Efficacy of Lu 31-130 in Patients With Schizophrenia

NCT ID: NCT00770744

Last Updated: 2016-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-11-30

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.

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Antipsychotic; Olanzapine; Lu 31-130

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zicronapine

Group Type: EXPERIMENTAL

Zicronapine

Intervention Type: DRUG

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

Olanzapine

Group Type: ACTIVE_COMPARATOR

Olanzapine

Intervention Type: DRUG

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

Interventions

Zicronapine

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

Intervention Type: DRUG

Olanzapine

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

Intervention Type: DRUG

Other Intervention Names

Lu 31-130; Zyprexa

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

CZ001

České Budějovice, , Czechia

CZ005

Litoměřice, , Czechia

CZ004

Lnáře, , Czechia

CZ002

Olomouc, , Czechia

CZ003

Olomouc, , Czechia

CZ006

Prague, , Czechia

FR001

Clermont-Ferrand, , France

FR002

Dole, , France

FR003

Jonzac, , France

HK001

Hong Kong, , Hong Kong

ID001

Bangli, , Indonesia

ID002

Jakarta, , Indonesia

PH002

Baguio City, , Philippines

PH001

Mandaluyong, , Philippines

PL003

Gdansk, , Poland

PL002

Lodz, , Poland

ES001

Barcelona, , Spain

ES002

Salamanca, , Spain

ES004

Zamora, , Spain

TH001

Bangkok, , Thailand

TH002

Chiang Mai, , Thailand

Countries

Czechia; France; Hong Kong; Indonesia; Philippines; Poland; Spain; Thailand

Study Documents

Document Type: EMA EudraCT Results

View Document

Other Identifiers

2008-000479-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12396A

Identifier Type: -

Identifier Source: org_study_id