Tapering Off Antidepressants

A Comparison of Two Antidepressant Tapering Regimens

The purpose of this study is to compare two ways to stop taking an antidepressant medication and determine whether a faster or slower taper is better tolerated.

Study Overview

• Status: Terminated
• Conditions: Obsessive Compulsive Disorder; Major Depressive Disorder; Post-Traumatic Stress Disorder; Anxiety Disorder
• Intervention / Treatment: Other: Two-Week Antidepressant Taper Regimen; Other: One-Week Antidepressant Taper Regimen

Detailed Description

As abrupt cessation of antidepressant medication can cause distressing symptoms (including and not limited to worsened mood, irritability/agitation, anxiety, dizziness, confusion, and headache), the aim of this study is to compare the tolerance of two tapering regimens with the hypothesis that tapering the antidepressant dose over the course of two weeks will yield less discontinuation symptoms than a one week taper regimen. Additionally, it is suspected that discontinuing medications that inhibit the serotonin transporter , such as selective serotonin reuptake inhibitors (SSRI) and serotonin norepinephrine reuptake inhibitors (SNRI) will have a greater difference in the frequency of discontinuation symptoms between the two and one-week tapering regimens versus antidepressants that don't inhibit serotonin transporter.

Demographic and clinical features will also be identified that may predict discontinuation symptoms with the hypothesis that patients on SSRIs and SNRIs may experience more discontinuation symptoms versus patients on non-SSRI/SNRI medications. Whether or not the treatment duration is positively associated with the number of discontinuation symptoms will also be determined.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30329
      • 12 Executive Park Drive, 3rd floor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Currently taking an FDA-approved antidepressant for at least four weeks on the list of approved medications: SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone or vortioxetine), SNRIs (desvenlafaxine, duloxetine, levomilnacipran, venlafaxine) and other classes (amitriptyline, bupropion, desipramine, doxepin, mirtazapine, nefazodone, nortriptyline, phenelzine, selegiline, or tranylcypromine). Clomipramine, a tricyclic antidepressant approved for the treatment of OCD, will also be included, but will be classed as an SSRI for this study because inhibition of the serotonin transporter is its primary therapeutic mechanism.
• No longer wish to take the antidepressant medication they are currently prescribed, due to one of the following reasons: 1) ineffective for symptoms; 2) intolerable side effect; 3) improvement of their illness for sufficient duration that it is clinically appropriate to consider tapering the medication.
• Primary psychiatric diagnosis of major depressive disorder, an anxiety disorder, OCD, or PTSD.
• Ability to read and understand English language.

Exclusion Criteria:

• Has met criteria at any time during their life for a primary psychotic disorder (e.g. schizophrenia), or dementia.
• Meets criteria for DSM-5-defined substance use disorder within three months of the screening visit.
• Currently taking two or more antidepressants.
• Presents with a clinically significant suicide risk, as assessed by a study physician.
• Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
• Women who are currently pregnant or lactating, or plan to become pregnant during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Taper A Regimen; Participants taking an antidepressant for at least four weeks and no longer wish to take the antidepressant medication will undergo a Two-Week Taper Regimen to discontinue their medication.	Other: Two-Week Antidepressant Taper Regimen; Days 1-7: 50% of baseline antidepressant dose taken; Days 8-14: 25% of baseline antidepressant dose taken; Day 15: Stop antidepressant.
Active Comparator: Taper B Regimen; Participants taking an antidepressant for at least four weeks and no longer wish to take the antidepressant medication will undergo a One-Week Taper Regimen to discontinue their medication.	Other: One-Week Antidepressant Taper Regimen; Days 1-3: 50% of baseline antidepressant dose taken; Days 4-7: 25% of baseline antidepressant dose taken; Day 8: Stop antidepressant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores	To determine a change in the frequency of Discontinuation symptoms, the Discontinuation Emergent Signs and Symptoms Scale (DESS) will be administered by a trained clinician/rater to assess the frequency of discontinuation symptoms. The assessment has 43 items to evaluate discontinuation-emergent symptoms resulting from withdrawal from their antidepressant medication. Symptoms are rated on a scale of 1-5: New symptom; Old symptom but worse; Old symptom but improved; Old symptom but unchanged; Symptom not present Total score = sum of number of new symptoms and old (but worse) symptoms (score = 1) and old and unchanged symptom, absent, or old symptom but improved (score = 0); total possible range 0 to 43. Higher score = more symptoms.	Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Withdrawal Checklist (PWC-20) Scores	To determine a change in the Intensity of Discontinuation symptoms, the Physician Withdrawal Checklist (PWC-20) will be administered by a trained clinician/rater to assess the intensity of discontinuation symptoms. The assessment has 20 items evaluated to detect withdrawal symptoms. Symptoms are rated on a scale of 0-3. 0. Not present; Mild; Moderate; Severe Total scores range from 0 to 60 with higher scores indicating more severe symptoms.	Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)
Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome	Antidepressant Discontinuation Syndrome is defined as greater than or equal to 4 new or worsened Discontinuation Emergent Signs and Symptoms Scale (DESS) symptoms at a visit during the study. Symptoms are rated on a scale of 1-5: New symptom; Old symptom but worse; Old symptom but improved; Old symptom but unchanged; Symptom not present	Duration of Study (Up to 14 Months)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Boadie Dunlop, MD, Emory University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 17, 2017
• Study Completion (Actual): March 17, 2017

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Tapering Antidepressant Regimen; Antidepressant Discontinuation Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Trauma and Stressor Related Disorders; Depressive Disorder; Disease; Obsessive-Compulsive Disorder; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: IRB00084849

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO