A phase II randomised, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of 4 oral doses of BI 425809 once daily over12 week treatment period in patients with Schizophrenia

Boehringer Ingelheim Pharma GmbH & Co. KG0 sites720 target enrollmentApril 14, 2016

ConditionsPatients with schizophrenia on stable antispychotic treatment MedDRA version: 20.0Level: LLTClassification code 10039634Term: Schizophrenia residualSystem Organ Class: 100000004873 Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with schizophrenia on stable antispychotic treatment
Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG
Enrollment: 720
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 14, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Boehringer Ingelheim Pharma GmbH & Co. KG

Eligibility Criteria

Inclusion Criteria

•\- Men or women who are 18\-50 years (inclusive) of age at time of consent.
•\- Established schizophrenia with the following clinical features:
•a) Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomisation;
•b) Medically stable over the prior 4 weeks and psychiatrically stable without symptom exacerbation within 3 months prior to randomisation;
•c) patients who have no more than a moderate severe rating on the PANSS positive items P1, P3\-P7 and no more than a moderate rating on the PANSS positive item P2\.
•\- Current antipsychotic and concomitant psychotropic medications as assessed at Visit 1 must meet the criteria below:
•a) patients may have up to 2 antipsychotics (typical and/or atypical);
•b) patients must be maintained on current typical and/or atypical antipsychotics other than Clozapine and on current dose for at least 4 weeks prior to randomisation and/or maintained on current long acting injectable antipsychotics and current dose for at least 3 months prior to randomization;
•c) patients must be maintained on current concomitant psychotropic medications, anticholinergics, antiepilectics and/or lithium for at least 3 months prior to randomisation and on current dose for at least 4 weeks prior to randomisation.
•\- Women of child\-bearing potential must be ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly.

Exclusion Criteria

•\- Patients who have a categorical diagnosis of another current major psychiatric disorder.
•\- Diseases of the central nervous system that may impact cognitive test performance.
•\- Movement disorder not currently controlled.
•\- Patients receiving another investigational drug or procedure within 30 days or 6 half\-lives (whichever is longer) or recent participation in another trial with any cognitive enhancing therapy.
•\- Recent participation in formal cognitive remediation program.
•\- Recent electroconvulsive therapy.
•\- Patients who have been on BI 409306, encenicline or other investigational drug testing effects on cognition in schizophrenia within the last 6 months prior to randomisation or who have previously been on bitopertin.
•\- Participation in a clinical trial with repeated MATRICS Consensus Cognitive Battery (MCCB) assessments within the last 6 months.
•\- Patients who required change in their ongoing stable benzodiazepine or sleep medication regimen within the last 4 weeks prior to randomisation.
•\- Treatment with Clozapine within 6 months prior to randomisation.