NCT00770744

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
8 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

October 9, 2008

Last Update Submit

November 7, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaAntipsychoticOlanzapineLu 31-130

Outcome Measures

Primary Outcomes (1)

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

    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.

    12 weeks

Study Arms (2)

Zicronapine

EXPERIMENTAL
Drug: Zicronapine

Olanzapine

ACTIVE COMPARATOR
Drug: Olanzapine

Interventions

ZicronapineDRUG

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

Also known as: Lu 31-130
Zicronapine
OlanzapineDRUG

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

Also known as: Zyprexa
Olanzapine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

CZ001

České Budějovice, 37087, Czechia

Location

CZ005

Litoměřice, 41201, Czechia

Location

CZ004

Lnáře, 38742, Czechia

Location

CZ002

Olomouc, 77111, Czechia

Location

CZ003

Olomouc, 77520, Czechia

Location

CZ006

Prague, 18100, Czechia

Location

FR001

Clermont-Ferrand, 63003, France

Location

FR002

Dole, 39100, France

Location

FR003

Jonzac, 17503, France

Location

HK001

Hong Kong, Hong Kong

Location

ID001

Bangli, 80613, Indonesia

Location

ID002

Jakarta, 10430, Indonesia

Location

PH002

Baguio City, 2600, Philippines

Location

PH001

Mandaluyong, 1553, Philippines

Location

PL003

Gdansk, 80-211, Poland

Location

PL002

Lodz, 92-216, Poland

Location

ES001

Barcelona, 8025, Spain

Location

ES002

Salamanca, 37003, Spain

Location

ES004

Zamora, 49021, Spain

Location

TH001

Bangkok, 10330, Thailand

Location

TH002

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

FR(3)HK(1)ID(2)TH(2)PL(2)CZ(6)PH(2)ES(3)