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NCT00868699 · ClinicalTrials.gov registry record · Phase 3
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 505
- Enrollment target
NCT00868699: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT00868699 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 505 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00868699, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 505 participants
- Enrollment target
Study Summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
Primary Outcome
Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (
Interventions
- DRUG Placebo
- DRUG lurasidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 505 participants |
| Start Date | 2009-04 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT00868699 record still lists
NCT00868699 is an interventional study that assigns participants to a tested intervention. The registered 505 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 (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00868699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00868699 about?
NCT00868699 is a clinical study titled "Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)". This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
What is the current status of trial NCT00868699?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 505 participants. The study started on 2009-04. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00868699?
The interventions under investigation include: Placebo (DRUG), lurasidone (DRUG).
Who is sponsoring clinical trial NCT00868699?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00868699's enrollment target sits among peer trials
505 742nd of 2000 higher than 1,259 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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