Tapering Off Antidepressants

Major Depressive Disorder Clinical Trial

Official title:

A Comparison of Two Antidepressant Tapering Regimens

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02661828
• Other study ID #: IRB00084849
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 17, 2017

Study information

• Verified date: January 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 17, 2017
• Est. primary completion date: March 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	12 Executive Park Drive, 3rd floor	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)