Efficacy of Lu 31-130 in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00770744
First received: October 9, 2008
Last updated: July 1, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Zicronapine
Drug: Olanzapine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Change in the Positive and Negative Syndrome Scale (PANSS) score from Baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: September 2008
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770744

Locations
Czech Republic
CZ001
Ceske Budejovice, Czech Republic, 37087
CZ005
Litomerice, Czech Republic, 41201
CZ004
Lnare, Czech Republic, 38742
CZ002
Olomouc, Czech Republic, 77111
CZ003
Olomouc, Czech Republic, 77520
CZ006
Praha 8, Czech Republic, 18100
France
FR001
Clermont-Ferrand, Cedex 1, France, 63003
FR002
Dole, France, 39100
FR003
Jonzac, France, 17503
Hong Kong
HK001
Hong Kong, Hong Kong
Indonesia
ID001
Bangli, Indonesia, 80613
ID002
Jakarta, Indonesia, 10430
Philippines
PH002
Baguio, Philippines, 2600
PH001
Mandaluyong City, Philippines, 1553
Poland
PL003
Gdansk, Poland, 80-211
PL002
Lodz, Poland, 92-216
Spain
ES001
Barcelona, Spain, 8025
ES002
Salamanca, Spain, 37003
ES004
Zamora, Spain, 49021
Thailand
TH001
Bangkok, Thailand, 10330
TH002
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00770744     History of Changes
Other Study ID Numbers: 12396A, 2008-000479-11
Study First Received: October 9, 2008
Last Updated: July 1, 2010
Health Authority: Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on September 22, 2014