Tapering Off Antidepressants
关键词
抽象
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.
日期
| 最后验证: | 12/31/2017 |
| 首次提交: | 01/19/2016 |
| 提交的预估入学人数: | 01/19/2016 |
| 首次发布: | 01/24/2016 |
| 上次提交的更新: | 09/20/2018 |
| 最近更新发布: | 09/24/2018 |
| 首次提交结果的日期: | 03/19/2017 |
| 首次提交质量检查结果的日期: | 09/20/2018 |
| 首次发布结果的日期: | 09/24/2018 |
| 实际学习开始日期: | 12/31/2015 |
| 预计主要完成日期: | 03/16/2017 |
| 预计完成日期: | 03/16/2017 |
状况或疾病
干预/治疗
Other: Taper A Regimen
Other: Taper B Regimen
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: 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. | Other: Taper A Regimen Days 1-7: 50% of baseline antidepressant dose taken; Days 8-14: 25% of baseline antidepressant dose taken; Day 15: Stop antidepressant. |
| Active Comparator: 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. | Other: Taper B Regimen Days 1-3: 50% of baseline antidepressant dose taken; Days 4-7: 25% of baseline antidepressant dose taken; Day 8: Stop antidepressant. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores [Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)]
次要成果指标
1. Physician Withdrawal Checklist (PWC-20) Scores [Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)]
2. Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome [Duration of Study (Up to 14 Months)]
