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NCT00552760 · ClinicalTrials.gov registry record · Phase 4

Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder

A Phase 4 study, sponsored by Lehigh Valley Hospital.

Completed
Registry status
Phase 4
Development phase
90
Enrollment target

NCT00552760: Completed Phase 4 study, sponsored by Lehigh Valley Hospital.

NCT00552760 is a Phase 4 study that has completed, run by Lehigh Valley Hospital. The registered enrollment target is 90 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00552760, a Phase 4 study, has completed, sponsored by Lehigh Valley Hospital.

COMPLETED
Registry status
Phase 4
Development phase
90 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.

Primary Outcome

Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0-21, higher scores represent more significant sleep disturbance.

Interventions

  • DRUG Placebo
  • DRUG Ramelteon

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2007-11
Est. Completion 2010-05
Phase Phase 4
Lehigh Valley Hospital

16 total trials

What the finished NCT00552760 record still lists

NCT00552760 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00552760 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00552760 about?

NCT00552760 is a clinical study titled "Ramelteon for the Treatment of Insomnia and Mood Stability in Patients With Euthymic Bipolar Disorder". The purpose of this study is to determine whether treating sleep difficulties in patients with bipolar disorder also improves their mood stability.

What is the current status of trial NCT00552760?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2007-11. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00552760?

The interventions under investigation include: Placebo (DRUG), Ramelteon (DRUG).

Who is sponsoring clinical trial NCT00552760?

This trial is sponsored by Lehigh Valley Hospital, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00552760's enrollment target sits among peer trials

90 886th of 2000 higher than 1,088 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00552760, the US trial registry maintained by the National Library of Medicine. NCT00552760 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.