deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT03503318

Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia (RISE)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Conditions Schizophrenia
Interventions Placebo TV-46000
Updated 31 times since 2018 Last updated: Feb 8, 2023 Started: Apr 27, 2018 Primary completion: Sep 30, 2020 Completion: Dec 3, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03503318, this PHASE3 trial focuses on Schizophrenia and remains completed. Sponsored by Teva Branded Pharmaceutical Products R&D, Inc., it has been updated 31 times since 2018, reflecting substantial change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Oct 2018 · 3 months · monthly snapshot~Oct 2018 – ~Feb 2019 · 4 months · monthly snapshot~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Oct 2019 · 4 months · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Feb 2020 · 3 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Aug 2020 · 2 months · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Jun 2022 · 4 months · monthly snapshot~Jun 2022 – ~Apr 2023 · 10 months · monthly snapshot~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

31 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Apr 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2022 — Apr 2023 [monthly]

    Completed PHASE3

Show 26 earlier versions
  1. Feb 2022 — Jun 2022 [monthly]

    Completed PHASE3

  2. Jan 2022 — Feb 2022 [monthly]

    Completed PHASE3

  3. Sep 2021 — Jan 2022 [monthly]

    Completed PHASE3

  4. Apr 2021 — Sep 2021 [monthly]

    Completed PHASE3

  5. Mar 2021 — Apr 2021 [monthly]

    Completed PHASE3

  6. Feb 2021 — Mar 2021 [monthly]

    Completed PHASE3

  7. Jan 2021 — Feb 2021 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  8. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  9. Nov 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE3

  10. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

  11. Aug 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  12. Jun 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  13. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  14. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  15. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  16. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  17. Nov 2019 — Feb 2020 [monthly]

    Recruiting PHASE3

  18. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  19. Jun 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  20. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  21. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  22. Feb 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  23. Oct 2018 — Feb 2019 [monthly]

    Recruiting PHASE3

  24. Jul 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  25. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  26. May 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Apr 2018

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Teva Branded Pharmaceutical Products R&D, Inc.
Data source: Teva Branded Pharmaceutical Products R&D, Inc.

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