Efficacy of Bifeprunox in Patients With Schizophrenia

September 24, 2010 updated by: H. Lundbeck A/S

A Multinational, Randomised, Double-blind, Fixed-dose, Bifeprunox Study Combining a 12-Week Placebo-controlled, Quetiapine-referenced Phase With a 12-month Quetiapine-controlled Phase in Patients With Schizophrenia

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 because their safety profile is complex and their effectiveness is limited. In particular, after having overcome acute exacerbations many patients continue to experience significant symptoms that prevent an adequate functioning. In the current study, patients suffering from schizophrenia and currently in a post-acute maintenance phase of the disease will be included. Non-treatment resistant patients will be included in the study, since they have partially responded to their current antipsychotic treatment but still have clinically significant symptoms and/or impairment of functioning in their daily life. The study is a 12-month study with an initial 12-week placebo-controlled, quetiapine-referenced phase. After this initial 12-week phase, the patients allocated to placebo will be switched to bifeprunox. In the final non-inferiority analysis of the 12-month data, the results from this study will be combined with the data from a similar study (11916A).

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Radnevo, Bulgaria, 6260
        • BG002
      • Radnevo, Bulgaria, 6260
        • BG003
  • China
      • Beijing, China, 100083
        • CN009
      • Beijing, China, 100088
        • CN008
  • Greece
      • Maroussi, Greece, 15126
        • GR001
      • Tripoli, Greece, 22100
        • GR003
  • Romania
      • Brasov, Romania, 500123
        • RO004
      • Bucuresti, Romania, 041914
        • RO001
      • Bucuresti, Romania, 041914
        • RO002
      • Bucuresti, Romania, 041914
        • RO003
      • Bucuresti, Romania, 41914
        • RO009
      • Iasi, Romania, 700265
        • RO008
      • Pitesti, Romania, 110069
        • RO005
      • Sibiu, Romania, 550082
        • RO007
      • Targoviste, Romania, 130081
        • RO006
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163060
        • RU003
      • Chita, Russian Federation, 672090
        • RU017
      • Moscow, Russian Federation, 115522
        • RU001
      • Moscow, Russian Federation, 117152
        • RU005
      • Saratov, Russian Federation, 410012
        • RU002
      • St. Petersburg, Russian Federation, 190005
        • RU009
      • St. Petersburg, Russian Federation, 190005
        • RU013
      • St. Petersburg, Russian Federation, 190013
        • RU012
      • St. Petersburg, Russian Federation, 191119
        • RU011
      • St. Petersburg, Russian Federation, 193019
        • RU004
      • St. Petersburg, Russian Federation, 193019
        • RU010
      • St. Petersburg, Russian Federation, 193167
        • RU014
      • Tomsk, Russian Federation, 634014
        • RU015
  • Taiwan
      • Hualien Town, Taiwan, 970
        • TW001
      • Taipei, Taiwan, 115
        • TW003
  • Thailand
      • Bangkok, Thailand, 10330
        • TH002
      • Bangkok, Thailand, 10600
        • TH001
      • Chiang Mai, Thailand, 50200
        • TH003
      • Chiang Mai, Thailand, 50200
        • TH004
  • Ukraine
      • Glevakha, Ukraine, 8630
        • UA002
      • Kyiv, Ukraine, 02660
        • UA001
      • Kyiv, Ukraine, 4655
        • UA013
      • Lugansk, Ukraine, 91045
        • UA012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Encapsulated tablets, orally, 12 weeks
Experimental: Bifeprunox
Drug: Bifeprunox
20 mg daily, encapsulated tablets, orally, 12 months
Other Names:
  • DU 127090
Active Comparator: Quetiapine
Drug: Quetiapine
600 mg daily, encapsulated tablets, orally, 12 months
Other Names:
  • Seroquel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The difference in PANSS score at the 12-month time point between bifeprunox and quetiapine. Also, responder rate, time to response/withdrawal, global clinical assessments (CGI), assessment of depressive symptoms (CDSS) and health economic assessments
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 9, 2008

First Submitted That Met QC Criteria

April 9, 2008

First Posted (Estimate)

April 15, 2008

Study Record Updates

Last Update Posted (Estimate)

September 27, 2010

Last Update Submitted That Met QC Criteria

September 24, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11915A
  • 2007-001097-90 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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