Clinical trial of BI 425809 effect on cognition and functional capacity in schizophrenia CONNEX-1
Summary
The purpose of this trial is to confirm the efficacy, safety and tolerability of a new investigational drug (trial medication), BI 425809 in
improving cognition and functioning in patients with schizophrenia
Some examples of cognitive skills are as follows
Learning and/or memory:
Remembering where you put something
Remembering what you were asked to buy at a store
Remembering a phone number just given to you
Remembering where you put something in the closet
Attention:
Being able to follow a conversation
Being able to read a book or pay attention to a movie
Problem solving:
Arriving on time when your bus schedule has changed
Speed of processing:
Using a touch-screen computer to serve customers at a fast-food restaurant
Making the correct change when using cash to pay for something
BI 425809 may help improve cognitive functioning because it increases the activity of certain neurotransmitters (chemical messengers that send signals from one brain cell to another) that are important for your brain to work well.
Eligibility
Eligible gender: Male, Female
Eligible ages: 18 to 50
Inclusion criteria:
Male and female out-patients age 18-50.
Diagnosis of schizophrenia
On stable antipsychotic therapy
Patients to have a consistent study partner that will support them throughout the study.
In good physical health
Exclusion criteria:
Pt. with diagnosis other than Schizophrenia, including but not limited to bipolar,
schizoaffective, major depressive disorder etc.
Cognitive impairment due to developmental, neurological (e.g.,
epilepsy, stroke) or other disorders including head trauma, or patients with dementia.
Any suicidal behavior in the past 1-year prior to screening and
during the screening period.
Suicidal ideation in the past 3 months
prior to screening and up to and including Visit 2.
Haemoglobin (Hb) below lower limit of normal at Visit 1
assessed by the central lab.
Participate
Additional information
Contact information
Mental Health Clinical Trials Unit University of Calgary Mathison Centre for Mental Health Research & Education TRW Building, 1st floor 403-210-6904 natasha.wen@ucalgary.ca
Principal investigator:
Thomas Raedler
Clinical trial:
Yes
REB-ID:
REB22-0898