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Short Title: BI 425809 with brain training in patients with schizophrenia
Long 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
EudraCT - 2018-002740-82
ClinicalTrials.gov - NCT03859973
INFORMATION EXTRACTED FROM CLINTRIALS.GOV AND HRA RESEARCH SUMMARIES WEBSITES
The study will recruit 200 participant through 25 sites based between Australia, Canada, France, Ireland. New Zealand, UK and the USA.
Participants are included in the study only once the informed consent has been signed.
There will be an initial screening period where as well as initial assessment for inclusion and exclusion criteria participants will undergo Computerised Brain Training (CCT) for two weeks. Those participants who meet eligibility criteria and comply with the 2 week CCT training will be stratified by age ( age 18-40 and age 41-50) and allocated at random to one of the two study groups for the 12 week treatment period. These groups are active drug (10mg + CCT) or matching placebo + CCT. The treatment period will be followed by a 4 week follow-up period. This follow up period will also be applicable following discontinuation.
The primary objective of this Phase II exploratory trial is to provide Proof of Concept (PoC) data to assess the effect on cognition of oral once daily administration of BI 425809 given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment and adjunctive Computerized Cognitive Training (CCT).
Primary Outcome Measures :
Secondary Outcome Measures :
Schizophrenia Cognition Rating Scale (SCoRS)
Positive and Negative Syndrome Scale (PANSS)
Extracted from Clinicaltrials.gov
◦Patients must be stable on current antipsychotics and concomitant psychotropic medications (e.g. 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 ---Patients on Long-Acting Injectable (LAI) antipsychotics should be on the same medication and dose for at least 3 months prior to randomization.
HRA website entry
Eligible patients will attend 7 clinic based visits over 12 weeks. Screening Visit 1 and 2 and EoT visit may be split across two days at the discretion of the investigator.
During study visits patients will have their medical history recorded, undergo a routine physical examination, vital signs, height and weight measured, have a standard ECG, routine blood and urine tests, blood samples taken for PK analysis and undergo a series of assessment interviews and tests. At-home adjunctive CCT will be used in this study to provide background cognitive stimulation to the patients. Patients’ routine treatment and care plan will remain otherwise unchanged.