This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
Public ClinicalTrials.gov record NCT01575561. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296
Study identification
- NCT ID
- NCT01575561
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 377 participants
Conditions and interventions
Conditions
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
- Jun 2012 (Type not available)
- Primary completion
- Jul 2015 (Actual)
- Completion
- Jul 2015 (Actual)
- Last update posted
- Aug 22, 2016
2012 – 2015
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 25
| 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 | 93404 | — |
| SF-Care, Inc. | San Francisco | California | 94117 | — |
| Neuropsychiatric Research Center of Orange County | Santa Ana | California | 92701 | — |
| Stanford University School of Medicine | Stanford | California | 93405 | — |
| 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 | — |
| Activ Med Practices & Research | Haverhill | Massachusetts | 08130 | — |
| Psych Care Consultants Research | St Louis | Missouri | 63128 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Charak Clincial Research Center | Garlield Heights | Ohio | 44125 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| Lincoln Research | Lincoln | Rhode Island | 02865 | — |
| Carolina Clinical Trials | 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 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01575561, 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 Aug 22, 2016 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01575561 live on ClinicalTrials.gov.