Efficacy of Lu 31-130 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: NCT00770744
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Zicronapine Drug: Olanzapine Phase 2

Detailed Description:

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. However, none of the available drugs is ideal, in particular because of their complex safety profile and the limited effectiveness against certain symptom domains. Whereas positive symptoms respond to treatment the effects on negative symptoms and cognitive impairment are only very modest.

Thus present treatment options leave room for improvement and call for new, more effective pharmacotherapies for the treatment of schizophrenia. In the current study, patients suffering from schizophrenia and experiencing clinically significant symptoms of the disease will be included. Eligible patients will be randomised to blinded treatment with either flexible doses of Lu 31-130 or flexible doses of a standard antipsychotic treatment (olanzapine) for 12 weeks. The efficacy (including potential effects on cognitive symptoms) and the safety of Lu 31-130 will be explored in comparison to olanzapine.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Exploring the Efficacy and Safety of 12 Weeks Treatment With Lu 31-130 in Patients With Schizophrenia
Study Start Date : September 2008
Primary Completion Date : October 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Zicronapine Drug: Zicronapine
5-7mg/day; orally, encapsulated tablets, once daily
Other Name: Lu 31-130
Active Comparator: Olanzapine Drug: Olanzapine
10-15mg/day; orally, encapsulated tablets, once daily
Other Name: Zyprexa

Primary Outcome Measures :
  1. Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in cognitive symptoms using Assessment of Cognition in Schizophrenia (BACS) test battery. Change in Clinical Global Impression/Improvement (CGI-S/I) scores. Change in Calgary Depression Scale for Schizophrenia (CDSS) score. Safety 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)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The subject has a primary diagnosis of schizophrenia
  • The subject experiences clinically significant symptoms
  • The subject is willing to be hospitalized during the initial period of the study
  • The subject has normal serum values of parameters associated with liver function

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): NCT00770744

Czech Republic
Ceske Budejovice, Czech Republic, 37087
Litomerice, Czech Republic, 41201
Lnare, Czech Republic, 38742
Olomouc, Czech Republic, 77111
Olomouc, Czech Republic, 77520
Praha 8, Czech Republic, 18100
Clermont-Ferrand, Cedex 1, France, 63003
Dole, France, 39100
Jonzac, France, 17503
Hong Kong
Hong Kong, Hong Kong
Bangli, Indonesia, 80613
Jakarta, Indonesia, 10430
Baguio, Philippines, 2600
Mandaluyong City, Philippines, 1553
Gdansk, Poland, 80-211
Lodz, Poland, 92-216
Barcelona, Spain, 8025
Salamanca, Spain, 37003
Zamora, Spain, 49021
Bangkok, Thailand, 10330
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: 2008-000479-11

Responsible Party: H. Lundbeck A/S Identifier: NCT00770744     History of Changes
Other Study ID Numbers: 12396A
2008-000479-11 ( EudraCT Number )
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by H. Lundbeck A/S:
Lu 31-130

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents