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

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

NCT03859973•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed and dated written informed consent in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
•Male or female patients who are 18-50 years (inclusive) of age at time of consent.
•Established schizophrenia (as per DSM-5) with the following clinical features:
•* Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomization
•* Psychiatrically stable without symptom exacerbation within 3 months prior to randomization
•* PANSS score ≤ 5 on positive items P1, P3-P7 and ≤ 4 on positive item P2 at Visit 1, and confirmed at Visit 2
•Patients must be on stable antipsychotic treatment; also, current antipsychotic medications and concomitant anticholinergics, antiepileptics, lithium and allowed antidepressants must meet the criteria below:
•* Patients must take 1 and may take up to 2 antipsychotics (typical and/or atypical), except for clozapine
•* Patients must be stable on current antipsychotics, anticholinergics, antiepileptics, lithium and allowed antidepressants for at least 3 months prior to randomization and be on current dose for at least 30 days prior to randomization o Patients on Long-Acting Injectable (LAI) antipsychotics should be on the same medication and dose for at least 3 months prior to randomization
•Women of childbearing potential (WOCBP)2 must be ready and able to use highly effective methods of birth control per Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2)) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in Section 4.2.2.3. Such methods should be used throughout the trial, and for a period of at least 35 days after last trial drug intake, and the patient must agree to periodic pregnancy testing during participation in the trial.
+3 more criteria

Exclusion Criteria

•Patients who have a categorical diagnosis of another current major psychiatric disorder on the Mini-International Neuropsychiatric Interview (M.I.N.I.).
•Diseases of the central nervous system (CNS) that may impact the assessment of the cognitive tests as per investigator's opinion. A movement disorder due to antipsychotic treatment not currently controlled with anti- EPS treatment or another movement disorder (e.g. Parkinson´s disease).
•Patients with a history of participating in any formal cognitive remediation program for 10 or more training sessions.
•Patients who were treated with any of the following medications within the last 6 months prior to randomization:
•* Bitopertin, BI 409306, encenicline or other investigational drug testing effects on cognition in schizophrenia
•* Clozapine (atypical antipsychotic medication)
•* Sarcosine, cycloserine, serine and glycine
•* Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
•* Tricyclic antidepressants
•Patients receiving any other investigational drug (other than a potential cognitive enhancing drug) within 30 days or 6 half-lives (whichever is longer) prior to randomization. For investigational LAI antipsychotics, the last injection must be at least 3 months or two administration cycles (i.e. 6 months if administration is every 3 months) prior to randomization, whichever is longer.
+3 more criteria

Locations (50)

Atria Clinical Research

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

Encino Hospital Medical Center

Encino, California, United States

Collaborative Neuroscience Network, LLC (CNS)

Garden Grove, California, United States

Synergy San Diego

Lemon Grove, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Pacific Research Partners, LLC

Oakland, California, United States

NRC Research Institute

Orange, California, United States

CNRI - Los Angeles

Pico Rivera, California, United States

CNRI-San Diego, LLC

San Diego, California, United States

Key Dates

Start Date

April 15, 2019

Primary Completion Date

September 30, 2022

Completion Date

November 4, 2022

Last Updated

November 18, 2023

Enrollment

200

ACTUAL participants

Conditions

Schizophrenia

Interventions

BI 425809

DRUG

Placebo

DRUG

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

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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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: November 18, 2023Data 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

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

Inclusion Criteria

Exclusion Criteria

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

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