Lu 31-130 is under development by H. Lundbeck A/S as an antipsychotic in the treatment of schizophrenia MedDRA version: 9.1 Level: PT Classification code 10039639 Term: Schizophrenia, paranoid type MedDRA version: 9.1 Level: PT Classification code 10039637 Term: Schizophrenia, catatonic type MedDRA version: 9.1 Level: PT Classification code 10039638 Term: Schizophrenia, disorganised type MedDRA version: 9.1 Level: PT Classification code 10052792 Term: Schizophrenia, undifferentiated type
Conditions
Interventions
Product Name: Lu 31-130
Product Code: Lu 31-130
Pharmaceutical Form: Capsule*
Current Sponsor code: Lu 31-130
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Tr
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient and/or legally acceptable 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/or legally accepted representative and/or impartial witness (if wished for by the patient) has/have read the Patient Information Sheet 3. The patient and/or legally accepted representative has/have signed the Informed Consent Form and impartial witness (if wished for by the patient) has co-signed the Informed Consent Form (if relevant) and this was done prior to the conduct of any study related procedures 4. The patient has a primary diagnosis of schizophrenia according to DSM-IV TR (codes 295.10, 295.20, 295.30, 295.90) 5. The patient is a man or woman, aged between 18 and 65 years (extremes included) 6. The patient is able to communicate with study personnel 7. The patient has a PANSS total score between 70 and 120 (extremes included) at Screening 2 and Baseline 8. The patient has a CGI-S score equal or more than 4 (moderately ill) at Screening 1, Screening 2 and Baseline 9. The patient is willing to be hospitalised during the period from Screening 2 until vist 5 at least 10. The patient, if a woman, must: - agree not to try to become pregnant during the study, AND - use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), OR - have been surgically sterilised prior to Baseline, OR - have had a hysterectomy prior to Baseline, OR - not have been sexually active 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 F.1.3 Elderly (>=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 except for nicotine- or caffeine-related disorder (DSM-IV TR criteria) 2 The patient is at significant risk of suicide 3 The patient has shown violent behaviour within 12 months prior to Screening1 4 The patient is treatment-resistent to antipsychotic treatment 5 The patient has been treated with clozapine within 60 days prior to Screening1 6 The patient has other psychiatric, neurological (including tardive dyskinesia), or behavioural disorders that may interfere with the study results 7 The patient has a history of alcohol- or substance-related disorder (except nicotine, caffeine) based on DSM-IV-TR criteria within six months prior to Screening 1 8 The patient has a positive drug screen at Screening1, with the exception that positive result for opioids, cannabinoids, and benzodiazepines will be evaluated by Investigator on the impact for study participation 9 The patient has abnormal (above the upper limit of normal range) liver biochemistry values (that is, ASAT, ALAT, AP, and total bilirubin) based on the blood samples drawn at Screening1. 10 The patient has positive serology for Hepatitis A (anti HAV IgM), Hepatitis B (HbsAg), Hepatitis C (HCV), or HIV based on blood samples drawn at Screening 1 11 The patient has a present condition that might compromise the liver function (for example alcohol abuse, hepatitis, hepatic insufficiency, cholestasis, haemochromatosis, deficit in alpha 1 antitrypsine, Wilson Disease, autoimmune diseases, cirrhosis) 12 The patient has one or more laboratory values outside the normal reference range, that are considered by investigator to be clinically significant 13 The patient is diagnosed with diabetes mellitus 14 The patient has a history of moderate or severe head trauma or other neurological disorders and systemic medical diseases, which are likely to affect the central nervous system functioning 15 The patient has a history of neuroleptic malignant syndrome 16 The patient has an uncorrected hypothyroridism or hyperthyroidism 17 The patient has a history of severe drug allergy or hypersensitivity, to or has other contraindications to serotonergic agents, dopamine antagonists, or dopamine agonists 18 The patient uses disallowed medication, or it is expected that the patient will require treatment with at least one of the disallowed concomittant medications during the study 19 The patient has a clinically significant unstable illness 20 The patient has a malignant disease or a history of malignant disease, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the past five years prior to Screening1 21 The patient has clinically significant abnormal vital signs 22 The patient has uncontrolled or symptomatic hypotension, or orthostatic hypotension 23 The patient has a history of repeated vasovagal syncope 24 The patient has an abnormal ECG recorded at Screening1 that is considered to be clinically significant 25 The patient has a QTc interval on the ECG recorded at Screening1 above 450 msec when using the Fridericia correction or a family history of Long QT Syndrome or a history of hypokalaemia or has known heart failure (NYHA II-IV) or if the patient takes medication that prolongs the QTc interval 26 The patient has a known ischaemic heart disease or a history of myocardial infarction (within the previous 12 months), coronary artery bypass surgery or percutaneo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: None;Primary end point(s): NA;Main Objective: to explore efficacy of Lu 31-130 (5 or 7mg/day) compared to olanzapine (10 or 15mg/day) following 12 weeks of treatment by means of change in PANSS total score in patients with schizophrenia to explore effect of Lu 31-130 (5 or 7mg/day) on neurocognitive performance compared to olanzapine (10 or 15mg/day) using the Brief Assessment of Cognition in Schizophrenia battery to explore effect of Lu 31-130 (5 or 7mg/day) on depressive symptoms compared to olanzapine (10 or 15 mg/day) using Calgary Depression Scale for Schizophrenia to explore effect of Lu 31-130 (5 or 7mg/day) on body weight compared to olanzapine (10 or 15mg/day) to explore effect of Lu 31-130 (5 or 7mg/day) on body mass index, waist circumference, total cholesterol, LDL-cholesterol, VLDL-cholesterol, HDL-cholesterol, triglycerides, HbA1c and fasting glucose compared to olanzapine (10 or 15mg/day) to explore effect of Lu 31-130 (5 or 7mg/day) on serum levels of ALAT and ASAT compared to olanzapine (10 or 15mg/day) | — |
Countries
Czech Republic, France, Spain
Outcome results
None listed