Efficacy of Lu 31-130 in Patients With Schizophrenia

November 7, 2016 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

93

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ceske Budejovice, Czech Republic, 37087
        • CZ001
      • Litomerice, Czech Republic, 41201
        • CZ005
      • Lnare, Czech Republic, 38742
        • CZ004
      • Olomouc, Czech Republic, 77111
        • CZ002
      • Olomouc, Czech Republic, 77520
        • CZ003
      • Praha 8, Czech Republic, 18100
        • CZ006
  • France
      • Clermont-Ferrand, Cedex 1, France, 63003
        • FR001
      • Dole, France, 39100
        • FR002
      • Jonzac, France, 17503
        • FR003
  • Hong Kong
      • Hong Kong, Hong Kong
        • HK001
  • Indonesia
      • Bangli, Indonesia, 80613
        • ID001
      • Jakarta, Indonesia, 10430
        • ID002
  • Philippines
      • Baguio, Philippines, 2600
        • PH002
      • Mandaluyong City, Philippines, 1553
        • PH001
  • Poland
      • Gdansk, Poland, 80-211
        • PL003
      • Lodz, Poland, 92-216
        • PL002
  • Spain
      • Barcelona, Spain, 8025
        • ES001
      • Salamanca, Spain, 37003
        • ES002
      • Zamora, Spain, 49021
        • ES004
  • Thailand
      • Bangkok, Thailand, 10330
        • TH001
      • Chiang Mai, Thailand, 50200
        • TH002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (Estimate)

October 10, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12396A
  • 2008-000479-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. EMA EudraCT Results
    Information identifier: 2008-000479-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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