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Completed

NCT Number: NCT01028508

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Mental Disorders Mood Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Georgia Regents University, Augusta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lithium and Venlafaxine

Drug

Drug: VLF Target dose 225 mg/day Drug: Li Target serum concentration 0.7 mEq/l

ECT

Procedure

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: PRIDE

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Dec 9, 2009
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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