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Completed

NCT Number: NCT00770744

Efficacy of 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CZ005, Litoměřice, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zicronapine

Drug

5-7mg/day; orally, encapsulated tablets, once daily

Other names: Lu 31-130

Olanzapine

Drug

10-15mg/day; orally, encapsulated tablets, once daily

Other names: Zyprexa

Primary outcomes

  1. Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 10, 2008
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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