; and current (past 6 months) substance use disorders.
  2. A serious medical condition that may result in surgery or hospitalization.
  3. A history of head trauma causing loss of consciousness, or ongoing cognitive impairment
  4. Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview).
  5. Subjects who will be non-compliant with the study procedures. This may include planned travel out of town.
  6. Pregnancy as assessed by urine test at screen. Avoidance of pregnancy is also necessary for inclusion in the study.
  7. Subjects taking barbiturates, SSRIs, anti-depressants, or antipsychotics. Sleep medications (other than anti-depressants) and benzodiazepines will be allowed, if has been taken at stable dose 4 weeks prior to baseline and the patient plans to continue at the same dose through the trial. Trazadone (for sleep) above 100mg will be disallowed.
  8. Concurrent psychotherapy initiated within 1 month of screen interview, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety (such as cognitive behavioral therapy).
  9. Individuals who have completed a course of MBSR or an equivalent meditation training in the last year, or have an ongoing daily meditation practice
  10. Individuals reporting significant active suicidal ideation or suicidal behaviors within the past year.
  11. Individuals with a medical condition (i.e., epilepsy) that may be exacerbated by study treatment, as determined by a study physician or nurse practitioner based on history, physical, and/or labs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522844


Contacts
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Contact: Elizabeth A Hoge, MD 202-687-0635 eah103@georgetown.edu
Contact: Samantha R Philip, BS 202-687-7283 sp1256@georgetown.edu

Locations
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United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Elizabeth A Hoge, MD    202-687-0635    eah103@georgetown.edu   
Contact: Samantha R Philip, BS    202-687-7283    sp1256@georgetown.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Eric Bui, Md, PhD    617-726-3508      
Contact: Meredith Ward, BA    617-726-1579    MJWARD@mgh.harvard.edu   
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: Naomi Simon, MD    646-754-7035      
Contact: Rebecca Suzuki    646-754-4773    Rebecca.Suzuki@nyumc.org   
Sponsors and Collaborators
Georgetown University
Patient-Centered Outcomes Research Institute

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Responsible Party: Elizabeth Hoge, Principal Investigator, Georgetown University
ClinicalTrials.gov Identifier: NCT03522844     History of Changes
Other Study ID Numbers: 2017-1464
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Elizabeth Hoge, Georgetown University:
mindfulness
escitalopram
anxiety

Additional relevant MeSH terms:
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Citalopram
Dexetimide
Disease
Anxiety Disorders
Panic Disorder
Phobia, Social
Agoraphobia
Pathologic Processes
Mental Disorders
Phobic Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents