Prolonging Remission in Depressed Elderly (PRIDE)

Verified by: Mount Sinai School of Medicine, September 2011
First Received: December 7, 2009 | Last Updated: September 13, 2011 | Phase: Phase 4 | Start Date: January 2010
Overall Status: Recruiting | Estimated Enrollment: 322
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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...

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
  • Study Primary Completion Date: April 2014

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: PHARM
    • lithium and venlafaxine
  • Experimental: STABLE
    • ECT + VLF + Li

Outcome Measures for this Clinical Trial

Primary Measures

  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at every week
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 2
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 4
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 5
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 6
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 7
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 8
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 9
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 10
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 11
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 12
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 13
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 14
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 15
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 16
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 17
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 18
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 19
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 20
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 21
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 22
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured by a telephone interview at week 23
      Safety Issue?: No
  • Long-term antidepressant efficacy (Hamilton Rating Scale for Depression)
    • Time Frame: Measured at clinic visits at week 24
      Safety Issue?: No

Secondary Measures

  • Level of functioning (SF-36)
    • Time Frame: Measured at baseline
      Safety Issue?: No
  • Level of functioning (SF-36)
    • Time Frame: Measured at week 4
      Safety Issue?: No
  • Level of functioning (SF-36)
    • Time Frame: Measured at week 8
      Safety Issue?: No
  • Level of functioning (SF-36)
    • Time Frame: Measured at week 12
      Safety Issue?: No
  • Level of functioning (SF-36)
    • Time Frame: Measured at week 16
      Safety Issue?: No
  • Level of functioning (SF-36)
    • Time Frame: Measured at week 20
      Safety Issue?: No
  • Level of functioning (SF-36)
    • Time Frame: Measured at week 24
      Safety Issue?: No
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at baseline
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 2
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 4
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 8
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 10
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 12
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 14
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 16
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 18
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 20
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 22
      Safety Issue?: Yes
  • Tolerability (Mini Mental State Examination [MMSE])
    • Time Frame: Measured at week 24
      Safety Issue?: Yes
  • Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
    • Time Frame: Measured at baseline
      Safety Issue?: Yes
  • Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
    • Time Frame: Measured at week 4
      Safety Issue?: Yes
  • Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
    • Time Frame: Measured at week 8
      Safety Issue?: Yes
  • Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
    • Time Frame: Measured at week 12
      Safety Issue?: Yes
  • Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
    • Time Frame: Measured at week 16
      Safety Issue?: Yes
  • Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
    • Time Frame: Measured at week 20
      Safety Issue?: Yes
  • Tolerability (California Verbal Learning Test [CVLT-II], Autobiographical Memory Interview-Short Form [AMI-SF])
    • Time Frame: Measured at week 24
      Safety Issue?: Yes
  • Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
    • Time Frame: Measured at baseline
      Safety Issue?: Yes
  • Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
    • Time Frame: Measured at weeks 12
      Safety Issue?: Yes
  • Tolerability (Trail Making Tests, DRS-IP and Delis-Kaplan Executive Function System, Verbal Fluency
    • Time Frame: Measured at weeks 24
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at baseline
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 2
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 4
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 6
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 8
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 10
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 12
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 14
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 16
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 18
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 20
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 22
      Safety Issue?: Yes
  • Safety (Udvalg for Kliniske Undersogelser [UKU] Side Effects Rating Scale)
    • Time Frame: Measured at week 24
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Mount Sinai School of Medicine Other

Overall Clinical Trial Officials and Contacts

Charles Kellner, MD Principal Investigator Mount Sinai School of Medicine  

Overall Contact: Kristen Tobias 212-241-6349 kristen.tobias@mssm.edu

Related Publications

References

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.

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.

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01028508

Study ID Number: GCO #09-0429

ClinicalTrials.gov Identifier: NCT01028508

Health Authority: United States: Institutional Review Board

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