Efficacy of Bifeprunox in Patients With Schizophrenia

This study has been terminated.
(Interim analysis showed inadequate efficacy of bifeprunox)
Sponsor:
Information provided by:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00704509
First received: June 24, 2008
Last updated: September 24, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Bifeprunox
Drug: Placebo
Drug: Quetiapine
Phase 3

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 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 346
Study Start Date: June 2008
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bifeprunox Drug: Bifeprunox
20 mg daily, encapsulated tablets, orally, 12 months
Other Name: DU 127090
Placebo Comparator: Placebo Drug: Placebo
Encapsulated tablets, orally, 12 weeks
Active Comparator: Quetiapine Drug: Quetiapine
600 mg daily, encapsulated tablets, orally, 12 months
Other Name: Seroquel

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 (11915A).

  Eligibility

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

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
  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: NCT00704509

  Hide Study Locations
Locations
India
IN008
Ahmedabad, India, 380006
IN011
Ahmedabad, India, 380013
IN009
Aurangabad, India, 431005
IN003
Bangalore, India, 560002
IN006
Chennai, India, 600003
IN007
Kanpur, India, 208005
IN002
Lucknow, India, 226003
IN001
Mangalore, India, 575018
IN010
Varanasi, India, 221005
IN005
Visakhapatnam, India, 530017
Indonesia
ID002
Bangli, Indonesia, 80613
ID001
Jakarta, Indonesia, 10430
ID003
Kabupaten Bandung, Indonesia, 40551
Korea, Republic of
KR004
Busan, Korea, Republic of, 614-735
KR008
Gyeongnam, Korea, Republic of, 626-770
KR005
Pusan, Korea, Republic of, 602-739
KR006
Seoul, Korea, Republic of, 143-711
KR001
Seoul, Korea, Republic of, 150-713
KR007
South Korea, Korea, Republic of, 200-704
Malaysia
MY005
Johor Bahru, Malaysia, Johor
MY001
Kuala Lumpur, Malaysia, 50603
MY004
Kuala Lumpur, Malaysia, 55100
MY003
Perak, Malaysia, 31250
Philippines
PH004
Cebu City, Philippines, 6000
PH001
Mandaluyong City, Philippines, 1553
PH002
Manila, Philippines, 1000
PH003
Pasig City, Philippines, 1607
PH005
Quezon City, Philippines, 0870
Poland
PL005
Choroszcz, Poland, 16-070
PL007
Kutno, Poland
PL002
Leszno, Poland, 64-100
PL004
Lodz, Poland, 91-229
PL003
Lublin, Poland, 20-109
PL008
Skorzewo, Poland, 60-185
PL006
Swicie n/Wisla, Poland, 86-100
PL001
Torun, Poland, 87-100
Ukraine
UA008
Dnipropetrovsk, Ukraine, 49005
UA009
Donetsk, Ukraine, 83037
UA006
Kharkiv, Ukraine, 61068
UA003
Kyiv, Ukraine, 04080
UA004
Lviv, Ukraine, 79021
UA011
Odessa, Ukraine, 65006
UA005
Poltava, Ukraine, 36024
UA007
Stepanovka, Kherson, Ukraine, 73488
UA010
Vinnitsa, Ukraine, 21018
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: NCT00704509     History of Changes
Other Study ID Numbers: 11916A, 2007-001098-27
Study First Received: June 24, 2008
Last Updated: September 24, 2010
Health Authority: India: Drugs Controller General of India
Indonesia: National Agency of Drug and Food Control
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Korea: Korea Food and Drug Administration (KFDA)
Ukraine: Ministry of Health

Keywords provided by H. Lundbeck A/S:
Schizophrenia
Antipsychotic
Bifeprunox

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 21, 2014