This study tests whether BI 425809 together with brain training using a computer improves mental functioning in patients withschizophrenia

Phase 1

• Conditions: schizophrenia; MedDRA version: 20.0Level: LLTClassification code 10039632Term: Schizophrenia NOSSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-002740-82-GB
• Lead Sponsor: Boehringer Ingelheim Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-29
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Male or female patients who are 18-50 years (inclusive) of age at time of consent
2. Established schizophrenia DSM-5 with the following clinical features:
-Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomization
-Psychiatrically stable without symptom exacerbation within 3 months prior to randomization
-PANSS score = 5 on positive items P1, P3-P7 and = 4 on positive item P2 at Visit 1, and confirmed at Visit 2
3. Patients must be on stable antipsychotic treatment; also, current antipsychotic medications and concomitant anticholinergics, antiepileptics, lithium and allowed antidepressants must meet the criteria below:
-Patients must take 1 and may take up to 2 antipsychotics (typical and/or atypical), except for clozapine
-Patients must be stable on current antipsychotics, anticholinergics, antiepileptics, lithium and allowed antidepressants for at least 3 months prior to randomization and be on current dose for at least 30 days prior to randomization
--Patients on long-acting injectable (LAI) antipsychotics should be on the same medication and dose for at least 3 months prior to randomization
4. Patients must demonstrate their ability to properly use the CCT device and program, as well as be compliant with CCT run-in
5. Patients must have a study partner who will preferably be consistent throughout the study
Further criteria apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who have a categorical diagnosis of another current major psychiatric disorder on the M.I.N.I.
2. Patients with a history of participating in any formal cognitive remediation program for 10 or more training sessions
3. Patients who were treated with any of the following medications within the last 6 months prior to randomization:
-Bitopertin, BI 409306, encenicline or other investigational drug testing effects on cognition in schizophrenia
-Clozapine (atypical antipsychotic medication)
-Sarcosine, cycloserine, serine and glycine
-Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
-Tricyclic antidepressants
4. Patients who have participated in a clinical trial with repeated assessments (i.e. a single assessment is not exclusionary) with the MCCB within the last 6 months prior to randomization
5. Significant history of drug abuse disorder within the last 6 months prior to informed consent, or a positive urine drug screen at Visit 1
6. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Further criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified