Clinical trial of BI 425809 effect on cognition and functional capacity in schizophrenia.

JRCT ID: jRCT2031210251

Registered date:18/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: schizophrenia
• Date of first enrollment: 16/08/2021
• Target sample size: 586
• Countries of recruitment: Brazil,Japan,China,Japan,Colombia,Japan,Germany,Japan,Greece,Japan,Italy,Japan,Mexico,Japan,Norway,Japan,Poland,Japan,Russian Federation,Japan,Sweden,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Investigational Medical Product: BI 425809 or Placebo

Outcome(s)

• Primary Outcome: 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 Outcome

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 in the VRFCAT
Change from baseline to week 26 in the T-score of number of correct responses on Tower of London.
Change in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score from screening visit 1a to Week 24

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Both

Include criteria

Male or female patients who are 20-50 years (inclusive) of age at time of consent.
Diagnosis of schizophrenia utilizing Diagnostic and statistical manual of mental disorders, fifth edition (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.
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.
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.
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.
Have a study partner, defined as any person who knows the patient well, who has been capable of interacting with the patient on a regular basis, preferably consistent throughout the study, either private or professional.

Exclude criteria

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.
Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia.
Any suicidal behavior in the past 1-year prior to screening and during the screening period.
Suicidal ideation of type 5 in the C-SSRS 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.
Haemoglobin (Hb) below lower limit of normal at Visit 1 assessed by the central lab.

Related Information

• Primary Sponsor: Kenmochi Hiroki
• Secondary ID(s): NCT04846868