A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

StatusCompleted
PhasePhase 4
Started

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Record History

The 50 most recent of 136 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Jul 2009 to Jul 1, 2009
    • Start date: Dec 2005 to Dec 1, 2005
    v136
  2. Lead sponsor: Bristol-Myers Squibb to Otsuka Pharmaceutical Development & Commercialization, Inc.v135
  3. Secondary endpoints: details revised at 2 of 16 entriesv134
  4. Results first posted: Oct 20, 2010
    • Enrollment target: 349 to 1169
    • Primary endpoint revised
    • Secondary endpoints: 3 to 16
    v133
  5. 3 versions Re-verified since Apr 13, 2010, no change to tracked fieldsv130-v132
Show 43 earlier versionsHide 43 earlier versions
  1. Study sites revised (66)v129
  2. 2 versions Re-verified since Mar 4, 2010, no change to tracked fieldsv127-v128
  3. Study sites: 1 to 66v126
  4. 5 versions Re-verified since Nov 16, 2009, no change to tracked fieldsv121-v125
  5. Study sites: 2 to 1v120
  6. Study sites: 7 to 2v119
  7. Study sites: 9 to 7v118
  8. Study sites: 15 to 9v117
  9. Re-verified, no change to tracked fieldsv116
  10. Study sites: 14 to 15v115
  11. Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 350 to confirmed 349
    • Study sites: 13 to 14
    v114
  12. Study sites: 16 to 13v113
  13. Study sites: 15 to 16v112
  14. Study sites: 17 to 15v111
  15. 2 versions Re-verified since May 6, 2009, no change to tracked fieldsv109-v110
  16. Study sites: 19 to 17v108
  17. Study sites: 20 to 19v107
  18. Primary and study completion dates: Aug 2009 to Jul 2009v106
  19. Study sites: 21 to 20v105
  20. Study sites: 24 to 21v104
  21. Study sites: 25 to 24
    • Primary and study completion dates: Jul 2009 to Aug 2009
    v103
  22. Study sites: 26 to 25v102
  23. 3 versions Re-verified since Dec 22, 2008, no change to tracked fieldsv99-v101
  24. Study sites: 27 to 26v98
  25. Re-verified, no change to tracked fieldsv97
  26. Study sites: 29 to 27v96
  27. Re-verified, no change to tracked fieldsv95
  28. Study sites: 31 to 29v94
  29. Enrollment target: 1170 to 350
    • Study sites: 32 to 31
    v93
  30. Study sites: 34 to 32v92
  31. Study sites: 35 to 34v91
  32. Re-verified, no change to tracked fieldsv90
  33. Study sites: 39 to 35v89
  34. Re-verified, no change to tracked fieldsv88
  35. Study sites: 43 to 39v87
  • 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.
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
Trial Details
NCT Number NCT00277212
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators: Otsuka America Pharmaceutical
Conditions
(from sponsor)		 Bipolar Disorder
Related terms Bipolar Disorder
Enrollment 1,169 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov