Status:

TERMINATED

Efficacy of Bifeprunox in Patients With Schizophrenia

Lead Sponsor:

H. Lundbeck A/S

Conditions:

Schizophrenia

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.

Detailed Description

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. There are a number of antipsychotic drugs in use but none is ideal, in particular beca...

Eligibility Criteria

Inclusion

  • Main inclusion criteria
  • The subject has a primary diagnosis of schizophrenia
  • The subject experiences clinically significant symptoms
  • The subject's medication remained stable for 8 weeks prior to screening
  • The subject is currently in the post-acute maintenance phase of his/her disease

Exclusion

  • Main exclusion criteria
  • The subject is at significant risk of suicide
  • The subject is treatment resistant
  • The subject has experienced an acute exacerbation within 8 weeks prior screening
  • The subject is unlikely to comply with the protocol
  • The subject has a current diagnosis or a history of substance abuse

Key Trial Info

Start Date :

June 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2009

Estimated Enrollment :

346 Patients enrolled

Trial Details

Trial ID

NCT00704509

Start Date

June 1 2008

End Date

November 1 2009

Last Update

September 27 2010

Active Locations (45)

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Page 1 of 12 (45 locations)

1

IN008

Ahmedabad, India, 380006

2

IN011

Ahmedabad, India, 380013

3

IN009

Aurangabad, India, 431005

4

IN003

Bangalore, India, 560002