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A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression

Study acronym: APOLLO
StatusUnknown
PhasePhase 3
Started2018-02-22
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 19, 2024 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features. This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.

Amendment history 1 change detected by DataLookout

2026-09-06
minor
Trial status changed: Recruiting → Unknown
Trial Details
NCT Number NCT03423680
Lead Sponsor Korea Otsuka Pharmaceutical Co., Ltd.
Conditions Depression, Bipolar
Enrollment 390 participants
Start Date 2018-02-22
Primary Completion 2025-11 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-08-19