ProScience Research Group | Culver City, CA
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About
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 iclepertin improves learning and memory in people with schizophrenia.
Participants are put into two groups randomly, which means by chance. One group takes iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like iclepertin 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 and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
Enrollment
Sex
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Inclusion and exclusion 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
Further exclusion criteria apply.
Primary purpose
Allocation
Interventional model
Masking
609 participants in 2 patient groups, including a placebo group
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Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
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