BI 425809 for Schizophrenia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Centro de Investigación y Proyectos en neurociencia CIPNA, Barranquilla, Colombia
Schizophrenia
BI 425809 - Drug
Eligibility
18 - 65
All Sexes
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Study Summary

This study is evaluating whether a medicine called BI 425809 might improve learning and memory in people with schizophrenia.

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Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Schizophrenia

Study Objectives

This trial is evaluating whether BI 425809 will improve 1 primary outcome and 4 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of up to 24 weeks.

Week 26
Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment
Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London (ToL) test
Change from baseline to Week 26 in the adjusted total time in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
up to 24 weeks
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Schizophrenia

Side Effects for

Donepezil Group (Part 1: Treatment B, Test 1)
Nausea
50%
Dizziness
33%
Headache
28%
Vision blurred
28%
Fatigue
17%
Diarrhoea
11%
Malaise
6%
Abnormal dreams
6%
Insomnia
6%
Vomiting
6%
Bone pain
6%
Nasopharyngitis
0%
Dysmenorrhoea
0%
Feeling hot
0%
Back pain
0%
Sleep disorder
0%
Flatulence
0%
Muscle strain
0%
Abdominal discomfort
0%
Dry mouth
0%
Abdominal pain upper
0%
Migraine
0%
Syncope
0%
This histogram enumerates side effects from a completed 2019 Phase 1 trial (NCT03905096) in the Donepezil Group (Part 1: Treatment B, Test 1) ARM group. Side effects include: Nausea with 50%, Dizziness with 33%, Headache with 28%, Vision blurred with 28%, Fatigue with 17%.

Trial Design

2 Treatment Groups

BI 425809
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 586 total participants across 2 different treatment groups

This trial involves 2 different treatments. BI 425809 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

BI 425809
Drug
Placebo
Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 425809
2019
Completed Phase 1
~300

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline and at week 26
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at baseline and at week 26 for reporting.

Closest Location

Richmond Behavioral Associates - Staten Island, NY

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients should have difficulty completing day-to-day activities as determined by the investigator. show original
Patients who are taking any other psychoactive medications (except for anticholinergics) need to continue taking the same drug for at least 12 weeks and on their current dose/ regimen for at least 35 days prior to randomization. show original
A diagnosis of schizophrenia can be made using the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) show original
-- People must be stable both clinically and mentally before they can be prescribed this drug show original
People who have been taking their current antipsychotic medication for 12 weeks and on their current dose for 35 days will be chosen to take part in the study. show original
Women who might be able to have children must use contraception that works very well. show original
The study partner should be someone who interacts with the patient on a regular basis show original
Signed and dated written informed consent.
Patients who are 18-50 years old can choose to consent to be in a study. show original

Patient Q&A Section

What is schizophrenia?

"Schizophrenia is a chronic mental illness in which a person has a disturbed mental function for at least two weeks and that disturbs his or her day to day life. It is a schizophrenia psychosis. A psychosis is a mental disorder in a psychotic schizophrenic. Schizophrenia is divided into psychotic and affective states. It is the psychotic state that most people in prison will experience as a symptom. It is an extremely disabling condition in which all patients seem to suffer from some degree of depression-like symptoms. The disease is characterized by recurrent episodes of psychosis which vary in symptoms ranging from mild to severe psychosis. It is a very serious mental disorder and can bring with it many serious psychological effects." - Anonymous Online Contributor

Unverified Answer

What causes schizophrenia?

"It is likely that schizophrenia is the result of an underlying susceptibility combined with a multiplicity of environmental risk factors. The environmental risk factors may be genetic or environmental and may change and become more complicated with time, so a single factor perspective is likely to conceal a complexity. The role of social and behavioural factors may be particularly under-addressed." - Anonymous Online Contributor

Unverified Answer

How many people get schizophrenia a year in the United States?

"About 5.4 million children in the United States are currently diagnosed with ADHD. Around 5 to 6 million people are diagnosed with schizophrenia annually in the Unites States." - Anonymous Online Contributor

Unverified Answer

What are common treatments for schizophrenia?

"Nearly two-thirds of the patients surveyed used various antipsychotic medications, mostly at lower-than-therapeutic dose. Medications to treat other conditions are also prevalent, especially in female cases. The use of antidepressants is not uncommon, though is less likely to be prescribed for the treatment of schizophrenia than in the general population. About one-third of the cases reported that they saw a psychiatrist and about one-half indicated that they had been diagnosed with depression. Only 15.1% of patients self-reported that they had been diagnosed with schizophrenia and not treated." - Anonymous Online Contributor

Unverified Answer

What are the signs of schizophrenia?

"Hallucinations and delusions are typical neurological symptoms in people with schizophrenia. Other more subtle signs include behavioural changes such as lack of motivation, changing sleep patterns, depression and trouble thinking. These symptoms can begin around the age of 25 years and, in many instances, are not evidently visible in people without schizophrenia. Patients with schizophrenia often report experiencing symptoms such as excessive talking or poor concentration for some as long as 25 years. If one is wondering what the sudden change in a patient is then look for signs of schizophrenia in their family history." - Anonymous Online Contributor

Unverified Answer

Can schizophrenia be cured?

"The possibility exists that with more effective treatment, psychotic symptoms can be eliminated. However, such treatment will never stop all symptom or the underlying deterioration of the brain." - Anonymous Online Contributor

Unverified Answer

Does bi 425809 improve quality of life for those with schizophrenia?

"This placebo-controlled, double-blind, randomized, parallel group study suggests that bi 425809 at either 0.25 or 0.5 mg/kg does not improve the QoL of people with schizophrenia" - Anonymous Online Contributor

Unverified Answer

Does schizophrenia run in families?

"Familial risk of a first episode of schizophrenia is weak. In a number of case-control studies, some subjects with a first episode of schizophrenia show evidence of a genetic relationship to their relatives. The majority of these studies have been limited by small sample size. We have shown that in a large population based sample, such clustering is not strongly associated with schizophrenia." - Anonymous Online Contributor

Unverified Answer

What is the latest research for schizophrenia?

"Recent publications have outlined some of the most important discoveries in schizophrenia research: that it is a spectrum/continuum, that it is on a biological model, that there are important biological mechanisms for brain development abnormalities in schizophrenia. There is also new work suggesting that schizophrenia is a disconnection syndrome, that it is influenced by both genetics and the environment, and that it may be genetically heterogenous. There have also been studies which support earlier findings that schizophrenia is associated with significant delays in brain growth. There are many new discoveries happening and a small but growing body of evidence that should be added to the growing literature in this area as they emerge." - Anonymous Online Contributor

Unverified Answer

Is bi 425809 typically used in combination with any other treatments?

"When used at lower doses, BBKG appears to have better retention rates on cognitive and behavioural measures than the benzodiazepine bi 425809. Both drugs have similar efficacy in reducing psychotic symptoms." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of schizophrenia?

"The present findings support the psychopharmakologic model of schizophrenia as an explanation for its causation. The importance of the early diagnosis of autism spectrum disorders remains." - Anonymous Online Contributor

Unverified Answer

What does bi 425809 usually treat?

"The present study suggested that treatment of a clinical trial of BDNF in the prefrontal cortex, where the primary site of action is thought to be, was associated with improvements in a relatively wide range of symptom dimensions in patients with psychosis. ClinicalTrials.gov identifier: (NCT00391278)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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