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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02832037

Run by

Boehringer Ingelheim

People needed

509

Starts

2016-07-25

Expected to finish

2020-01-29

Last updated by the study team

2021-02-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients must exhibit reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures, in the investigator´s opinion
• Patients must have an identified informant who will be consistent throughout the study.
• Further inclusion criteria apply

You may not qualify if…

• 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
• Treatment with medical devices (e.g. Transcranial Magnetic Stimulation (TMS), neurofeedback) for any psychiatric condition within the last 3 months prior to randomisation
• Patients taking strong or moderate Cytochrome P450 (CYPA4) inhibitors or inducers within the last 30 days prior to randomization
• Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to randomisation
• Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent) prior to randomisation
• Known history of Human Immunodeficiency Virus (HIV) infection and/or a positive result for ongoing Hepatitis B or C infection on the Visit 1 central lab report
• Hemoglobin less than 120 g/L (12g/dL) in men or 115 g/L (11.5 g/dL) in women
• History of hemoglobinopathy such as thalassemia major or sickle-cell anemia
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial or men who are able to father a child, unwilling to be abstinent or use adequate contraception for the duration of the study participation and for at least 28 days after treatment has ended
• Significant history of drug abuse disorder (including alcohol) within the last 6 months prior to informed consent or a positive urine drug screen at screening (except for Benzodiazepines taken according to prescription and as an ongoing, stable regimen)
• Further exclusion criteria apply

Where it is running

• 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
• Lake Charles Clinical Trials LLC — Lake Charles, Louisiana, United States
• Michigan Clinical Research Institute PC — Ann Arbor, Michigan, United States
• Mid-America Clinical Research, LLC — St Louis, Missouri, United States
• University at Buffalo, The State University of New York — Buffalo, New York, United States
• Neurobehavioral Research, Inc. — Cedarhurst, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• North Carolina Psychiatric Research Center — Raleigh, North Carolina, United States
• Midwest Clinical Research — Dayton, Ohio, United States
• InSite Clinical Research — DeSoto, Texas, United States
• Psychiatric and Behavioral Solutions, LLC — Salt Lake City, Utah, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Medical University of Innsbruck — Innsbruck, Austria
• AKH - Medical University of Vienna — Vienna, Austria
• Dr. Alexander McIntyre Inc. — Penticton, British Columbia, Canada
• The Medical Arts Health Research Group — Vancouver, British Columbia, Canada
• Collaborative Neuroscience Network, LLC (CNS) — Garden Grove, California, United States

Full record on ClinicalTrials.gov

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