Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Public ClinicalTrials.gov record NCT01284517. 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 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 in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.
Study identification
- NCT ID
- NCT01284517
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 356 participants
Conditions and interventions
Conditions
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
- Nov 2010 (Type not available)
- Primary completion
- Aug 2012 (Actual)
- Completion
- Aug 2012 (Actual)
- Last update posted
- Nov 26, 2013
2010 – 2012
United States locations
- U.S. sites
- 22
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Innovations, Inc. | Costa Mesa | California | 92647 | — |
| Clinical Innovations Inc. | Riverside | California | 92506 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92123 | — |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | — |
| Clinical Innovations inc. | Santa Ana | California | 92705 | — |
| Collaborative Neuroscience Network | Torrance | California | 90502 | — |
| Colorado Clinical Trials Inc. | Highlands Ranch | Colorado | 80130 | — |
| Accurate Clinical Trials | Kissimmee | Florida | 34741 | — |
| Clinical Neuroscience Solutions Inc. | Orlando | Florida | 32806 | — |
| Northwest Behavioral Research Center | Roswell | Georgia | 30076 | — |
| Institute for Behavioral Medicine LLC | Smyrna | Georgia | 30080 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| Village Clinical Research Inc. | New York | New York | 10003 | — |
| Medical & Behavioral Health Research | New York | New York | 10023 | — |
| Zarzar Psychiatric Associates, PLLC | Raleigh | North Carolina | 27607 | — |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | — |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| FutureSearch Clinical Trials, LP | Dallas | Texas | 75231 | — |
| Pillar Clinical Research | Dallas | Texas | 75243 | — |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | — |
| Summit Research Network (Seattle) LLC | Seattle | Washington | 98104 | — |
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 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01284517, 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 Nov 26, 2013 · Synced Oct 18, 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 NCT01284517 live on ClinicalTrials.gov.