Clinical trial NCT01028508: Prolonging Remission in Depressed Elderly (PRIDE)
Official title: Prolonging Remission in Depressed Elderly (PRIDE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Depression
ECT
electroconvulsive therapy
mood disorders
continuation ECT
continuation pharmacotherapy
geriatric
elderly
lithium
venlafaxine
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-12-09
Enrollment: 247
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at every week
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 2
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 4
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 5
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 6
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 7
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 8
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 9
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 10
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 11
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 12
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 13
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 14
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 15
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 16
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 17
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 18
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 19
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 20
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 21
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 22
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured by a telephone interview at week 23
measure: Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
timeFrame: Measured at clinic visits at week 24
Secondary outcomes:
measure: Level of functioning (SF-36)
timeFrame: Measured at baseline
measure: Level of functioning (SF-36)
timeFrame: Measured at week 4
measure: Level of functioning (SF-36)
timeFrame: Measured at week 8
measure: Level of functioning (SF-36)
timeFrame: Measured at week 12
measure: Level of functioning (SF-36)
timeFrame: Measured at week 16
measure: Level of functioning (SF-36)
timeFrame: Measured at week 20
measure: Level of functioning (SF-36)
timeFrame: Measured at week 24
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at baseline
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 2
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 4
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 8
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 10
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 12
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 14
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 16
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 18
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 20
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 22
measure: Tolerability (Mini Mental State Examination [MMSE])
timeFrame: Measured at week 24
measure: Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
timeFrame: Measured at baseline
measure: Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
timeFrame: Measured at week 4
measure: Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
timeFrame: Measured at week 8
measure: Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
timeFrame: Measured at week 12
measure: Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
timeFrame: Measured at week 16
measure: Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
timeFrame: Measured at week 20
measure: Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
timeFrame: Measured at week 24
measure: Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
timeFrame: Measured at baseline
measure: Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
timeFrame: Measured at weeks 12
measure: Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
timeFrame: Measured at weeks 24
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at baseline
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 2
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 4
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 6
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 8
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 10
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 12
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 14
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 16
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 18
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 20
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 22
measure: Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
timeFrame: Measured at week 24
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hoboken
country: United States
facility: Hoboken University Medical Center (MSSM satellite site)
state: New Jersey
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital North Shore-LIJ Health System
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University/New York State Psychiatric Institute
state: New York
city: White Plains
country: United States
facility: Weill Cornell Medical College
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Charles Kellner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.