NCT01028508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4 depression

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

5.7 years

First QC Date

December 7, 2009

Last Update Submit

April 7, 2017

Conditions

Depression

Keywords

DepressionECTelectroconvulsive therapymood disorderscontinuation ECTcontinuation pharmacotherapygeriatricelderlylithiumvenlafaxine

Outcome Measures

Primary Outcomes (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

    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

    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

    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

    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

    Measured at clinic visits at week 6

  • 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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    Measured at clinic visits at week 24

Secondary Outcomes (42)

  • Level of functioning (SF-36)

    Measured at baseline

  • Level of functioning (SF-36)

    Measured at week 4

  • Level of functioning (SF-36)

    Measured at week 8

  • Level of functioning (SF-36)

    Measured at week 12

  • Level of functioning (SF-36)

    Measured at week 16

  • +37 more secondary outcomes

Study Arms (2)

PHARM

ACTIVE COMPARATOR

lithium and venlafaxine

Drug: lithium and Venlafaxine

STABLE

EXPERIMENTAL

ECT + VLF + Li

Procedure: ECT

Interventions

lithium and VenlafaxineDRUG

Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l

PHARM
ECTPROCEDURE

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

STABLE

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hoboken University Medical Center (MSSM satellite site)

Hoboken, New Jersey, 07030, United States

Location

The Zucker Hillside Hospital North Shore-LIJ Health System

Glen Oaks, New York, 11004, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University/New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (8)

  • 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.

    PMID: 17146008BACKGROUND

  • 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.

    PMID: 11255384BACKGROUND

  • 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.

    PMID: 34074611DERIVED

  • 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.

    PMID: 31706638DERIVED

  • 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.

    PMID: 29195125DERIVED

  • 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.

    PMID: 28742292DERIVED

  • 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.

    PMID: 27886569DERIVED

  • 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.

    PMID: 25093475DERIVED

MeSH Terms

Conditions

DepressionMood Disorders

Interventions

LithiumVenlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Charles Kellner, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

January 1, 2010

Primary Completion

September 1, 2015

Study Completion

March 1, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

US(10)