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A Study of Adjunctive Aripiprazole in Participants With Major Depressive Disorder

StatusCompleted
PhasePhase 3
Started
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Record History

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  1. Lead sponsor: Bristol-Myers Squibb to Otsuka Pharmaceutical Development & Commercialization, Inc.v31 Show 5 more changesShow less
    • Enrollment target: 1200 to 1151
    • Primary and study completion dates: Dec 2006 to Dec 1, 2006
    • Start date: Sep 2004 to Sep 1, 2004
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study title revised
  2. Interventions: Antidepressant + Aripiprazole (Drug), Antidepressant + Placebo (Drug), Antidepressant + Placebo (Drug) to Antidepressant + Aripiprazole (Drug), Antidepressant + Placebo (Drug)
    • Study arms: 3 to 2
    v30
  3. Study completion date: Dec 2006v29
  4. Publications: 10 to 12v28
  5. Re-verified, no change to tracked fieldsv27
Show 25 earlier versionsHide 25 earlier versions
  1. Primary completion date: Dec 2006v26
  2. 2 versions Re-verified since Jun 27, 2008, no change to tracked fieldsv24-v25
  3. Interventions: aripiprazole (Drug), marketed antidepressant (Drug) to Antidepressant + Aripiprazole (Drug), Antidepressant + Placebo (Drug), Antidepressant + Placebo (Drug)
    • Study arms: 0 to 3
    v23
  4. 3 versions Re-verified since Jul 31, 2007, no change to tracked fieldsv20-v22
  5. Trial status: Active, Not Recruiting to Completedv19
  6. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 30 to 28
    v18
  7. Study sites: 31 to 30v17
  8. Site details revised at 1 of 31 sitesv16
  9. Study sites: 32 to 31v15
  10. Study sites: 29 to 32v14
  11. Study sites: 28 to 29v13
  12. Study sites: 29 to 28v12
  13. Study sites: 30 to 29v11
  14. Study sites: 32 to 30v10
  15. Study sites: 34 to 32v9
  16. Study sites: 29 to 34v8
  17. Re-verified, no change to tracked fieldsv7
  18. Study sites: 27 to 29v6
  19. Enrollment target: 1000 to 1200v5
  20. Enrollment target: 1000
    • Start date: Sep 2004
    • Collaborators expanded, about 3 words
    v4
  21. Site details revised at 3 of 27 sitesv3
  22. Study sites: 24 to 27v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Astex Pharmaceuticals
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Depression
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This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive Disorder.
Trial Details
NCT Number NCT00095758
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka America Pharmaceutical
Conditions
(from sponsor)		 Major Depressive Disorder
Related terms Major Depressive Disorder
Enrollment 1,151 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov