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Completed Phase 3 Interventional Results available

Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

ClinicalTrials.gov ID: NCT00868452

Public ClinicalTrials.gov record NCT00868452. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 10:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00868452
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Enrollment
348 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2009 (Type not available)
Primary completion
Dec 2011 (Actual)
Completion
Jan 2012 (Actual)
Last update posted
Apr 17, 2014

2009 – 2012

United States locations

U.S. sites
27
U.S. states
13
U.S. cities
24
Facility City State ZIP Site status
Woodland International Research Inc. Little Rock Arkansas 72211 —
South Coast Clinical Trials, Inc. Anaheim California 92804 —
Catalina Research Institute Chino California 91710 —
Synergy Escondido Escondido California 92025 —
Collaborative Neuroscience Network Inc.,12772 Valley View Street Garden Grove California 92645 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
University of California at Irvine Medical Center Orange California 92868 —
CNRI - Los Angeles LLC,8309 Telegraph Road Pico Rivera California 90660 —
CNRI - San Diego, LLC San Diego California 92102 —
Stanford University School of Medicine Stanford California 94305 —
University of Colorado Aurora Colorado 80045 —
Depression and Anxiety Disorders Research Institue Tampa Florida 33613 —
American Medical Research Inc.,1200 Harger Road Suite 415 Oak Brook Illinois 60523 —
American Medical Research, Inc., 1200 Harger Road Suite 415 Oak Brook Illinois 60523 —
J. Gary Booker, MD Shreveport Louisiana 71104 —
Sheppard Pratt Health System,6501 North Charles Street Baltimore Maryland 21285 —
Capital Clinical Research,5515 Security Lane, Suite 525 Rockville Maryland 20852 —
Midwest Research Group Saint Charles Missouri 63301 —
Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209 Albuquerque New Mexico 87109 —
Lake Charles Clinical Trials LLC,700 Spring Forest Road Raleigh North Carolina 27609 —
Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125 Raleigh North Carolina 27609 —
University of Cincinnati Cincinnati Ohio 45219 —
Mood Disorders Program-UHCMC Cleveland Ohio 44106 —
MetroHealth System Cleveland Ohio 44122 —
Midwest Clinical research Center, One Elizabeth Place, Suite G-3 Dayton Ohio 45408 —
CRI Worldwide, LLC Philadelphia Pennsylvania 19139 —
FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200 Austin Texas 78756 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00868452, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 17, 2014 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00868452 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →