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

A phase III randomized, double-blind, placebo-controlled, parallel group trial to examine the efficacy and safety of BI 425809 once daily over 26 week treatment period in patients with schizophrenia (CONNEX-2)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210241

Enrollment

586

Registered

2021-08-13

Start date

2021-08-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment Associated with Schizophrenia

Interventions

Patients randomised to BI 425809 10 mg should take 1 tablet of BI 425809 10 mg once daily orally after waking up. Patients randomised to Placebo should take 1 tablet of Placebo once daily orally after

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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, fifth edition (DSM-5) with the following clinical features: - Outpatient, clinically stable and in the residual (nonacute) phase of their illness. - No hospitalization1 or increase in level of psychiatric care2 due to worsening of schizophrenia within 12 weeks prior to randomization. - PANSS score: items P1, P3-P6 are 5 or lower and item P2 and P7 are 4 or lower 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. etc

Exclusion criteria

Exclusion criteria: Patient 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. etc

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Argentina, Brazil, Chile, Croatia, France, Hungary, Japan, Netherlands, Poland, Romania, Serbia, Slovakia, South Korea, Spain, Ukraine, United States

Contacts

Public ContactShizuko Kawahara

Boehringer Ingelheim

medchiken.jp@boehringer-ingelheim.com+81-120-189-779

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026