A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).
Public ClinicalTrials.gov record NCT05227209. 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 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression). Participants in the study will receive the drug being studied. This study is accepting male and female participants between 18 and 65 years old who have completed Study SEP380-301. This study will be conducted in approximately 90 study centers worldwide. The treatment duration for this study is one (1) year.
Study identification
- NCT ID
- NCT05227209
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 64 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 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 17, 2022 (Actual)
- Primary completion
- Nov 17, 2023 (Actual)
- Completion
- Nov 17, 2023 (Actual)
- Last update posted
- Feb 21, 2025
2022 – 2023
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Huntsville Regional Medical Campus | Huntsville | Alabama | 35801 | — |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | — |
| Sun Valley Research Center | Imperial | California | 92251 | — |
| Clinical innovations, Inc. | Riverside | California | 92506 | — |
| Collaborative Neuroscience Research, LLC | Torrance | California | 90502 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| Premier Clinical Research Institute, Inc | Miami | Florida | 33122 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| Atlanta Behavioral Research, LLC | Atlanta | Georgia | 30338 | — |
| Psych Atlanta, P.C. | Marietta | Georgia | 30060 | — |
| AMR Conventions Research | Warrenville | Illinois | 60555 | — |
| St. Charles Psychiatric Associates / Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | — |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Richmond Behavioral Associates ERG Clinical Research - New York PLLC | Staten Island | New York | 10312 | — |
| New Hope Clinical Research | Charlotte | North Carolina | 28211 | — |
| Quest Therapeutics of Avon Lake | Avon Lake | Ohio | 44012 | — |
| Neuro-Behavioral Clinical Research, Inc | North Canton | Ohio | 44720 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Lehigh Center for Clinical Research, LLC | Allentown | Pennsylvania | 18104 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| UTHealth Science Center at Houston | Houston | Texas | 77054 | — |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | — |
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 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05227209, 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 Feb 21, 2025 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05227209 live on ClinicalTrials.gov.