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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.
ClinicalTrials.gov 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

October 9, 2008
October 10, 2008
November 8, 2016
September 2008
October 2009   (Final data collection date for primary outcome measure)
Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12 [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00770744 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Efficacy of Lu 31-130 in Patients With Schizophrenia
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
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Drug: Zicronapine
    5-7mg/day; orally, encapsulated tablets, once daily
    Other Name: Lu 31-130
  • Drug: Olanzapine
    10-15mg/day; orally, encapsulated tablets, once daily
    Other Name: Zyprexa
  • Experimental: Zicronapine
    Intervention: Drug: Zicronapine
  • Active Comparator: Olanzapine
    Intervention: Drug: Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Hong Kong,   Indonesia,   Philippines,   Poland,   Spain,   Thailand
2008-000479-11 ( EudraCT Number )
Not Provided
Not Provided
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP