deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT04030143

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

A Phase 1b, Open-label, Multiple-dose, Randomized, Parallel-arm, Safety, Tolerability, and Pharmacokinetic Trial of Aripiprazole Intramuscular Depot Administered in the Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Interventions Aripiprazole
Updated 14 times since 2019 Last updated: Oct 27, 2023 Started: Aug 1, 2019 Primary completion: Jul 8, 2020 Completion: Jul 8, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Bipolar I Disorder and Schizophrenia and is currently completed. Otsuka Pharmaceutical Development & Commercialization, Inc. leads this study, which shows 14 recorded versions since 2019 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Jan 2020 · 3 months · monthly snapshot~Jan 2020 – ~May 2020 · 4 months · monthly snapshot~May 2020 – ~Sep 2020 · 4 months · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Apr 2022 · 7 months · monthly snapshot~Apr 2022 – ~Dec 2023 · 20 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 9 months · monthly snapshot

Change History

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

    Completed PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. Dec 2023 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  5. Apr 2022 — Dec 2023 [monthly]

    Completed PHASE1_PHASE2

Show 9 earlier versions
  1. Sep 2021 — Apr 2022 [monthly]

    Completed PHASE1_PHASE2

    Phase: PHASE1PHASE1_PHASE2

  2. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE1

  3. Oct 2020 — Jan 2021 [monthly]

    Completed PHASE1

  4. Sep 2020 — Oct 2020 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

  5. May 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE1

  6. Jan 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  7. Oct 2019 — Jan 2020 [monthly]

    Recruiting PHASE1

  8. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  9. Aug 2019 — Sep 2019 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Otsuka Pharmaceutical Development & Commercialization, Inc.
Data source: Otsuka Pharmaceutical Development & Commercialization, Inc.

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