Prolonging Remission in Depressed Elderly (PRIDE)
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Purpose
This study will determine whether medications alone or medications and electroconvulsive therapy (ECT) work best to prevent depressive relapse and to improve quality of life for older people with severe mood disorders.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: lithium and Venlafaxine Procedure: ECT |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Prolonging Remission in Depressed Elderly (PRIDE) |
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at every week ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 2 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 4 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 5 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 6 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 7 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 8 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 9 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 10 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 11 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 12 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 13 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 14 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 15 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 16 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 17 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 18 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 19 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 20 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 21 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 22 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured by a telephone interview at week 23 ] [ Designated as safety issue: No ]
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
- Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at clinic visits at week 24 ] [ Designated as safety issue: No ]
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
- Level of functioning (SF-36) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
- Level of functioning (SF-36) [ Time Frame: Measured at week 4 ] [ Designated as safety issue: No ]Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
- Level of functioning (SF-36) [ Time Frame: Measured at week 8 ] [ Designated as safety issue: No ]Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
- Level of functioning (SF-36) [ Time Frame: Measured at week 12 ] [ Designated as safety issue: No ]Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
- Level of functioning (SF-36) [ Time Frame: Measured at week 16 ] [ Designated as safety issue: No ]Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
- Level of functioning (SF-36) [ Time Frame: Measured at week 20 ] [ Designated as safety issue: No ]Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
- Level of functioning (SF-36) [ Time Frame: Measured at week 24 ] [ Designated as safety issue: No ]Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 2 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 4 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 8 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 10 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 12 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 14 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 16 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 18 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 20 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 22 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at week 24 ] [ Designated as safety issue: Yes ]Tolerability (Mini Mental State Examination [MMSE]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
- Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]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
- Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) [ Time Frame: Measured at week 4 ] [ Designated as safety issue: Yes ]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
- Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) [ Time Frame: Measured at week 8 ] [ Designated as safety issue: Yes ]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
- Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) [ Time Frame: Measured at week 12 ] [ Designated as safety issue: Yes ]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
- Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) [ Time Frame: Measured at week 16 ] [ Designated as safety issue: Yes ]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
- Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) [ Time Frame: Measured at week 20 ] [ Designated as safety issue: Yes ]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
- Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) [ Time Frame: Measured at week 24 ] [ Designated as safety issue: Yes ]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
- Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
- Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency [ Time Frame: Measured at weeks 12 ] [ Designated as safety issue: Yes ]Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
- Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency [ Time Frame: Measured at weeks 24 ] [ Designated as safety issue: Yes ]Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 2 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 4 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 6 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 8 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 10 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 12 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 14 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 16 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 18 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 20 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 22 ] [ Designated as safety issue: Yes ]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
- Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at week 24 ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 322 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PHARM
lithium and venlafaxine
|
Drug: lithium and Venlafaxine
Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
|
|
Experimental: STABLE
ECT + VLF + Li
|
Procedure: ECT
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lauren Liebman | 212-241-5288 | lauren.liebman@mssm.edu |
| United States, Georgia | |
| Georgia Regents University | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact: Laryssa McCloud, PhD 706-721-1012 LMcCloud@gru.edu | |
| Principal Investigator: W. Vaughn McCall, MD | |
| United States, Minnesota | |
| Mayo Clinic | Completed |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Jersey | |
| Hoboken University Medical Center (MSSM satellite site) | Completed |
| Hoboken, New Jersey, United States, 07030 | |
| United States, New York | |
| The Zucker Hillside Hospital North Shore-LIJ Health System | Recruiting |
| Glen Oaks, New York, United States, 11004 | |
| Contact: Susan Ray 718-470-8442 sray@lij.edu | |
| Principal Investigator: Georgios Petrides, MD | |
| Columbia University/New York State Psychiatric Institute | Completed |
| New York, New York, United States, 10032 | |
| Icahn School of Medicine at Mount Sinai | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Lauren Liebman 212-241-5288 lauren.liebman@mssm.edu | |
| Principal Investigator: Charles Kellner, MD | |
| Weill Cornell Medical College | Recruiting |
| White Plains, New York, United States, 10605 | |
| Contact: Laurie Davan 914-682-9100 ext 2570 lad9011@med.cornell.edu | |
| Principal Investigator: Robert C Young, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Chris Sikes-Keilp 919-668-1321 cvs6@duke.edu | |
| Principal Investigator: Sarah H Lisanby, MD | |
| Wake Forest University Medical Center | Completed |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Najeeb Ranginwala, MD 214-648-2806 Najeeb.Ranginwala@UTSouthwestern.edu | |
| Principal Investigator: Mustafa M Husain, MD | |
| Principal Investigator: | Charles Kellner, MD | Icahn School of Medicine at Mount Sinai |
More Information
Publications:
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01028508 History of Changes |
| Other Study ID Numbers: | GCO #09-0429, U01 MH055495-01A2 |
| Study First Received: | December 7, 2009 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Depression ECT electroconvulsive therapy mood disorders continuation ECT |
continuation pharmacotherapy geriatric elderly lithium venlafaxine |
Additional relevant MeSH terms:
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Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Lithium Lithium Carbonate Venlafaxine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Antimanic Agents Antidepressive Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Serotonin Agents Antidepressive Agents, Second-Generation |
ClinicalTrials.gov processed this record on May 19, 2013