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NCT00585208 · ClinicalTrials.gov registry record · Phase 3
Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance
A Phase 3 study, sponsored by Lindner Center of HOPE.
- Terminated
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT00585208: Clinical Trial Phase 3 study, sponsored by Lindner Center of HOPE.
NCT00585208 is a Phase 3 study that was terminated before completion, run by Lindner Center of HOPE. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00585208, a Phase 3 study, was terminated before completion, sponsored by Lindner Center of HOPE.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this research study is to evaluate the safety and efficacy of ramelteon (Rozerem™) as an add-on treatment for sleep problems in patients with bipolar disorder. This study will determine whether or not the addition of ramelteon to ongoing medication(s) for bipolar disorder is useful in improving sleep.
Interventions
- DRUG Placebo
- DRUG Ramelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
Why NCT00585208 stopped before completion
NCT00585208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00585208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00585208 about?
NCT00585208 is a clinical study titled "Add-On Ramelteon in Bipolar I Disorder With Clinically Significant Sleep Disturbance". The purpose of this research study is to evaluate the safety and efficacy of ramelteon (Rozerem™) as an add-on treatment for sleep problems in patients with bipolar disorder. This study will determine whether or not the addition of ramelteon to ongoing medication(s) for bipolar disorder is useful in...
What is the current status of trial NCT00585208?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2007-12. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00585208?
The interventions under investigation include: Placebo (DRUG), Ramelteon (DRUG).
Who is sponsoring clinical trial NCT00585208?
This trial is sponsored by Lindner Center of HOPE, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00585208's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 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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