A Comparison of Two Antidepressant Tapering Regimens
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Two-Week Antidepressant Taper Regimen (Other)
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.
干预措施: One-Week Antidepressant Taper Regimen (Other)
结局指标
主要结局
Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores
时间窗: 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.
次要结局
- Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome(Duration of Study (Up to 14 Months))
- Physician Withdrawal Checklist (PWC-20) Scores(Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline))
研究者
Boadie W. Dunlop
Boadie W. Dunlop, MD
Emory University