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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 is a Phase 3 study that was terminated before completion, run by Lindner Center of HOPE. The registered enrollment target is 21 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00585208
The ClinicalTrials.gov registry entry for NCT00585208 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lindner Center of HOPE, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00585208 reports 0 study locations.
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.
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