Clinical trial NCT00810667: Efficacy Study Exploring the Effect of Lu AE58054 as Augmentation Therapy in Patients With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Cognition
Keywords: Schizophrenia
Cognition
BACS
Risperidone
Augmentation therapy
Add-on therapy
Lu AE58054
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy effect of treatment based on the PANSS total score
timeFrame: 12 weeks
Secondary outcomes:
measure: PANSS subscales scores, CGI-S and CGI-I scores, CDSS scores, S-QoL scores, BACS, Abnormal movement scales (AIMS, BARS, SAS), ECGs, serum prolactin, pharmacokinetic assessments
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: BE001
city: Liege
country: Belgium
facility: BE005
city: Bordeaux
country: France
facility: FR002
city: Brumath
country: France
facility: FR003
city: Nimes
country: France
facility: FR001
city: Toulouse
country: France
facility: FR006
city: Dresden
country: Germany
facility: DE002
city: Hong Kong
country: Hong Kong
facility: HK001
city: Brescia
country: Italy
facility: IT003
city: Napoli
country: Italy
facility: IT004
city: Belchatow
country: Poland
facility: PL009
city: Bialystok
country: Poland
facility: PL006
city: Leszno
country: Poland
facility: PL002
city: Lodz
country: Poland
facility: PL012
city: Lublin
country: Poland
facility: PL003
city: Lublin
country: Poland
facility: PL001
city: Piekary Slaskie
country: Poland
facility: PL010
city: Skorzewo
country: Poland
facility: PL004
city: Torun
country: Poland
facility: PL008
city: Warszawa
country: Poland
facility: PL011
city: Wrzesnia
country: Poland
facility: PL007
city: Hualien
country: Taiwan
facility: TW001
city: Keelung
country: Taiwan
facility: TW003
city: Tainan
country: Taiwan
facility: TW004
city: Chiang Mai
country: Thailand
facility: TH002
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: