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Completed Phase 2 Interventional Results available

This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia

ClinicalTrials.gov ID: NCT03859973

Public ClinicalTrials.gov record NCT03859973. 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.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:25 AM EDT

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-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a study in adults with schizophrenia. The study tests whether a medicine called BI 425809 together with brain training improves mental abilities. Participants take study medication once a day for 12 weeks. At the start of the study, the participants are put into 2 groups. It is decided by chance who gets into which group. One group gets BI 425809 tablets every day. The other group gets placebo tablets every day. Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study, all participants do brain training using a computer. The doctors regularly test mental abilities of the participants. The results of the mental ability tests are compared between the groups. The doctors also check the general health of the patients.

Study identification

NCT ID
NCT03859973
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
200 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 50 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
Apr 14, 2019
Primary completion
Sep 29, 2022
Completion
Nov 3, 2022
Last update posted
Nov 17, 2023

2019 – 2022

United States locations

U.S. sites
28
U.S. states
13
U.S. cities
27
Facility City State ZIP Site status
Atria Clinical Research Little Rock Arkansas 72209
Woodland Research Northwest Rogers Arkansas 72758
Encino Hospital Medical Center Encino California 91436
Collaborative Neuroscience Network, LLC (CNS) Garden Grove California 92845
Synergy San Diego Lemon Grove California 91945
Catalina Research Institute, LLC Montclair California 91763
Pacific Research Partners, LLC Oakland California 94607
NRC Research Institute Orange California 92868
CNRI - Los Angeles Pico Rivera California 90660
CNRI-San Diego, LLC San Diego California 92102
Collaborative Neuroscience Network, LLC (CNS) Torrance California 90502
Meridien Research Maitland Florida 32751
Premier Clinical Research Institute Miami Florida 33122
University of Miami Miami Florida 33136
Apalachee Center Tallahassee Florida 32308
Jerome Golden Center for Behavioral Health West Palm Beach Florida 33407
Synexus Atlanta Georgia 30328
Uptown Research Institute Chicago Illinois 60640
Lake Charles Clinical Trials LLC Lake Charles Louisiana 70629
Cherry Health Grand Rapids Michigan 49503
Center for Behavioral Medicine Kansas City Missouri 64108
Synexus Clinical Research US, Inc. New York New York 10017
UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center Raleigh North Carolina 27608
Midwest Clinical Research Dayton Ohio 45417
FutureSearch Trials of Dallas, LP Dallas Texas 75231
Pillar Clinical Research, LLC Richardson Texas 75080
Office of Dr. Aqeel Hashmi, MD, PA Richmond Texas 77407
Northwest Clinical Research Center Bellevue Washington 98007

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 22 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03859973, 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 Nov 17, 2023 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03859973 live on ClinicalTrials.gov.

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