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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Cognition
• Intervention / Treatment: Drug: Lu AE58054; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • BE001
  • Liege, Belgium, 4000
    • BE005
• France
  • Bordeaux, France, 33076
    • FR002
  • Brumath, France, 67170
    • FR003
  • Nimes, France, 30029
    • FR001
  • Toulouse, France, 31059
    • FR006
• Germany
  • Dresden, Germany, 1307
    • DE002
• Hong Kong
  • Hong Kong, Hong Kong
    • HK001
• Italy
  • Brescia, Italy
    • IT003
  • Napoli, Italy
    • IT004
• Poland
  • Belchatow, Poland, 97-400
    • PL009
  • Bialystok, Poland, 15 617
    • PL006
  • Leszno, Poland, 64 100
    • PL002
  • Lodz, Poland, 91-229
    • PL012
  • Lublin, Poland, 20 080
    • PL003
  • Lublin, Poland, 20 442
    • PL001
  • Piekary Slaskie, Poland, 41-940
    • PL010
  • Skorzewo, Poland, 60 185
    • PL004
  • Torun, Poland, 87-100
    • PL008
  • Warszawa, Poland, 02-791
    • PL011
  • Wrzesnia, Poland, 62 300
    • PL007
• Taiwan
  • Hualien, Taiwan, 98142
    • TW001
  • Keelung, Taiwan, 204
    • TW003
  • Tainan, Taiwan, 704
    • TW004
• Thailand
  • Chiang Mai, Thailand, 50200
    • TH002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; twice daily oral dose
EXPERIMENTAL: Lu AE58054	Drug: Lu AE58054; twice daily oral dose (60 mg BID: total dose 120 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy effect of treatment based on the PANSS total score	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: December 17, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (ESTIMATE): December 18, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 7, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Schizophrenia; Risperidone; Cognition; BACS; Lu AE58054; Augmentation therapy; Add-on therapy
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 12450A; 2008-001441-26 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Study Data/Documents

1. EMA EudraCT Results
   Information identifier: 2008-001441-26