Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

• Status: Recruiting
• Trial end date: 2024-05-03
• Target enrollment: 0
• Participant gender: All

Summary

This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called BI 425809 improves learning and memory in people with schizophrenia.

Participants are put into two groups randomly, which means by chance. One group takes BI 425809 tablets and the other group takes placebo tablets. Placebo tablets look like BI 425809 tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.

During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.

Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: BI 425809

Criteria

Inclusion criteria

• Signed and dated written informed consent.

• Male or female patients who are 18-50 years (inclusive) of age at time of consent.

• Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).

-- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.

• Patients should have functional impairment in day-to-day activities per investigator judgement.

• Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.

• Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.

• Women of childbearing potential must use highly effective methods of birth control.

• Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.

Exclusion criteria

• Patient with current DSM-5 diagnosis other than Schizophrenia.

• Cognitive impairment due to other causes, or patients with dementia.

• Severe movement disorders.

• Any suicidal behavior in past year or suicidal ideation in the past 3 months.

• History of moderate or severe substance use disorder within the last 12 months prior to informed consent.

• Positive urine drug screen.

• Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.

• Current participation in any investigational drug trial.

• Cognitive Remediation Therapy within 12 weeks prior to screening.

• Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.

• Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.

• Haemoglobin (Hb) below lower limit of normal .

• History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.

• Severe renal impairment.

• Indication of liver disease.

• Any documented active or suspected malignancy or history of malignancy within 5 years.

• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.

Further exclusion criteria apply.