Prolonging Remission in Depressed Elderly (PRIDE) (PRIDE)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
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Georgia
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Augusta, Georgia, Förenta staterna, 30912
- Georgia Regents University
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
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New Jersey
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Hoboken, New Jersey, Förenta staterna, 07030
- Hoboken University Medical Center (MSSM satellite site)
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New York
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Glen Oaks, New York, Förenta staterna, 11004
- The Zucker Hillside Hospital North Shore-LIJ Health System
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New York, New York, Förenta staterna, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Förenta staterna, 10032
- Columbia University/New York State Psychiatric Institute
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White Plains, New York, Förenta staterna, 10605
- Weill Cornell Medical College
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest University Medical Center
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Texas
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Dallas, Texas, Förenta staterna, 75390
- University of Texas Southwestern Medical Center at Dallas
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Tidsram: Measured at every week
|
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
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Tidsram: Measured at clinic visits at week 2
|
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)
Tidsram: Measured at clinic visits at week 4
|
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)
Tidsram: Measured by a telephone interview at week 5
|
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
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Tidsram: Measured at clinic visits at week 6
|
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)
Tidsram: Measured by a telephone interview at week 7
|
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)
Tidsram: 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)
Tidsram: Measured by a telephone interview at week 9
|
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)
Tidsram: Measured at clinic visits at week 10
|
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)
Tidsram: Measured by a telephone interview at week 11
|
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
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Tidsram: Measured at clinic visits at week 12
|
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)
Tidsram: Measured by a telephone interview at week 13
|
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)
Tidsram: Measured at clinic visits at week 14
|
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)
Tidsram: Measured by a telephone interview at week 15
|
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
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Tidsram: Measured at clinic visits at week 16
|
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)
Tidsram: Measured by a telephone interview at week 17
|
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
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Tidsram: Measured at clinic visits at week 18
|
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
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Tidsram: Measured by a telephone interview at week 19
|
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)
Tidsram: Measured at clinic visits at week 20
|
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
|
|
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
Tidsram: 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)
Tidsram: Measured at clinic visits at week 22
|
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)
Tidsram: 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)
Tidsram: Measured at clinic visits at week 24
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Level of functioning (SF-36)
Tidsram: Measured at baseline
|
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at baseline
|
|
Level of functioning (SF-36)
Tidsram: 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)
Tidsram: Measured at week 8
|
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
|
Measured at week 8
|
|
Level of functioning (SF-36)
Tidsram: Measured at week 12
|
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)
Tidsram: Measured at week 16
|
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)
Tidsram: Measured at week 20
|
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)
Tidsram: 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])
Tidsram: 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])
Tidsram: 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])
Tidsram: 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])
Tidsram: Measured at week 8
|
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])
Tidsram: 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])
Tidsram: 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])
Tidsram: Measured at week 14
|
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])
Tidsram: Measured at week 16
|
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])
Tidsram: Measured at week 18
|
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])
Tidsram: Measured at week 20
|
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])
Tidsram: Measured at week 22
|
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])
Tidsram: Measured at week 24
|
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])
Tidsram: 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])
Tidsram: 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])
Tidsram: Measured at week 8
|
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])
Tidsram: Measured at week 12
|
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])
Tidsram: 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])
Tidsram: 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])
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Measured at week 22
|
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 22
|
|
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
Tidsram: 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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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Charles Kellner, MD, Icahn School of Medicine at Mount Sinai
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Beteendesymtom
- Depression
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Psykotropa droger
- Neurotransmittorupptagshämmare
- Membrantransportmodulatorer
- Antidepressiva medel
- Antidepressiva medel, andra generationen
- Serotonin- och noradrenalinåterupptagshämmare
- Venlafaxinhydroklorid
Andra studie-ID-nummer
- GCO 09-0429
- U01MH055495 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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