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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810667
• Other study ID #: 12450A
• Secondary ID: 2008-001441-26
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2008
• Last updated: November 7, 2016
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: November 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hong Kong: Department of HealthItaly: The Italian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsTaiwan: Department of HealthThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition
• Schizophrenia

Intervention

Drug:
• Lu AE58054
twice daily oral dose (60 mg BID: total dose 120 mg/day)
• Placebo
twice daily oral dose

Locations

Country	Name	City	State
Belgium	BE001	Liege
Belgium	BE005	Liege
France	FR002	Bordeaux
France	FR003	Brumath
France	FR001	Nimes
France	FR006	Toulouse
Germany	DE002	Dresden
Hong Kong	HK001	Hong Kong
Italy	IT003	Brescia
Italy	IT004	Napoli
Poland	PL009	Belchatow
Poland	PL006	Bialystok
Poland	PL002	Leszno
Poland	PL012	Lodz
Poland	PL001	Lublin
Poland	PL003	Lublin
Poland	PL010	Piekary Slaskie
Poland	PL004	Skorzewo
Poland	PL008	Torun
Poland	PL011	Warszawa
Poland	PL007	Wrzesnia
Taiwan	TW001	Hualien
Taiwan	TW003	Keelung
Taiwan	TW004	Tainan
Thailand	TH002	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hong Kong,  Italy,  Poland,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy effect of treatment based on the PANSS total score		12 weeks	No
Secondary	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		12 weeks	Yes