Prolonging Remission in Depressed Elderly (PRIDE) (PRIDE)
研究概览
详细说明
While advances have been made in the acute treatment of geriatric depression, failure to maintain remission following successful treatment remains a major public health problem. In particular, loss of antidepressant response can result in ongoing functional impairment and increased risk of suicide. This is especially salient for severe and/or treatment resistant illness, even after successful ECT.
This trial builds upon the work of the Consortium for Research in Electroconvulsive Therapy (CORE) group that showed that continuation ECT and combination pharmacotherapy were equally effective in preventing relapse following response to acute ECT. We are now testing whether combined pharmacotherapy and ECT, individualized according to patient response, will be more effective in maintaining remission in depressed older adults than pharmacotherapy alone. Moving beyond the traditional fixed schedule for continuation ECT, we are introducing a novel Symptom-Titrated Algorithm-Based Longitudinal ECT (STABLE) regimen. The STABLE algorithm ensures that the timing of ECT treatments is based upon clinical need, helping to achieve the dual goals of adequately treating people showing early signs of symptom re-emergence, while preventing the over-treatment of patients who may be in a stable remission. The continuation therapy "usual care" comparator arm is the combination pharmacotherapy of Li plus VLF (PHARM).
At 7 sites, 322 patients will receive an acute course of right unilateral (RUL) ECT augmented by standardized medication (Phase I); 188 remitters are randomly assigned to one of the 2 groups and followed for 6 months (Phase II). To balance the amount of clinical contact, the schedule of clinic and telephone ratings will be identical for patients in both the PHARM and STABLE arms. For both groups, relapse is defined as Hamilton Rating Scale for Depression-24 (HRSD24) scores >21 at two consecutive time points, suicidality, or psychiatric hospitalization.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Georgia
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Augusta、Georgia、美国、30912
- Georgia Regents University
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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New Jersey
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Hoboken、New Jersey、美国、07030
- Hoboken University Medical Center (MSSM satellite site)
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New York
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Glen Oaks、New York、美国、11004
- The Zucker Hillside Hospital North Shore-LIJ Health System
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai
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New York、New York、美国、10032
- Columbia University/New York State Psychiatric Institute
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White Plains、New York、美国、10605
- Weill Cornell Medical College
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University Medical Center
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Texas
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Dallas、Texas、美国、75390
- University of Texas Southwestern Medical Center at Dallas
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- DSM-IV diagnosis of major depressive episode, unipolar, based on the Mini-International Neuropsychiatric Interview (M.I.N.I) for DSM-IV
- ECT is clinically indicated
Exclusion Criteria:
- Lifetime history of bipolar affective disorder, schizophrenia, schizoaffective disorder, or mental retardation
- Current diagnosis of delirium, dementia, or substance abuse/dependence in past 6 months as defined by DSM-IV-TR criteria
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：PHARM
lithium and venlafaxine
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Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
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实验性的：STABLE
ECT + VLF + Li
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Procedure: ECT RUL ultra brief pulse ECT, 4 treatments in one month and then treatment on an as-needed basis for 5 months Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at every week
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at every week
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 2
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 2
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 4
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 4
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 5
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 5
|
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 6
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 6
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 7
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 7
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 8
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 8
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 9
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 9
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 10
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 10
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 11
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 11
|
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 12
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 12
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 13
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 13
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 14
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 14
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 15
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 15
|
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 16
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 16
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 17
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 17
|
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 18
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 18
|
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 19
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 19
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 20
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 20
|
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 21
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 21
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 22
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 22
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured by a telephone interview at week 23
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured by a telephone interview at week 23
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
大体时间：Measured at clinic visits at week 24
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Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) Measured at clinic visits at baseline and weeks 2, 4, 6, 8, 10,12,14,16, 18, 20, 22, 24. Measured by a telephone interview at weeks 5, 7, 9, 11, 13, 15, 17, 19, 21, 23 |
Measured at clinic visits at week 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Level of functioning (SF-36)
大体时间：Measured at baseline
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Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at baseline
|
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Level of functioning (SF-36)
大体时间：Measured at week 4
|
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 4
|
|
Level of functioning (SF-36)
大体时间：Measured at week 8
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Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 8
|
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Level of functioning (SF-36)
大体时间：Measured at week 12
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Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 12
|
|
Level of functioning (SF-36)
大体时间：Measured at week 16
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Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 16
|
|
Level of functioning (SF-36)
大体时间：Measured at week 20
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Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 20
|
|
Level of functioning (SF-36)
大体时间：Measured at week 24
|
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 24
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at baseline
|
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at baseline
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 2
|
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 2
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 4
|
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 4
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 8
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Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 8
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 10
|
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 10
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 12
|
Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 12
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 14
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Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 14
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 16
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Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 16
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 18
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Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 18
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 20
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Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 20
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 22
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Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 22
|
|
Tolerability (Mini Mental State Examination [MMSE])
大体时间：Measured at week 24
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Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 24
|
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
大体时间：Measured at baseline
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at baseline
|
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
大体时间：Measured at week 4
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 4
|
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
大体时间：Measured at week 8
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Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 8
|
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
大体时间：Measured at week 12
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Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 12
|
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
大体时间：Measured at week 16
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 16
|
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
大体时间：Measured at week 20
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 20
|
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
大体时间：Measured at week 24
|
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) Measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 24
|
|
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
大体时间：Measured at baseline
|
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
|
Measured at baseline
|
|
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
大体时间：Measured at weeks 12
|
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
|
Measured at weeks 12
|
|
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
大体时间：Measured at weeks 24
|
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
|
Measured at weeks 24
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at baseline
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at baseline
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 2
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 2
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 4
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 4
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 6
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 6
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 8
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 8
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 10
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 10
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 12
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 12
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 14
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 14
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 16
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 16
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 18
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 18
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 20
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
|
Measured at week 20
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 22
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Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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Measured at week 22
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Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
大体时间：Measured at week 24
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Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
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Measured at week 24
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合作者和调查者
调查人员
- 首席研究员：Charles Kellner, MD、Icahn School of Medicine at Mount Sinai
出版物和有用的链接
一般刊物
- Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. doi: 10.1001/archpsyc.63.12.1337.
- Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. doi: 10.1001/jama.285.10.1299.
- Lisanby SH, McClintock SM, McCall WV, Knapp RG, Cullum CM, Mueller M, Deng ZD, Teklehaimanot AA, Rudorfer MV, Bernhardt E, Alexopoulos G, Bailine SH, Briggs MC, Geduldig ET, Greenberg RM, Husain MM, Kaliora S, Latoussakis V, Liebman LS, Petrides G, Prudic J, Rosenquist PB, Sampson S, Tobias KG, Weiner RD, Young RC, Kellner CH; Prolonging Remission in Depressed Elderly (PRIDE) Work Group. Longitudinal Neurocognitive Effects of Combined Electroconvulsive Therapy (ECT) and Pharmacotherapy in Major Depressive Disorder in Older Adults: Phase 2 of the PRIDE Study. Am J Geriatr Psychiatry. 2022 Jan;30(1):15-28. doi: 10.1016/j.jagp.2021.04.006. Epub 2021 May 17.
- Lisanby SH, McClintock SM, Alexopoulos G, Bailine SH, Bernhardt E, Briggs MC, Cullum CM, Deng ZD, Dooley M, Geduldig ET, Greenberg RM, Husain MM, Kaliora S, Knapp RG, Latoussakis V, Liebman LS, McCall WV, Mueller M, Petrides G, Prudic J, Rosenquist PB, Rudorfer MV, Sampson S, Teklehaimanot AA, Tobias KG, Weiner RD, Young RC, Kellner CH; CORE/PRIDE Work Group. Neurocognitive Effects of Combined Electroconvulsive Therapy (ECT) and Venlafaxine in Geriatric Depression: Phase 1 of the PRIDE Study. Am J Geriatr Psychiatry. 2020 Mar;28(3):304-316. doi: 10.1016/j.jagp.2019.10.003. Epub 2019 Oct 12.
- McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Youssef NA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of continuation electroconvulsive therapy on quality of life in elderly depressed patients: A randomized clinical trial. J Psychiatr Res. 2018 Feb;97:65-69. doi: 10.1016/j.jpsychires.2017.11.001. Epub 2017 Nov 16.
- McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Riley MA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of a Course of Right Unilateral Ultrabrief Pulse Electroconvulsive Therapy Combined With Venlafaxine on Insomnia Symptoms in Elderly Depressed Patients. J Clin Psychiatry. 2018 Mar/Apr;79(2):16m11089. doi: 10.4088/JCP.16m11089.
- McCall WV, Lisanby SH, Rosenquist PB, Dooley M, Husain MM, Knapp RG, Petrides G, Rudorfer MV, Young RC, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Riley MA, McCloud L, Kellner CH; CORE/PRIDE Work Group. Effects of a right unilateral ultrabrief pulse electroconvulsive therapy course on health related quality of life in elderly depressed patients. J Affect Disord. 2017 Feb;209:39-45. doi: 10.1016/j.jad.2016.11.003. Epub 2016 Nov 11.
- Kellner CH, McClintock SM, McCall WV, Petrides G, Knapp RG, Weiner RD, Young RC, Greenberg RM, Rudorfer MV, Ahle GM, Liebman LS, Lisanby SH; CORE/PRIDE Group. Brief pulse and ultrabrief pulse right unilateral electroconvulsive therapy (ECT) for major depression: efficacy, effectiveness, and cognitive effects. J Clin Psychiatry. 2014 Jul;75(7):777. doi: 10.4088/JCP.14lr08997. No abstract available.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
lithium and Venlafaxine的临床试验
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USDA Grand Forks Human Nutrition Research CenterCalifornia Polytechnic State University-San Luis Obispo完全的
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Sykehuset Asker og BaerumUllevaal University Hospital完全的
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University of British ColumbiaSocial Sciences and Humanities Research Council of Canada完全的
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Dana-Farber Cancer Institute邀请报名