deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03187769

Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder

A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults With Schizophrenia, Schizophreniform, or Bipolar I Disorder Who Are Early in Their Illness

Sponsor: Alkermes, Inc.

Conditions Bipolar I Disorder Schizophrenia Schizophreniform Disorders
Interventions ALKS 3831 Olanzapine
Updated 25 times since 2017 Last updated: Dec 22, 2022 Started: Jun 8, 2017 Primary completion: Dec 1, 2021 Completion: Jan 3, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03187769, this PHASE3 trial focuses on Bipolar I Disorder and Schizophrenia and remains completed. Sponsored by Alkermes, Inc., it has been updated 25 times since 2017, reflecting substantial change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

~Jul 2017 – ~Sep 2017 · 2 months · monthly snapshot~Sep 2017 – ~Nov 2017 · 2 months · monthly snapshot~Nov 2017 – ~Jan 2018 · 2 months · monthly snapshot~Jan 2018 – ~Mar 2018 · 59 days · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Feb 2019 · 5 months · monthly snapshot~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Jun 2020 · 10 months · monthly snapshot~Jun 2020 – ~Nov 2020 · 5 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Feb 2022 · 4 months · monthly snapshot~Feb 2022 – ~Feb 2023 · 12 months · monthly snapshot~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 8 months · monthly snapshot

Change History

25 versions recorded

  1. Dec 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Feb 2023 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 20 earlier versions

  1. Feb 2022 — Feb 2023 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Oct 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  5. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  6. Jan 2021 — May 2021 [monthly]

    Recruiting PHASE3

  7. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  8. Jun 2020 — Nov 2020 [monthly]

    Recruiting PHASE3

  9. Aug 2019 — Jun 2020 [monthly]

    Recruiting PHASE3

  10. Jun 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  11. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  12. Feb 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  13. Sep 2018 — Feb 2019 [monthly]

    Recruiting PHASE3

  14. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  15. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  16. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  17. Jan 2018 — Mar 2018 [monthly]

    Recruiting PHASE3

  18. Nov 2017 — Jan 2018 [monthly]

    Recruiting PHASE3

  19. Sep 2017 — Nov 2017 [monthly]

    Recruiting PHASE3

  20. Jul 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

    First recorded

Jun 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Alkermes, Inc.
Data source: Alkermes, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Arkhangelsk, Russia , Atlanta, United States , Augusta, United States , Brescia, Italy , Busan, South Korea , Chicago, United States , Cincinnati, United States , Daegu, South Korea , DeSoto, United States , Eugene, United States and 44 more locations