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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810667
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
H. Lundbeck A/S

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Cognition Drug: Lu AE58054 Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Efficacy effect of treatment based on the PANSS total score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810667

Liege, Belgium, 4000
Liege, Belgium, 4000
Bordeaux, France, 33076
Brumath, France, 67170
Nimes, France, 30029
Toulouse, France, 31059
Dresden, Germany, 1307
Hong Kong
Hong Kong, Hong Kong
Brescia, Italy
Napoli, Italy
Belchatow, Poland, 97-400
Bialystok, Poland, 15 617
Leszno, Poland, 64 100
Lodz, Poland, 91-229
Lublin, Poland, 20 080
Lublin, Poland, 20 442
Piekary Slaskie, Poland, 41-940
Skorzewo, Poland, 60 185
Torun, Poland, 87-100
Warszawa, Poland, 02-791
Wrzesnia, Poland, 62 300
Hualien, Taiwan, 98142
Keelung, Taiwan, 204
Tainan, Taiwan, 704
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S

Study Data/Documents: EMA EudraCT Results  This link exits the site
Identifier: 2008-001441-26

Responsible Party: H. Lundbeck A/S Identifier: NCT00810667     History of Changes
Other Study ID Numbers: 12450A
2008-001441-26 ( EudraCT Number )
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

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

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents