Cognitive impairment associated with schizophrenia Schizophrenia
Conditions
Interventions
There are two treatment groups: 
- Iclepertin once daily
- Placebo once daily
The treatment period is 26 weeks.
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patient must be capable of providing a signed and dated written informed consent by visit 1 in accordance with International Council on Harmonisation for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. 2. Male or female patients who are 18-50 years (inclusive) of age at time of consent. 3. Diagnosis of schizophrenia utilizing DSM-5 with the following clinical features: -- Outpatient, clinically stable and in the residual (non-acute) phase of their illness. -- No hospitalization or increase in level of psychiatric care due to worsening of schizophrenia within 12 weeks prior to randomization. -- PANSS score: items P1, P3-P6 <= 5 and item P2 and P7 <= 4 at Visit 1, and confirmed at Visit 2. 4. Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties staying focused, difficulties remembering instructions, what to say or how to get to places, per investigator judgement. 5. Patients maintained on current antipsychotic treatment (minimum 1 and maximum 2 antipsychotics, but clozapine is not allowed) for at least 12 weeks and on current dose for at least 35 days prior to randomization. -- For patients on two antipsychotics, at least one antipsychotic must be within the approved label dose range. The second antipsychotic must not exceed the maximum daily dose per local label. Note: If the total dose is stable, different dosage forms of the same antipsychotic treatment will be considered as one antipsychotic. 6. 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. Maximum daily benzodiazepine load of up to 1 mg lorazepam-equivalent as needed (pro re nata, prn). Table of relevant medications and their equivalencies will be provided as a part of ISF -- For any other psychoactive medications cannot exceed the maximum daily dose per local label of the country where the study is being conducted. Further criteria apply.
Exclusion criteria
Exclusion criteria: 1. Participant with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar, schizoaffective, major depressive disorder etc. M.I.N.I. for Psychotic disorders should be used for guidance. 2. Cognitive impairment due to developmental, neurological (e.g., stroke) or other disorders including head trauma, or patients with dementia or epilepsy. 3. Severe movement disorders -- Leading to cognitive impairment (e.g. Parkinson dementia), or -- Interfering with the efficacy assessments, or -- Due to antipsychotic treatment that cannot be controlled with low dose anticholinergic treatment (equal to maximum 1 mg benztropine twice daily). Table of relevant medications and their equivalencies will be provided as a part of ISF 4. Any suicidal behavior in the past 1-year prior to screening and during the screening period. 5. Suicidal ideation of type 5 in the C-SSRS (ie. active suicidal thought with plan and intent) in the past 3 months prior to screening and up to and including Visit 2. -- Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan), within 3 months prior to screening and up to and including visit 2, can be randomized in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide. 6. History of moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 within the last 12 months prior to informed consent. 7. Positive urine drug screen at Visit 1 based on central lab test. For a list of drugs assessed in the urine drug screen, please refer to Table 5.2.3:1. 8. Patients who were treated with any of the following within 6 months prior to randomization: -- Clozapine -- Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil) -- Ketamine or esketamine -- Electroconvulsive therapy (ECT) or modified ECT Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint include: - Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary efficacy endpoints include: - Change from baseline in the SCoRS interviewer total score after 26 weeks of treatment. - Change from baseline to Week 26 in the adjusted total time T-score in the VRFCAT The secondary efficacy endpoints include: - Change from baseline to week 26 in the T-score of number of correct responses on Tower of London (ToL). - Change in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score from screening visit 1a to Week 24 | — |
Countries
Netherlands
Outcome results
None listed