This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months
Public ClinicalTrials.gov record NCT03351244. 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 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 28-week Treatment Period as Adjunctive Therapy to Antipsychotic Treatment for the Prevention of Relapse in Patients With Schizophrenia.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.
Study identification
- NCT ID
- NCT03351244
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 264 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 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 7, 2017 (Actual)
- Primary completion
- Mar 10, 2021 (Actual)
- Completion
- Mar 31, 2021 (Actual)
- Last update posted
- May 14, 2025
2017 – 2021
United States locations
- U.S. sites
- 32
- U.S. states
- 13
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alea Research | Phoenix | Arizona | 85012 | — |
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | — |
| Collaborative Neuroscience Network, LLC (CNS) | Garden Grove | California | 92845 | — |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | — |
| Synergy East | Lemon Grove | California | 91945 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| Excell Research Inc. | Oceanside | California | 92056 | — |
| Orange County Neuropsychiatric Research Center LLC | Orange | California | 92868 | — |
| Collaborative Neuroscience Network, LLC (CNS) | Torrance | California | 90502 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| Reliable Clinical Research | Hialeah | Florida | 33012 | — |
| Meridien Research | Maitland | Florida | 32751 | — |
| Behavioral Clinical Research, Inc. | North Miami | Florida | 33161 | — |
| Meridien Research | Orlando | Florida | 32810 | — |
| Atlanta Center | Atlanta | Georgia | 30331 | — |
| Alam Medical Research, Inc. | Chicago | Illinois | 60612 | — |
| Lake Charles Clinical Trials LLC | Lake Charles | Louisiana | 70629 | — |
| Clinical Trials of America, LLC | Monroe | Louisiana | 71201 | — |
| Michigan Clinical Research Institute PC | Ann Arbor | Michigan | 48105 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| St. Charles Psychiatric Associates & Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Arch Clinical Trials | St Louis | Missouri | 63125 | — |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | — |
| Altea Research Institute | Las Vegas | Nevada | 89102 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | — |
| New York State Psychiatric Institute | New York | New York | 10032 | — |
| Manhattan Behavioral Medicine PLLC | New York | New York | 10036 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| University Hills Clinical Research | Irving | Texas | 75062 | — |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | — |
| @Health Texas | Richmond | Texas | 77407 | — |
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 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03351244, 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 23, 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 NCT03351244 live on ClinicalTrials.gov.