A randomised, double-blind, parallel-group, fixed dose study exploring the efficacy and safety of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia. - N/A

• Conditions: u AE58054 is under development by H.Lundbeck A/S and is currently being investigated for treatment of conditions of cognitive impairment associated with schizophrenia.; MedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia; MedDRA version: 9.1Level: PTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2008-001441-26-PL
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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 <20% in the PANSS total score at baseline
9.The patient has a CGI-S score of ³4 (moderately ill) at screening and baseline
10.The patient has a score of £4 (moderate) on the following PANSS items at screening and baseline:
-P2 (conceptual disorganisation)
-P7 (hostility)
-G8 (uncooperativeness)
11.The patient, if female, 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 had her last natural menstruation at least 24 months prior to baseline, OR
-have been surgically sterilised prior to baseline, OR
-have had a hysterectomy prior to baseline, OR
-not be 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

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

Study & Design

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