ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

ClinicalTrials.gov ID: NCT01358357

Public ClinicalTrials.gov record NCT01358357. 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 May 7, 2026, 12:11 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, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder

Study identification

NCT ID
NCT01358357
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Enrollment
965 participants

Conditions and interventions

Interventions

  • Lurasidone Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
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
May 31, 2011
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015
Last update posted
Sep 6, 2016

2011 – 2015

United States locations

U.S. sites
26
U.S. states
15
U.S. cities
26
Facility City State ZIP Site status
Harmonex Neuroscience Research Dothan Alabama 36303
Behavioral Research Specialists, LLC Glendale California 91206
AXIS Clinical Trials Los Angeles California 90036
Excell Research, Inc. Oceanside California 92056
Stanford University School of Medicine Research Program VA Palo Alto Health Care System Palo Alto California 94304
SF-CARE, Inc. San Francisco California 94117
Neuropsychiatric Research Center of Orange County Santa Ana California 92701
"Stanford University School of Medicine Stanford California 94305
Florida Clinical Research LLC Bradenton Florida 34201
Clinical Neuroscience Solutions, Inc. Jacksonville Florida 32216
Galiz Research Miami Springs Florida 33166
Clinical Neuroscience Solutions Orlando Florida 32806
Atlanta Center for Medical Research Atlanta Georgia 30308
Clinco Terre Haute Indiana 47802
ActivMed Practices & Research Inc. Haverhill Massachusetts 08130
Psych Care Consultants Research St Louis Missouri 63128
Village Clinical Research Inc, New York New York 10003
Finger Lakes Clinical Research Rochester New York 14618
Charak Center for Health and Wellness Garfield Heights Ohio 44125
Cutting Edge Research Groupd Oklahoma City Oklahoma 73116
Suburban Research Associates Media Pennsylvania 19063
Lincoln Research Lincoln Rhode Island 02865
Carolina Clinical Trials, Inc. Charleston South Carolina 29407
Clinical Neuroscience Solutions Inc. Memphis Tennessee 38119
Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center Dallas Texas 75235
R/D Clinical Research, Inc. Lake Jackson Texas 77566

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 79 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01358357, 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 Sep 6, 2016 · Synced May 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01358357 live on ClinicalTrials.gov.

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