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Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 14, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Site details revised at 1 of 47 sitesv22
  2. Site details revised at 1 of 47 sitesv21
  3. Site details revised at 2 of 47 sitesv20
  4. Site details revised at 1 of 47 sitesv19
  5. Site details revised at 3 of 47 sitesv18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 44 to 47v17
  2. Study sites: 43 to 44v16
  3. Study sites: 42 to 43v15
  4. Study sites: 44 to 42v14
  5. Study sites: 39 to 44v13
  6. Site details revised at 2 of 39 sitesv12
  7. Study sites: 42 to 39 Eligibility criteria expanded, about 7 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 44 to 42v10
  9. Study sites: 11 to 44v9
  10. Study sites: 10 to 11v8
  11. Study sites: 8 to 10v7
  12. Study sites: 7 to 8v6
  13. Study sites: 5 to 7v5
  14. Study sites: 1 to 5v4
  15. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 2022 to Jun 30, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2022 to Jun 30, 2022
  16. Start date: Apr 2022 to Jun 2022 Primary endpoint revisedv2 Show 1 more changeShow less
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Alkermes
10 trials monitored
See 1 trial at risk
Schizophrenia
685 trials monitored
See 32 trials at risk
Bipolar Disorder
388 trials monitored
See 23 trials at risk
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
Trial Details
NCT Number NCT05303064
Lead Sponsor Alkermes, Inc.
Conditions Schizophrenia, Bipolar I Disorder
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov