Lu AE58054 is under development by H.Lundbeck A/S as an anti-psychotic in the treatment of schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia MedDRA version: 9.1 Level: PT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Product Name: Lu AE58054
Product Code: Lu AE58054
Pharmaceutical Form: Capsule*
Current Sponsor code: Lu AE58054
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient, who meets all the following criteria, both at the Screening Visit and at the Baseline Visit, is eligible for inclusion in this study: 1. The patient and if applicable, his/her legal representative and/or impartial witness (if wished for by the patient) is/are able to read and understand the Patient Information Sheet 2. The patient and if applicable, his/her legal representative has/have signed the Informed Consent Form and the impartial witness (if wished for by the patient) has co-signed the Informed Consent Form and this was done prior to the conduct of any study related procedures 3. The patient has a primary diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR; codes 295.10, 295.20, 295.30, 295.60, 295.90) 4. The patient is a man or woman, aged between 18 and 65 years (extremes included) 5. The patient is able to communicate with study personnel 6. On the basis of physical and neurological examination, medical history, ECG, blood biochemistry, haematology tests, and a urinalysis carried out at screening, the patient is, in the investigator’s opinion, otherwise healthy 7. The patient has been on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening and during the 2-week run-in period prior to baseline 8. The patient has a PANSS total score between 70 and 100 (extremes included) at screening and has had an improvement of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The patient has a current Axis I primary psychiatric diagnosis other than schizophrenia according to the DSM-IV-TR criteria 2. The patient is in an emergency situation for urgent relief of symptoms 3. The patient has had an acute exacerbation requiring hospitalisation within the last 6 weeks prior to screening 4. The patient is at significant risk of suicide and/or violent behaviour, as judged by the investigator 5. The patient has a diagnosis of mental retardation (according to the DSM-IV-TR criteria) or history of pervasive developmental disorder 6. The patient has other psychiatric, neurological or behavioural disorders that may interfere with the conduct or interpretation of the study 7. The patient is treatment resistant to antipsychotic treatment, as judged by the investigator. 8. The patient has a history of moderate or severe head trauma 9. The patient has a history of seizures, with the exception of childhood seizures 10. The patient has physical, cognitive or language impairment of such severity as to adversely affect the validity of data 11. The patient has any malignant disease or a history of malignant neoplasm, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the past 5 years prior to screening 12. The patient has had neuroleptic malignant syndrome 13. The patient has clinically significant extrapyramidal symptoms (SAS score >6) 14. The patient has positive serology for HIV based on blood samples drawn at screening 15. The patient has clinically significant unstable physical illness: cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, haematological, autoimmune, infectious, metabolic disturbance, liver, or renal disease, as judged by the investigator. Adequately treated hypertension and diabetes are not considered an exclusion criterion 16. The patient has a history of clinically significant cardiovascular disease, myocardial infarction, ischemic heart disease, congestive heart failure, cardiac hypertrophy, conduction disorder, arrhythmia, or bradycardia (<50 beats per minute), as judged by the investigator 17. The patient has congenital long QT syndrome or a family history of this disease, or known acquired QT interval prolongation (QTc above 450 msec in men and 470 msec in women at screening) 18. The patient has clinically significant abnormal vital signs, as judged by the investigator 19. The patient has clinically significant ECG abnormalities at screening, as judged by the investigator 20. The patient has clinically significant abnormal laboratory data at screening, or any abnormal laboratory value that could interfere with the assessment of safety, as judged by the investigator 21. The patient has a current diagnosis of substance abuse or history of substance (except for cannabinoid, nicotine, and caffeine) or alcohol abuse (according to the DSM-IV-TR criteria) within the 6 months prior to screening 22. The patient has a current diagnosis of cannabis dependence according to DSM-IV-TR criteria 23. The patient has a positive urine drug screen (except for cannabinoids) obtained at screening 24. The patient is taking medications known to potently inhibit or induce the hepatic cytochrome P450 CYP 2D6 and other CYP isozymes. 25. The patient has received a depot antipsychotic medication within less than one dose interval prior to screening 26. The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to or has other contra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of a fixed dose of Lu AE58054 (120 mg/day) as augmentation therapy to risperidone (4 to 8 mg/day), compared to risperidone with placebo, after 12 weeks of treatment, by measuring the change in the Positive and Negative Syndrome Scale (PANSS) total score in patients with schizophrenia;Secondary Objective: To also explore the effect, after 12 weeks of treatment on: -- neurocognitive performance using the Brief Assessment of Cognition in Schizophrenia (BACS) battery - depressive symptoms using the Calgary Depression Scale for Schizophrenia (CDSS) - quality of life using the Schizophrenia Quality of Life (S-QoL) scale - treatment response using the Clinical Global Impression – Severity of Illness (CGI-S) and the Clinical Global Impression – Global Improvement (CGI-I) scales - body weight, body mass index (BMI), waist circumference and laboratory parameters including fasting serum lipids, blood glucose and HbA1c - To determine the population pharmacokinetics of Lu AE58054 and risperidone in patients with schizophrenia and relate it to relevant pharmacodynamic parameters - To explore the associations between biomarkers (that is, genetic variants) and clinical features such as disease symptoms, drug response, or adverse events. ;Primary end point(s): Change from baseline in PANSS total score | — |
Countries
Belgium, France, Germany, Italy, Poland
Outcome results
None listed