A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
Public ClinicalTrials.gov record NCT05169710. 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-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating 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.
A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.
Study identification
- NCT ID
- NCT05169710
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 83 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
- Dec 21, 2021 (Actual)
- Primary completion
- Oct 18, 2023 (Actual)
- Completion
- Oct 18, 2023 (Actual)
- Last update posted
- Oct 3, 2024
2021 – 2023
United States locations
- U.S. sites
- 34
- U.S. states
- 17
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Huntsville Regional Medical Campus | Huntsville | Alabama | 35801 | — |
| Sanro Clinical Research Group LLC | Bryant | Arkansas | 72022 | — |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | — |
| Sun Valley Research Center | Imperial | California | 92251 | — |
| Clinical innovations, Inc. | Riverside | California | 92506 | — |
| Siyan Clinical Research | Santa Rosa | California | 95401 | — |
| Collaborative Neuroscience Research, LLC | Torrance | California | 90502 | — |
| Vertex Research Group | Clermont | Florida | 34711 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| Premier Clinical Research Institute, Inc. | Miami | Florida | 33122 | — |
| Central Miami Medical Institute | Miami | Florida | 33125 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| GCP Clinical Research LLC | Tampa | Florida | 33609 | — |
| Atlanta Behavioral Research, LLC | Atlanta | Georgia | 30338 | — |
| Psych Atlanta, P.C. | Marietta | Georgia | 30060 | — |
| AMR Conventions Research | Warrenville | Illinois | 60555 | — |
| Dept. of Psychiatry & Behavioral Sciences, University of Louisville School of Medicine | Louisville | Kentucky | 40202 | — |
| 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 | — |
| Global Medical Institutes, LLC | Princeton | New Jersey | 08540 | — |
| UB Department of Psychiatry | Buffalo | New York | 14215 | — |
| 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 | — |
| Integrated Clinical Research | St. George | Utah | 84770 | — |
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 55 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05169710, 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 Oct 3, 2024 · Synced Oct 26, 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 NCT05169710 live on ClinicalTrials.gov.