Clinical trial NCT02661828: Tapering Off Antidepressants
Official title: A Comparison of Two Antidepressant Tapering Regimens
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Major Depressive Disorder
Anxiety Disorder
Obsessive Compulsive Disorder
Post-Traumatic Stress Disorder
Keywords: Tapering Antidepressant Regimen
Antidepressant Discontinuation Syndrome
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores
timeFrame: Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)
Secondary outcomes:
measure: Physician Withdrawal Checklist (PWC-20) Scores
timeFrame: Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)
measure: Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome
timeFrame: Duration of Study (Up to 14 Months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: 12 Executive Park Drive, 3rd floor
state: Georgia
Study officials:
affiliation: Emory University
name: Boadie Dunlop, MD
role: PRINCIPAL_INVESTIGATOR
References: