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Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2029 → Jul 2030
See other at-risk trials from Bausch Health Americas, Inc.

Record History

  1. Notable Primary completion pushed from Jul 2029 to Jul 2030 Start date: Jun 2026 to Jul 1, 2027 · Completion pushed from Dec 2029 to Dec 2030 · Eligibility criteria expanded, about 17 words · 1 more Show 4 more changesShow less
    • Start date: Jun 2026 to Jul 1, 2027
    • Completion pushed from Dec 2029 to Dec 2030
    • Eligibility criteria expanded, about 17 words
    • Study description expanded, about 10 words
  2. Notable Primary completion date: Nov 2024 to Jul 2029 Start date: Jun 2023 to Jun 2026 · Enrollment target: 200 to 246 · Study sites: 1 to 0 · 1 morev10 Show 4 more changesShow less
    • Start date: Jun 2023 to Jun 2026
    • Enrollment target: 200 to 246
    • Study sites: 1 to 0
    • Completion date: Nov 2024 to Dec 2029
  3. Notable Start date: Oct 2022 to Jun 2023v9
  4. Notable Start date: Nov 2021 to Oct 2022v8
  5. Notable Primary and study completion dates: Apr 2024 to Nov 2024 Start date: Apr 2021 to Nov 2021v7 Show 1 more changeShow less
    • Start date: Apr 2021 to Nov 2021
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary completion date: Nov 30, 2020 to Apr 2024 Start date: Dec 31, 2019 to Apr 2021 · Completion date: Mar 31, 2021 to Apr 2024v6 Show 2 more changesShow less
    • Start date: Dec 31, 2019 to Apr 2021
    • Completion date: Mar 31, 2021 to Apr 2024
  2. Minor Primary completion date: Nov 2020 to Nov 30, 2020 Completion date: Mar 2021 to Mar 31, 2021 · Start date: Dec 2019 to Dec 31, 2019v5 Show 2 more changesShow less
    • Completion date: Mar 2021 to Mar 31, 2021
    • Start date: Dec 2019 to Dec 31, 2019
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Primary completion date: Dec 2017 to Nov 2020 Start date: Jul 2015 to Dec 2019 · Primary endpoint revised · Completion date: Dec 2017 to Mar 2021 · 2 morev3 Show 5 more changesShow less
    • Start date: Jul 2015 to Dec 2019
    • Primary endpoint revised
    • Completion date: Dec 2017 to Mar 2021
    • Eligibility criteria shortened, about 7 words
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  5. Notable Start date: Dec 2014 to Jul 2015v2
  1. Minor 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.
Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety
Trial Details
NCT Number NCT02129751
Lead Sponsor Bausch Health Americas, Inc.
Conditions Major Depressive Disorder
Enrollment 246 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov