Treatments for Anxiety: Meditation and Escitalopram

NCT03522844 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2017-1464
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 3

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.

Conditions

Anxiety Disorders; Generalized Anxiety Disorder; Panic Disorder; Social Anxiety Disorder; Agoraphobia

Keywords

mindfulness; escitalopram; anxiety

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression of Severity scale

  The CGI is a measure of symptom severity and is rated by a clinician

  8 weeks

Secondary Outcomes (11)

• Clinical Global Impression- Improvement (CGI-I)

  8 weeks

• Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A)

  8 weeks

• Liebowitz Social Anxiety Scale (LSAS)

  8 weeks

• Panic Disorder Severity Scale (PDSS)

  8 weeks

• Overall Anxiety Severity and Impairment Scale (OASIS)

  8 weeks

Study Arms (2)

Mindfulness-Based Stress Reduction (MBSR)

EXPERIMENTAL

Other: Mindfulness-Based Stress Reduction

Escitalopram

ACTIVE COMPARATOR

Drug: Escitalopram

Interventions

Mindfulness-Based Stress Reduction OTHER

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.

Mindfulness-Based Stress Reduction (MBSR)

Escitalopram DRUG

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 10 mg/day; 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.

Escitalopram

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• A serious medical condition that may result in surgery or hospitalization.
• A history of head trauma causing loss of consciousness, or ongoing cognitive impairment
• Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview).
• Subjects who will be non-compliant with the study procedures. This may include planned travel out of town.
• 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.
• 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).
• Individuals who have completed a course of MBSR or an equivalent meditation training in the last year, or have an ongoing daily meditation practice
• Individuals reporting significant active suicidal ideation or suicidal behaviors within the past year.
• 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.

Sponsors & Collaborators

• Georgetown University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

New York University

New York, New York, 10016, United States

Location

Related Publications (4)

• Hoge EA, Mete M, Baker AW, Szuhany KL, Armstrong CH, Steinberg MH, Dutton MA, Bui E, Simon NM. A randomized controlled trial comparing mindfulness to escitalopram for anxiety: In-person and remote, synchronous delivery pre and post COVID-19 pandemic. J Affect Disord. 2025 Sep 1;384:163-172. doi: 10.1016/j.jad.2025.04.145. Epub 2025 May 3.

  PMID: 40324655 DERIVED

• Hu H, Mete M, Rustgi NK, Washington CI, Sanghavi K, Dutton MA, Simon NM, Baker AW, Bui E, Hoge EA. Mindfulness Meditation vs Escitalopram for Treatment of Anxiety Disorders: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2438453. doi: 10.1001/jamanetworkopen.2024.38453.

  PMID: 39382900 DERIVED

• Oft AC, Philip S, Holz E, Sathi S, Geng X, Hoge E. Effect of meditation or escitalopram on work performance in patients with anxiety disorders. J Affect Disord. 2024 Nov 1;364:104-107. doi: 10.1016/j.jad.2024.08.019. Epub 2024 Aug 10.

  PMID: 39134156 DERIVED

• Hoge EA, Bui E, Mete M, Dutton MA, Baker AW, Simon NM. Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Jan 1;80(1):13-21. doi: 10.1001/jamapsychiatry.2022.3679.

  PMID: 36350591 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder; Panic Disorder; Phobia, Social; Agoraphobia

Interventions

Mindfulness-Based Stress Reduction; Escitalopram

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 11, 2018
• Study Start: June 18, 2018
• Primary Completion: October 31, 2021
• Study Completion: January 5, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)