Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder
Public ClinicalTrials.gov record NCT01677182. 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, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated With Bipolar 1 Disorder in Adult Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.
Study identification
- NCT ID
- NCT01677182
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 535 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
- Aug 2012 (Type not available)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Sep 2014 (Actual)
- Last update posted
- Mar 16, 2016
2012 – 2014
United States locations
- U.S. sites
- 41
- U.S. states
- 15
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Anaheim | California | — | — |
| Not listed | Glendale | California | — | — |
| Not listed | Imperial | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Oakland | California | — | — |
| Not listed | Oceanside | California | — | — |
| Not listed | Pico Rivera | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Stanford | California | — | — |
| Not listed | Hartford | Connecticut | — | — |
| Not listed | Coral Springs | Florida | — | — |
| Not listed | Deerfield Beach | Florida | — | — |
| Not listed | Gainesville | Florida | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Maitland | Florida | — | — |
| Not listed | Oakland Park | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | West Palm Beach | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Joliet | Illinois | — | — |
| Not listed | Naperville | Illinois | — | — |
| Not listed | Oak Brook | Illinois | — | — |
| Not listed | Lafayette | Indiana | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Staten Island | New York | — | — |
| Not listed | The Bronx | New York | — | — |
| Not listed | Avon Lake | Ohio | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Garfield Heights | Ohio | — | — |
| Not listed | Mason | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Bothell | Washington | — | — |
| Not listed | Spokane | Washington | — | — |
| Not listed | Waukesha | Wisconsin | — | — |
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 63 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01677182, 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 Mar 16, 2016 · Synced Oct 27, 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 NCT01677182 live on ClinicalTrials.gov.