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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 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 490 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01467700
The ClinicalTrials.gov registry entry for NCT01467700 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 490 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01467700 reports 0 study locations.
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.
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