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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
247
Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
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
Georgia Regents University
Augusta, Georgia, United States
Mayo Clinic
Rochester, Minnesota, United States
Hoboken University Medical Center (MSSM satellite site)
Hoboken, New Jersey, United States
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at every week
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 2
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 4
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 5
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 6
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The Zucker Hillside Hospital North Shore-LIJ Health System
Glen Oaks, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University/New York State Psychiatric Institute
New York, New York, United States
Weill Cornell Medical College
White Plains, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest University Medical Center
Winston-Salem, North Carolina, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 7
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 8
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 9
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 10
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 11
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 12
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 13
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 14
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 15
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 16
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 17
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 18
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 19
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 20
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 21
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 22
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured by a telephone interview at week 23
Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
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
Time frame: Measured at clinic visits at week 24
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Time frame: Measured at baseline
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Time frame: Measured at week 4
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Time frame: Measured at week 8
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Time frame: Measured at week 12
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Time frame: Measured at week 16
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Time frame: Measured at week 20
Level of functioning (SF-36)
Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24
Time frame: Measured at week 24
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at baseline
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 2
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 4
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 8
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 10
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 12
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 14
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 16
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 18
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 20
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 22
Tolerability (Mini Mental State Examination [MMSE])
Tolerability (Mini Mental State Examination \[MMSE\]) Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24
Time frame: Measured at week 24
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
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
Time frame: Measured at baseline
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
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
Time frame: Measured at week 4
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
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
Time frame: Measured at week 8
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
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
Time frame: Measured at week 12
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
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
Time frame: Measured at week 16
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
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
Time frame: Measured at week 20
Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
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
Time frame: Measured at week 24
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
Time frame: Measured at baseline
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
Time frame: Measured at weeks 12
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency Measured at baseline and weeks 12, 24
Time frame: Measured at weeks 24
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at baseline
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 2
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 4
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 6
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 8
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 10
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 12
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 14
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 16
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 18
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 20
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 22
Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
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
Time frame: Measured at week 24