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

NCT ID: NCT00810667

Last Updated: 2016-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-02-28

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.

Conditions

Schizophrenia; Cognition

Keywords

Schizophrenia; Cognition; BACS; Risperidone; Augmentation therapy; Add-on therapy; Lu AE58054

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lu AE58054

Group Type: EXPERIMENTAL

Lu AE58054

Intervention Type: DRUG

twice daily oral dose (60 mg BID: total dose 120 mg/day)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

twice daily oral dose

Interventions

Lu AE58054

twice daily oral dose (60 mg BID: total dose 120 mg/day)

Intervention Type: DRUG

Placebo

twice daily oral dose

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

BE001

Liège, , Belgium

BE005

Liège, , Belgium

FR002

Bordeaux, , France

FR003

Brumath, , France

FR001

Nîmes, , France

FR006

Toulouse, , France

DE002

Dresden, , Germany

HK001

Hong Kong, , Hong Kong

IT003

Brescia, , Italy

IT004

Napoli, , Italy

PL009

Bełchatów, , Poland

PL006

Bialystok, , Poland

PL002

Leszno, , Poland

PL012

Lodz, , Poland

PL003

Lublin, , Poland

PL001

Lublin, , Poland

PL010

Piekary Śląskie, , Poland

PL004

Skorzewo, , Poland

PL008

Torun, , Poland

PL011

Warsaw, , Poland

PL007

Września, , Poland

TW001

Hualien City, , Taiwan

TW003

Keelung, , Taiwan

TW004

Tainan City, , Taiwan

TH002

Chiang Mai, , Thailand

Countries

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

Study Documents

Document Type: EMA EudraCT Results

View Document

Other Identifiers

2008-001441-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12450A

Identifier Type: -

Identifier Source: org_study_id