Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) in the Treatment of Acute Depressive Episodes Associated With Bipolar I Disorder in Adult Patients Who Are on Lithium and/or Valproate
Sponsor: Takeda
Terminated
Business Decision; No Safety Concerns
A PHASE3 clinical study on Acute Depressive Episode, this trial is terminated or withdrawn. The trial is conducted by Takeda and has accumulated 8 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
8 versions recorded-
Oct 2025 — Present [monthly]
Terminated PHASE3
-
Sep 2025 — Oct 2025 [monthly]
Terminated PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE3
▶ Show 3 earlier versions
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE3
-
Feb 2017 — Jun 2018 [monthly]
Terminated PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Terminated PHASE3
First recorded
Dec 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Takeda
For direct contact, visit the study record on ClinicalTrials.gov .