Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

Tapering Antidepressant RegimenAntidepressant 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)

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 RegimenOther

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 RegimenOther

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

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Emory University
Otherlead

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

The Emory Clinic

Atlanta, Georgia, 30322, United States

12 Executive Park Drive, 3rd floor

Atlanta, Georgia, 30329, United States

MeSH Terms

Conditions

Depressive Disorder, MajorAnxiety DisordersObsessive-Compulsive DisorderStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Results Point of Contact

Title: Boadie Dunlop, MD
Organization: Emory University

Study Officials

Boadie Dunlop, MD
Emory University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

2 participants (actual enrollment reported by the registry).

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 2016

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Tapering Off Antidepressants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Taper A Regimen

Taper B Regimen

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Taper A Regimen

Taper B Regimen

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations