Efficacy Study Exploring the Effect of Lu AE58054 as Augmentation Therapy in Patients With Schizophrenia

Lundbeck

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Cognition

Treatments

Drug: Placebo

Drug: Lu AE58054

Study type

Interventional

Funder types

Industry

Identifiers

NCT00810667

2008-001441-26 (EudraCT Number)

12450A

Details and patient eligibility

About

The objective of this study is to explore the efficacy, safety and cognitive properties of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia.

Full description

Lu AE58054 is a selective 5-HT6 antagonist that is currently being investigated for treatment of conditions of cognitive impairment associated with schizophrenia. Substantial experimental evidence suggests that selective 5-HT6 receptor antagonists may be effective in treating cognitive deficits since they have been shown to improve performance in various animal models of cognitive function and are known to enhance cholinergic and glutaminergic neuronal function.

Lu AE58054 has been investigated in healthy volunteers and patients with schizophrenia, is generally well tolerated and has a benign side-effect profile. Moreover, no safety concerns or issues have been identified to date.

The study is designed to provide data on the efficacy, safety and cognitive properties of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia. Efficacy will be assessed in patients who are in a stable phase of their illness, but with a predefined minimum and maximum level of symptoms that will allow them to be included in the study. Patients will be randomly assigned to receive either the investigational medicinal product (IMP) or placebo as add-on therapy to their existing risperidone treatment.

Enrollment

124 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary diagnosis of schizophrenia
Man or woman, aged between 18-65
Patient is 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
The patient has a PANSS total score between 70 and 100 (extremes included) at screening

Exclusion criteria

Primary psychiatric diagnosis other than schizophrenia
Acute exacerbation requiring hospitalisation within the last 3 months
Clinically significant extrapyramidal symptoms
Clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia
Significant ECG abnormalities
In concurrent treatment with drugs inhibiting the P450 enzymes system CYP2D6 and other CYP Isozymes
Failed to respond to adequate courses of treatment with risperidone
Treated with an antipsychotic other than risperidone within 4 weeks prior to screening