This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year
Public ClinicalTrials.gov record NCT03230097. 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 Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 52-week Treatment Period as an Early Intervention in Patients With Attenuated Psychosis Syndrome.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study in people between 16 and 30 years of age who have a specific type of mental illness called attenuated psychosis syndrome (APS). The purpose of this study is to find out whether BI 409306 helps reduce the symptoms of APS. Participants are in the study for 1 year and 2 months. During this time, they visit the study site about 15 times and get about 10 phone calls. Participants are put into 2 groups by chance. They get either BI 409306 or placebo. Placebo tablets look like BI 409306 tablets but do not contain any medicine. Participants take a BI 409306 or placebo tablet two times a day. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether the APS symptoms change. The doctors also check the general health of the participants.
Study identification
- NCT ID
- NCT03230097
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 30 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
- Sep 29, 2017 (Actual)
- Primary completion
- Mar 17, 2021 (Actual)
- Completion
- Apr 7, 2021 (Actual)
- Last update posted
- May 14, 2025
2017 – 2021
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ProScience Research Group | Culver City | California | 90230 | — |
| University of California San Diego | San Diego | California | 92103 | — |
| PRIME Clinic | New Haven | Connecticut | 06519 | — |
| University of Florida College of Medicine | Jacksonville | Florida | 32209 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Michigan Clinical Research Institute PC | Ann Arbor | Michigan | 48105 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Cherry Health | Grand Rapids | Michigan | 49503 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| Altea Research Institute | Las Vegas | Nevada | 89102 | — |
| Center For Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| New York State Psychiatric Institute | New York | New York | 10032 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| PeaceHealth Medical Group | Eugene | Oregon | 97401 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| University Hills Clinical Research | Irving | Texas | 75062 | — |
| Psychiatric and Behavioral Solutions, LLC | Salt Lake City | Utah | 84105 | — |
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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03230097, 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 14, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03230097 live on ClinicalTrials.gov.