Prolonging Remission in Depressed Elderly (PRIDE) (PRIDE)

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: lithium and Venlafaxine; Procedure: ECT

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.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Hoboken, New Jersey, United States, 07030
      • Hoboken University Medical Center (MSSM satellite site)
  • New York
    • Glen Oaks, New York, United States, 11004
      • The Zucker Hillside Hospital North Shore-LIJ Health System
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10032
      • Columbia University/New York State Psychiatric Institute
    • White Plains, New York, United States, 10605
      • Weill Cornell Medical College
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of functioning (SF-36)	Level of functioning (SF-36) measured at baseline and weeks 4, 8, 12, 16, 20, 24	Measured at baseline
Level of functioning (SF-36)	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)	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)	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)	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)	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)	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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])	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	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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 24

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Charles Kellner, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Depression; elderly; lithium; geriatric; mood disorders; ECT; electroconvulsive therapy; continuation ECT; continuation pharmacotherapy; venlafaxine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: GCO 09-0429; U01MH055495 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No