search
Back to results

Tapering Off Antidepressants

Primary Purpose

Major Depressive Disorder, Anxiety Disorder, Obsessive Compulsive Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Two-Week Antidepressant Taper Regimen
One-Week Antidepressant Taper Regimen
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Tapering Antidepressant Regimen, Antidepressant Discontinuation Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University
  • The Emory Clinic
  • 12 Executive Park Drive, 3rd floor

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Taper A Regimen

Taper B Regimen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
January 20, 2016
Last Updated
September 21, 2018
Sponsor
Emory University
search

1. Study Identification

Unique Protocol Identification Number
NCT02661828
Brief Title
Tapering Off Antidepressants
Official Title
A Comparison of Two Antidepressant Tapering Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 17, 2017 (Actual)
Study Completion Date
March 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Anxiety Disorder, Obsessive Compulsive Disorder, Post-Traumatic Stress Disorder
Keywords
Tapering Antidepressant Regimen, Antidepressant Discontinuation Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taper A Regimen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Taper B Regimen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Two-Week Antidepressant Taper Regimen
Intervention Description
Days 1-7: 50% of baseline antidepressant dose taken; Days 8-14: 25% of baseline antidepressant dose taken; Day 15: Stop antidepressant.
Intervention Type
Other
Intervention Name(s)
One-Week Antidepressant Taper Regimen
Intervention Description
Days 1-3: 50% of baseline antidepressant dose taken; Days 4-7: 25% of baseline antidepressant dose taken; Day 8: Stop antidepressant.
Primary Outcome Measure Information:
Title
Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores
Description
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.
Time Frame
Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)
Secondary Outcome Measure Information:
Title
Physician Withdrawal Checklist (PWC-20) Scores
Description
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.
Time Frame
Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)
Title
Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome
Description
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
Time Frame
Duration of Study (Up to 14 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boadie Dunlop, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
12 Executive Park Drive, 3rd floor
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tapering Off Antidepressants

We'll reach out to this number within 24 hrs