Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Public ClinicalTrials.gov record NCT02600507. 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
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
Study identification
- NCT ID
- NCT02600507
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 529 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
- Mar 7, 2016 (Actual)
- Primary completion
- Jul 2, 2020 (Actual)
- Completion
- Jul 2, 2020 (Actual)
- Last update posted
- May 17, 2023
2016 – 2020
United States locations
- U.S. sites
- 42
- U.S. states
- 16
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site | Rogers | Arkansas | — | — |
| Clinical Site | Cerritos | California | — | — |
| Clinical Site | Costa Mesa | California | — | — |
| Clinical Site | Culver City | California | — | — |
| Clinical Site | Garden Grove | California | — | — |
| Clinical Site | Glendale | California | — | — |
| Clinical Site | Lemon Grove | California | — | — |
| Clinical Site | Oceanside | California | — | — |
| Clinical Site | Pico Rivera | California | — | — |
| Clinical Site | Riverside | California | — | — |
| Clinical Site | San Diego | California | — | — |
| Clinical Site | Santa Rosa | California | — | — |
| Clinical Site | Sherman Oaks | California | — | — |
| Clinical Site | Temecula | California | — | — |
| Clinical Site | Jacksonville | Florida | — | — |
| Clinical Site | Lauderhill | Florida | — | — |
| Clinical Site | Miami | Florida | — | — |
| Clinical Site | Orange City | Florida | — | — |
| Clinical Site | Orlando | Florida | — | — |
| Clinical Site | Atlanta | Georgia | — | — |
| Clinical Site | Savannah | Georgia | — | — |
| Clinical Site | Chicago | Illinois | — | — |
| Clinical Site | Lake Charles | Louisiana | — | — |
| Clinical Site | Baltimore | Maryland | — | — |
| Clinical Site | O'Fallon | Missouri | — | — |
| Clinical Site | St Louis | Missouri | — | — |
| Clinical Site | Las Vegas | Nevada | — | — |
| Clinical Site | Berlin | New Jersey | — | — |
| Clinical Site | Cherry Hill | New Jersey | — | — |
| Clinical Site | Toms River | New Jersey | — | — |
| Clinical Site | Cedarhurst | New York | — | — |
| Clinical Site | New York | New York | — | — |
| Clinical Site | Rochester | New York | — | — |
| Clinical Site | Staten Island | New York | — | — |
| Clinical Site | Charlotte | North Carolina | — | — |
| Clinical Site | Cincinnati | Ohio | — | — |
| Clinical Site | Dayton | Ohio | — | — |
| Clinical Site | Garfield Heights | Ohio | — | — |
| Clinical Site | Allentown | Pennsylvania | — | — |
| Clinical Site | Philadelphia | Pennsylvania | — | — |
| Clinical Site | The Woodlands | Texas | — | — |
| Clinical Site | Everett | Washington | — | — |
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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02600507, 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 May 17, 2023 · Synced Oct 22, 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 NCT02600507 live on ClinicalTrials.gov.