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Prolonging Remission in Depressed Elderly (PRIDE) (PRIDE)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01028508
First received: December 7, 2009
Last updated: April 7, 2017
Last verified: April 2017

December 7, 2009
April 7, 2017
January 2010
September 2015   (Final data collection date for primary outcome measure)
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression) [ Time Frame: Measured at every week ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]

    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 ]
Complete list of historical versions of study NCT01028508 on ClinicalTrials.gov Archive Site
  • Level of functioning (SF-36) [ Time Frame: Measured at baseline ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: Participant
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.
 
Completed
247
March 2016
September 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
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01028508
GCO 09-0429
U01MH055495 ( US NIH Grant/Contract Award Number )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Principal Investigator: Charles Kellner, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
April 2017

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