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Study ID: EUCTR 2018-000103-16. We help you review the study, but cannot decide medical eligibility.
CompletedEUCTR 2018-000103-16
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated with Bipolarity type I
This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.
Depression, BipolarityDrug
The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.
Check recruitment and locations
Historical registry record checked by HopeStage on . Registry information can change. Always confirm availability with the research team.
Historical country statuses are shown below. They describe the trial's progress and do not confirm open recruitment.
View the historical EU CTR record
No specific site is confirmed in the available information. Check the official source for locations and remote participation.
Key information made simple
What the source confirms
This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.
What should you check before joining?
Check the official protocol for eligibility, treatment, visits and assessments. If recruitment is listed, confirm with the team that a specific centre is still accepting participants before taking any next step.
Your next step
Participation locations and format are not confirmed in the available information. Ask the research team to confirm the location, any in-person visits, time commitment, costs or compensation, and participation criteria.
Questions to ask before joining
- What are the exact eligibility criteria, and what could exclude someone?
- How many visits, assessments, or follow-ups are expected, and over what period?
- What risks, side effects, practical burdens, or alternatives should be understood first?
- Who should be contacted to confirm locations, timing, compensation, and next steps?
Things to check before joining
Study start dateNot clearly listed
- Recruitment status
- Completed
- Enrollment listed in the registry
- 339
- Sponsor
- SUNOVION PHARMACEUTICALS INC.
- Sponsor type
- Other organization
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
- Locations
- Bulgaria, Poland, Slovakia
- Age range
- Not clearly listed
- Official registry ID
- EUCTR 2018-000103-16
- 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
- Official source
- Official registry link
Want help reviewing this study?
Study ID: EUCTR 2018-000103-16. We help you review the study, but cannot decide medical eligibility.
For you
Participation may contribute to research. Personal benefit is not guaranteed.
Ask the research team to explain the activities, time commitment, and follow-up involved.
Confirm the location and whether remote participation is possible with the research team.
Not medical advice
Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com
Questions about this study
What does the official source confirm?
This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.
Is this study recruiting?
The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.
How can I check the participation requirements?
Check the official protocol for the criteria, treatment and planned assessments. The research team must confirm visits, risks, open centres and your eligibility.
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This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.