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NCT01467700 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 490
- Enrollment target
NCT01467700: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT01467700 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 490 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01467700, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 490 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult participants with acute depressive episodes associated with Bipolar I disorder.
Primary Outcome
The change between MADRS score at week 6 relative to Baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. A mixed measures repeated measures (MMRM) model was used for anal
Interventions
- DRUG Placebo
- DRUG Ramelteon SL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
Why NCT01467700 stopped before completion
NCT01467700 is an interventional study that assigns participants to a tested intervention. The registered 490 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 (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01467700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01467700 about?
NCT01467700 is a clinical study titled "Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder". The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult participants with acute depressive episodes associated with Bipolar I disorder.
What is the current status of trial NCT01467700?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 490 participants. The study started on 2011-12. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01467700?
The interventions under investigation include: Placebo (DRUG), Ramelteon SL (DRUG).
Who is sponsoring clinical trial NCT01467700?
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 NCT01467700's enrollment target sits among peer trials
490 782nd of 2000 higher than 1,218 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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