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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 Sep 7, 2026, 2:37 AM 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
Mar 31, 2009
Primary completion
Nov 30, 2011
Completion
Dec 31, 2011
Last update posted
Apr 16, 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 16, 2014 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00868452 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →