A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression
Public ClinicalTrials.gov record NCT03543410. 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, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
Study identification
- NCT ID
- NCT03543410
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Industry
- Enrollment
- 344 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- SEP-4199 200 mg Drug
- SEP-4199 400 mg Drug
Drug
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
- Jun 25, 2018
- Primary completion
- Apr 22, 2020
- Completion
- Apr 22, 2020
- Last update posted
- May 17, 2023
2018 – 2020
United States locations
- U.S. sites
- 7
- U.S. states
- 4
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CNS Research Science, Inc. | Cerritos | California | 90703 | — |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | — |
| Artemis Insitute for Clinical Research | San Diego | California | 92103 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Eastside Therapeutic Resource dba Core Clinical Research | Everett | Washington | 98201 | — |
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 80 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03543410, 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 May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03543410 live on ClinicalTrials.gov.