Study Details

Open

This study tests whether BI 425809 improves mental functioning in patients with schizophrenia.

This study tests whether the investigational study medicine BI 425809 improves mental functioning in patients with schizophrenia.

Age & Gender

18 years ~ 50 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will meet with a member of the study team to complete interviews and questionnaires. The study will also involve vital signs, blood draws, EKGs, and collecting urine samples. Participants must be willing to take the provided study medication everyday for the duration of the study.

Incentives

Information provided upon request. Payments will be received via a Visa gift card., gas reimbursement

In-person visits:
13-14

Total length of participation:
26 weeks

Looking for Specific Volunteers

Able to participate:

Have a diagnosis of schizophrenia
Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomization
Be on stable antipsychotic treatment, up to 2 antipsychotics, except for clozapine
Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties to stay focused, difficulties to remember instructions
Must have a study partner, you interact with at least 2 times a week (in-person or telephone)

Not eligible if:

Diseases of the central nervous system (CNS)
Any suicidal behavior in the past 1-year prior to screening and during the screening period
You have participated in a clinical trial with repeated assessments with the MATRICS Consensus Cognitive Battery in the last 3 months
Cognitive Remediation Therapy (CRT) within 12 weeks prior to screening
Previous participation in any BI 425809 study

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

North Carolina Psychiatric Research Center (NCPRC)
Center for Excellence in Community Mental Health
3010 Falstaff Rd, Raleigh, NC 27610, USA

Secondary Visit Location

Medical School Wing B (UNC-Chapel Hill)
332 Emergency Room Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Fred Jarskog
Psychiatry - General

Study Type

Clinical or Medical
Interventional

Study Topics

Chronic Conditions
Mental and Emotional Health

IRB Number

22-1827

ClinicalTrials.gov

NCT04860830