Treatments for Anxiety: Meditation and Escitalopram

• Status: Active, not recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Citalopram; Dexetimide

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 be 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.