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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

December 7, 2009
September 8, 2014
January 2010
March 2015   (final data collection date for primary outcome measure)
  • 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

Long-term antidepressant efficacy (Hamilton Rating Scale for Depression [ Time Frame: 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01028508 on ClinicalTrials.gov Archive Site
  • 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
  • Level of functioning (WHODAS-II and SF-36) [ Time Frame: easured at baseline and weeks 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
  • Tolerability (Mini Mental State Examination [MMSE]) [ Time Frame: Measured at baseline, and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 ] [ Designated as safety issue: Yes ]
  • Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF]) [ Time Frame: Measured at baseline and weeks 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: Yes ]
  • Tolerability (Trail Making Test parts A and B,DRS-IP and Delis-Kaplan Executive Function System,Verbal Fluency and Sorting Tests [ Time Frame: Measured at baseline and weeks 12, 24 ] [ Designated as safety issue: Yes ]
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale) [ Time Frame: Measured at baseline and weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Prolonging Remission in Depressed Elderly (PRIDE)
Prolonging Remission in Depressed Elderly (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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Depression
  • Drug: lithium and Venlafaxine
    Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l
  • 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
  • Active Comparator: PHARM
    lithium and venlafaxine
    Intervention: Drug: lithium and Venlafaxine
  • Experimental: STABLE
    ECT + VLF + Li
    Intervention: Procedure: ECT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
322
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01028508
GCO 09-0429, U01 MH055495-01A2
Yes
Mount Sinai School of Medicine
Mount Sinai School of Medicine
National Institute of Mental Health (NIMH)
Principal Investigator: Charles Kellner, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP