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NCT03230097 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT03230097 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 50 participants.
The verdict
NCT03230097, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG BI 409306
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-09-29 |
| Est. Completion | 2021-04-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03230097
The ClinicalTrials.gov registry entry for NCT03230097 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03230097 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03230097 about?
NCT03230097 is a clinical study titled "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". 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 ...
What is the current status of trial NCT03230097?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2017-09-29. Estimated completion is 2021-04-07.
What interventions are being tested in trial NCT03230097?
The interventions under investigation include: Placebo (DRUG), BI 409306 (DRUG).
Who is sponsoring clinical trial NCT03230097?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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