deltatrials
Completed PHASE3 INTERVENTIONAL 4-arm NCT03573297

A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

Sponsor: AbbVie

Conditions Bipolar I Disorder Depression Mania
Interventions Cariprazine Placebo
Updated 19 times since 2018 Last updated: Sep 27, 2023 Started: Jun 15, 2018 Primary completion: Sep 5, 2022 Completion: Sep 5, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Bipolar I Disorder and Depression and is currently completed. AbbVie leads this study, which shows 19 recorded versions since 2018 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

~Jul 2018 – ~Jul 2019 · 12 months · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Mar 2020 · 6 months · monthly snapshot~Mar 2020 – ~May 2020 · 2 months · monthly snapshot~May 2020 – ~Sep 2020 · 4 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~May 2022 · 8 months · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Oct 2023 · 9 months · monthly snapshot~Oct 2023 – ~Jul 2024 · 9 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 · 5 months · monthly snapshot

Change History

19 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. Oct 2023 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 14 earlier versions

  1. Jan 2023 — Oct 2023 [monthly]

    Completed PHASE3

  2. Sep 2022 — Jan 2023 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Jun 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE3

  4. May 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2021 — May 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  6. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  7. Apr 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  8. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  9. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  10. May 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  11. Mar 2020 — May 2020 [monthly]

    Recruiting PHASE3

  12. Sep 2019 — Mar 2020 [monthly]

    Recruiting PHASE3

  13. Jul 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  14. Jul 2018 — Jul 2019 [monthly]

    Recruiting PHASE3

    First recorded

Jun 2018

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AbbVie
Data source: AbbVie

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

Study Locations

Anaheim, United States , Atlanta, United States , Austin, United States , Beavercreek, United States , Belgrade, Serbia , Bellflower, United States , Berlin, United States , Burgas, Bulgaria , Busan, South Korea , Cedarhurst, United States and 81 more locations