Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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 or epilepsy.
- 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.