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NCT01677182 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 535
- Enrollment target
NCT01677182: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT01677182 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 535 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01677182, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 535 participants
- Enrollment target
Study Summary
To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.
Primary Outcome
The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0(normal) to 6(most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.
Interventions
- DRUG Placebo
- DRUG Ramelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 535 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
Why NCT01677182 stopped before completion
NCT01677182 is an interventional study that assigns participants to a tested intervention. The registered 535 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 (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01677182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01677182 about?
NCT01677182 is a clinical study titled "Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder". To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.
What is the current status of trial NCT01677182?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 535 participants. The study started on 2012-08. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01677182?
The interventions under investigation include: Placebo (DRUG), Ramelteon (DRUG).
Who is sponsoring clinical trial NCT01677182?
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 NCT01677182's enrollment target sits among peer trials
535 702nd of 2000 higher than 1,298 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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