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Tapering Off Antidepressants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02661828
Recruitment Status : Terminated (Inadequate recruitment)
First Posted : January 25, 2016
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Boadie W. Dunlop, Emory University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Anxiety Disorder Obsessive Compulsive Disorder Post-Traumatic Stress Disorder Other: Two-Week Antidepressant Taper Regimen Other: One-Week Antidepressant Taper Regimen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Two Antidepressant Tapering Regimens
Study Start Date : January 2016
Actual Primary Completion Date : March 17, 2017
Actual Study Completion Date : March 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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.




Primary Outcome Measures :
  1. Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores [ Time Frame: Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline) ]

    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:

    1. New symptom
    2. Old symptom but worse
    3. Old symptom but improved
    4. Old symptom but unchanged
    5. 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 :
  1. Physician Withdrawal Checklist (PWC-20) Scores [ Time Frame: Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline) ]

    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

    1. Mild
    2. Moderate
    3. Severe

    Total scores range from 0 to 60 with higher scores indicating more severe symptoms.


  2. Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome [ Time Frame: Duration of Study (Up to 14 Months) ]

    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:

    1. New symptom
    2. Old symptom but worse
    3. Old symptom but improved
    4. Old symptom but unchanged
    5. Symptom not present



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:

  • 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.

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): NCT02661828


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
The Emory Clinic
Atlanta, Georgia, United States, 30322
12 Executive Park Drive, 3rd floor
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Boadie Dunlop, MD Emory University
  Study Documents (Full-Text)

Documents provided by Boadie W. Dunlop, Emory University:
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Responsible Party: Boadie W. Dunlop, Boadie W. Dunlop, MD, Emory University
ClinicalTrials.gov Identifier: NCT02661828    
Other Study ID Numbers: IRB00084849
First Posted: January 25, 2016    Key Record Dates
Results First Posted: September 25, 2018
Last Update Posted: September 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Boadie W. Dunlop, Emory University:
Tapering Antidepressant Regimen
Antidepressant Discontinuation Syndrome
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depressive Disorder, Major
Stress Disorders, Traumatic
Anxiety Disorders
Stress Disorders, Post-Traumatic
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Trauma and Stressor Related Disorders
Personality Disorders
Antidepressive Agents
Psychotropic Drugs