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NCT01467713 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 642
- Enrollment target
NCT01467713: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT01467713 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 642 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01467713, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 642 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.
Primary Outcome
The time from randomization to relapse over 12 months double-blind treatment period as determined by the Principal Investigator (PI) or defined by any of the following criteria: depression \[Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥16\]; mania/hypomania \[Young Mania Rating Scale (YMRS) total score ≥14\]; mixed episode \[MADRS score ≥16 and YMRS total score ≥16\]; or, whether participant receives psychiatric hospitalization for bipolar disorder, electroconvulsive therapy (ECT) or
Interventions
- DRUG Placebo
- DRUG Ramelteon SL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 642 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
Why NCT01467713 stopped before completion
NCT01467713 is an interventional study that assigns participants to a tested intervention. The registered 642 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01467713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01467713 about?
NCT01467713 is a clinical study titled "Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder". The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.
What is the current status of trial NCT01467713?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 642 participants. The study started on 2011-12. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01467713?
The interventions under investigation include: Placebo (DRUG), Ramelteon SL (DRUG).
Who is sponsoring clinical trial NCT01467713?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01467713's enrollment target sits among peer trials
642 574th of 2000 higher than 1,426 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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