Tapering Off Antidepressants

NCT02661828 | Terminated Results

• 1 other identifier: IRB00084849
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

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.

Conditions

Major Depressive Disorder; Anxiety Disorder; Obsessive Compulsive Disorder; Post-Traumatic Stress Disorder

Keywords

Tapering Antidepressant Regimen; Antidepressant Discontinuation Syndrome

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)

Secondary Outcomes (2)

• Physician Withdrawal Checklist (PWC-20) Scores

  Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)

• Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome

  Duration of Study (Up to 14 Months)

Study Arms (2)

Taper A Regimen

ACTIVE COMPARATOR

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

Taper B Regimen

ACTIVE COMPARATOR

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

Interventions

Two-Week Antidepressant Taper Regimen OTHER

Days 1-7: 50% of baseline antidepressant dose taken; Days 8-14: 25% of baseline antidepressant dose taken; Day 15: Stop antidepressant.

Taper A Regimen

One-Week Antidepressant Taper Regimen OTHER

Days 1-3: 50% of baseline antidepressant dose taken; Days 4-7: 25% of baseline antidepressant dose taken; Day 8: Stop antidepressant.

Taper B Regimen

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

12 Executive Park Drive, 3rd floor

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders; Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Boadie Dunlop, MD
• Organization: Emory University

vcruz@emory.edu

404-727-8474

Study Officials

• Boadie Dunlop, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Boadie W. Dunlop, MD

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 25, 2016
• Study Start: January 1, 2016
• Primary Completion: March 17, 2017
• Study Completion: March 17, 2017
• Last Updated: September 25, 2018
• Results First Posted: September 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)