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NCT00868452 · ClinicalTrials.gov registry record · Phase 3
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
A Phase 3 study of Bipolar Depression, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 348
- Enrollment target
- 20
- Study locations
NCT00868452: Completed Phase 3 study of Bipolar Depression, sponsored by Sumitomo Pharma America.
NCT00868452 is a Phase 3 study of Bipolar Depression that has completed, run by Sumitomo Pharma America. The registered enrollment target is 348 participants, above the 204-participant average among 29 other Bipolar Depression trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00868452, a Phase 3 study of Bipolar Depression, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 348 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.
Primary Outcome
MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.
Conditions Studied
Interventions
- DRUG lurasidone + (lithium or divalproex)
- DRUG Placebo + (lithium or divalproex)
Study Locations (20)
California
- South Coast Clinical Trials, Inc. - Anaheim
- Catalina Research Institute - Chino
- Synergy Escondido - Escondido
- Collaborative Neuroscience Network Inc.,12772 Valley View Street - Garden Grove
- Cedars-Sinai Medical Center - Los Angeles
- University of California at Irvine Medical Center - Orange
- CNRI - Los Angeles LLC,8309 Telegraph Road - Pico Rivera
- CNRI - San Diego, LLC - San Diego
- Stanford University School of Medicine - Stanford
Illinois
- American Medical Research Inc.,1200 Harger Road Suite 415 - Oak Brook
- American Medical Research, Inc., 1200 Harger Road Suite 415 - Oak Brook
Maryland
- Sheppard Pratt Health System,6501 North Charles Street - Baltimore
- Capital Clinical Research,5515 Security Lane, Suite 525 - Rockville
Arkansas
- Woodland International Research Inc. - Little Rock
Colorado
- University of Colorado - Aurora
Florida
- Depression and Anxiety Disorders Research Institue - Tampa
Louisiana
- J. Gary Booker, MD - Shreveport
Missouri
- Midwest Research Group - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2009-04 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT00868452 record still lists
NCT00868452 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, above the 204-participant average among 29 other Bipolar Depression trials with a reported enrollment target (71% higher).
The record links to 1 condition, with Bipolar Depression appearing as the primary indexed condition, and to 2 interventions - of which lurasidone + (lithium or divalproex) is the first listed.
NCT00868452 names 20 study sites across 10 states, led by California, Illinois, Maryland.
Frequently Asked Questions
What is clinical trial NCT00868452 about?
NCT00868452 is a clinical study titled "Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)". This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.
What is the current status of trial NCT00868452?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 348 participants. The study started on 2009-04. Estimated completion is 2012-01.
What conditions does trial NCT00868452 study?
This clinical trial studies the following conditions: Bipolar Depression.
What interventions are being tested in trial NCT00868452?
The interventions under investigation include: lurasidone + (lithium or divalproex) (DRUG), Placebo + (lithium or divalproex) (DRUG).
Who is sponsoring clinical trial NCT00868452?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00868452 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00868452's enrollment target sits among peer trials
348 10th of 29 higher than 20 of 29 other Bipolar Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Depression 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
-
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
RECRUITING · Phase 3
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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
RECRUITING · Phase 3
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Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
COMPLETED · Phase 3
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Pediatric Open-Label Extension Study
COMPLETED · Phase 3
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Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
COMPLETED · Phase 3
-
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
COMPLETED · Phase 3
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