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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00810667
First received: December 17, 2008
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Cognition
Drug: Lu AE58054
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Efficacy effect of treatment based on the PANSS total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 124
Study Start Date: November 2008
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AE58054 Drug: Lu AE58054
twice daily oral dose (60 mg BID: total dose 120 mg/day)
Placebo Comparator: Placebo Drug: Placebo
twice daily oral dose

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810667

Locations
Belgium
BE005
Liege, Belgium, 4000
BE001
Liege, Belgium, 4000
France
FR002
Bordeaux, France, 33076
FR003
Brumath, France, 67170
FR001
Nimes, France, 30029
FR006
Toulouse, France, 31059
Germany
DE002
Dresden, Germany, 1307
Hong Kong
HK001
Hong Kong, Hong Kong
Italy
IT003
Brescia, Italy
IT004
Napoli, Italy
Poland
PL009
Belchatow, Poland, 97-400
PL006
Bialystok, Poland, 15 617
PL002
Leszno, Poland, 64 100
PL012
Lodz, Poland, 91-229
PL001
Lublin, Poland, 20 442
PL003
Lublin, Poland, 20 080
PL010
Piekary Slaskie, Poland, 41-940
PL004
Skorzewo, Poland, 60 185
PL008
Torun, Poland, 87-100
PL011
Warszawa, Poland, 02-791
PL007
Wrzesnia, Poland, 62 300
Taiwan
TW001
Hualien, Taiwan, 98142
TW003
Keelung, Taiwan, 204
TW004
Tainan, Taiwan, 704
Thailand
TH002
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00810667     History of Changes
Other Study ID Numbers: 12450A, 2008-001441-26
Study First Received: December 17, 2008
Last Updated: August 13, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hong Kong: Department of Health
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Taiwan: Department of Health
Thailand: Food and Drug Administration

Keywords provided by H. Lundbeck A/S:
Schizophrenia
Cognition
BACS
Risperidone
Augmentation therapy
Add-on therapy
Lu AE58054

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 16, 2014