A phase II randomised, double-blinded, placebo-controlled study toevaluate the efficacy, safety, and tolerability of four orally administrateddoses of BI 409306 during a 12-week treatment period in patients withschizophrenia on stable antipsychotic treatment

Boehringer Ingelheim Pharma GmbH & Co. KG0 sites722 target enrollmentAugust 4, 2014

ConditionsPatients with schizophrenia on stable antispychotic treatment MedDRA version: 18.1Level: 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: 722
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 4, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Boehringer Ingelheim Pharma GmbH & Co. KG

Eligibility Criteria

Inclusion Criteria

•Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM\-5\)) with the following clinical features:
•a) Clinically stable and are in the residual (non\-acute) phase of their illness for at least 8 weeks
•b) Current antipsychotic and concomitant psychotropic medications must meet the criteria below:
•b)\-1 Maintained on current atypical (second generation) antipsychotic medications (in any approved dosage form) other than Clozapine and on current dose for at least 8 weeks prior to randomisation, and/or
•b)\-2 Maintained on current typical (first generation) antipsychotic medications and on current dose for at least 6 months, optionally combined with anticholinergics if treated with a stable dose for at least 6 months prior to randomisation, and/or
•b)\-3 Maintained on current concomitant psychotropic medications other than anticholinergics, antiepileptics and lithium, and on current dose for at least 8 weeks prior to randomisation. Antiepileptics and lithium are allowed if initiated at least 6 months prior to randomisation.
•b)\-4 Anticholinergics, antiepileptics and lithium have been washed out
•for at least 6 months prior to randomisation if the treatments that
•patients were using before entering the clinical trial are discontinued.
•c) Have no more than a ‘‘moderate’’ severity rating on hallucinations and delusions (Positive and Negative Syndrome Scale (PANSS)–positive syndrome Hallucinatory Behavior item score \= 4 and Delusions item score \= 4\)

Exclusion Criteria

•1\) Patient treated with more than two antipsychotic medications (including more than two dosage forms)
•2\) Patient’s cognitive impairment severity compromises the validity of the cognitive outcome measures, in the clinical judgment of the investigator
•3\) Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior)
•4\) Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C\-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
•5\) In the judgment of the investigator, any clinically significant finding of the medical examination (including BP, PR and ECG) or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient’s safety while participating in the clinical trial
•6\) History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hematological or hormonal disorders
•7\) For female patients:
•Pre\-menopausal women (last menstruation \=1 year prior to informed consent) who:
•\- are nursing or pregnant or
•\- are of child\-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial until 28 days after the last treatment administration, and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, vasectomized partner, transdermal patch, intra uterine devices/systems (IUDs/IUSs), combined estrogen\-progestin oral contraceptives as well as implantable or injectable hormonal contraceptives. Complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptom\-thermal, post\-ovulation methods) and withdrawal are not acceptable methods of contraception. Double barrier methods are permissible (if acceptable by local health authorities, note that this is not an acceptable method in EU countries).