Anxiety Disorder, Major Depressive Disorder, Obsessive Compulsive Disorder, Post-Traumatic Stress Disorder
Conditions
Keywords
Tapering Antidepressant Regimen, Antidepressant Discontinuation Syndrome
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.
Interventions
OTHERTwo-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.
OTHEROne-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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Physician Withdrawal Checklist (PWC-20) Scores | 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. |
| Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome | 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 |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from January 2016 through March 2017.
Pre-assignment details
Of the two participants who signed consent, one subject began study participation for which data were collected.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 1 |
| 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.
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. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Taper A Regimen | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Age, Continuous | 47 years | 47 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
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: 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.
Time frame: Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Taper A Regimen | Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores | Baseline (Post-Taper) | 0 units on a scale |
| Taper A Regimen | Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores | Visit 4 | 6 units on a scale |
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: 1. New symptom 2. Old symptom but worse 3. Old symptom but improved 4. Old symptom but unchanged 5. Symptom not present
Time frame: Duration of Study (Up to 14 Months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Taper A Regimen | Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome | 1 Participants |
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 1. Mild 2. Moderate 3. Severe Total scores range from 0 to 60 with higher scores indicating more severe symptoms.
Time frame: Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Taper A Regimen | Physician Withdrawal Checklist (PWC-20) Scores | Baseline (Post-Taper) | 15 units on a scale |
| Taper A Regimen | Physician Withdrawal Checklist (PWC-20) Scores | Visit 4 | 15 units on a scale |