Prolonging Remission in Depressed Elderly (PRIDE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01028508
First received: December 7, 2009
Last updated: September 8, 2014
Last verified: September 2014
  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)

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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: March 2015
Estimated Primary Completion Date: March 2015 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028508

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 8, 2014
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:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Lithium
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014