Loading clinical trials...

Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

A Phase II Randomised, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 425809 Once Daily Over 12 Week Treatment Period in Patients With Schizophrenia

NCT02832037•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women who are 18-50 years (inclusive) of age at time of consent
•Established schizophrenia with the following clinical features:
•* Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomisation
•* Medically stable over the prior 4 weeks and psychiatrically stable without symptom exacerbation within 3 months prior to randomisation
•* patients who have no more than a moderate severe rating on the Positive and Negative Symptom Scale (PANSS) positive items P1, P3-P7 and no more than a moderate rating on the PANSS positive item P2
•Current antipsychotic and concomitant psychotropic medications as assessed at Visit 1 must meet the criteria below:
•* patients may have up to 2 antipsychotics (typical and/or atypical)
•* patients must be maintained on current typical and/or atypical antipsychotics other than Clozapine and on current dose for at least 4 weeks prior to randomisation and/or maintained on current long acting injectable antipsychotics and current dose for at least 3 months prior to randomization
•* patients must be maintained on current concomitant psychotropic medications, anticholinergics, antiepileptics and/or lithium for at least 3 months prior to randomisation and on current dose for at least 4 weeks prior to randomisation
•Women of child-bearing potential must be ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly.
+2 more criteria

Exclusion Criteria

•Patients who have a categorical diagnosis of another current major psychiatric disorder
•Diseases of the central nervous system that may impact cognitive test performance
•Movement disorder not currently controlled
•Patients receiving another investigational drug or procedure within 30 days or 6 half-lives (whichever is longer) or recent participation in another trial with any cognitive enhancing therapy
•Recent participation in formal cognitive remediation program
•Recent electroconvulsive therapy
•Patients who have been on BI 409306, encenicline or other investigational drug testing effects on cognition in schizophrenia within the last 6 months prior to randomisation or who have previously been on bitopertin
•Participation in a clinical trial with repeated Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) assessments within the last 6 months
•Patients who required change in ongoing stable benzodiazepine or sleep medication regimen within the last 4 weeks prior to randomisation
•Treatment with Clozapine within 6 months prior to randomisation
+9 more criteria

Locations (81)

Collaborative Neuroscience Network, LLC (CNS)

Garden Grove, California, United States

Synergy San Diego

Lemon Grove, California, United States

NRC Research Institute

Orange, California, United States

Alliance for Wellness

Panorama City, California, United States

CNRI - Los Angeles

Pico Rivera, California, United States

CNRI-San Diego, LLC

San Diego, California, United States

Premier Clinical Research Institute

Miami, Florida, United States

Synexus

Atlanta, Georgia, United States

Atlanta Center

Atlanta, Georgia, United States

Uptown Research Institute

Chicago, Illinois, United States

Key Dates

Start Date

July 25, 2016

Primary Completion Date

December 27, 2019

Completion Date

January 29, 2020

Last Updated

February 24, 2021

Enrollment

509

ACTUAL participants

Conditions

Schizophrenia

Interventions

BI 425809 dose 1

DRUG

BI 425809 dose 2

DRUG

BI 425809 dose 3

DRUG

BI 425809 dose 4

DRUG

Placebo

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

Brain Stimulation to the Hippocampus in Schizophrenia