Efficacy of Bifeprunox in Patients With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00704509
• Other study ID #: 11916A
• Secondary ID: 2007-001098-27
• Status: Terminated
• Phase: Phase 3
• First received: June 24, 2008
• Last updated: September 24, 2010
• Start date: June 2008
• Est. completion date: November 2009

Study information

• Verified date: September 2010
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndonesia: National Agency of Drug and Food ControlMalaysia: Ministry of HealthPhilippines: Bureau of Food and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSouth Korea: Korea Food and Drug Administration (KFDA)Ukraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 346
• Est. completion date: November 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Bifeprunox
20 mg daily, encapsulated tablets, orally, 12 months
• Placebo
Encapsulated tablets, orally, 12 weeks
• Quetiapine
600 mg daily, encapsulated tablets, orally, 12 months

Locations

Country	Name	City	State
India	IN008	Ahmedabad
India	IN011	Ahmedabad
India	IN009	Aurangabad
India	IN003	Bangalore
India	IN006	Chennai
India	IN007	Kanpur
India	IN002	Lucknow
India	IN001	Mangalore
India	IN010	Varanasi
India	IN005	Visakhapatnam
Indonesia	ID002	Bangli
Indonesia	ID001	Jakarta
Indonesia	ID003	Kabupaten Bandung
Korea, Republic of	KR004	Busan
Korea, Republic of	KR008	Gyeongnam
Korea, Republic of	KR005	Pusan
Korea, Republic of	KR001	Seoul
Korea, Republic of	KR006	Seoul
Korea, Republic of	KR007	South Korea
Malaysia	MY005	Johor Bahru
Malaysia	MY001	Kuala Lumpur
Malaysia	MY004	Kuala Lumpur
Malaysia	MY003	Perak
Philippines	PH004	Cebu City
Philippines	PH001	Mandaluyong City
Philippines	PH002	Manila
Philippines	PH003	Pasig City
Philippines	PH005	Quezon City
Poland	PL005	Choroszcz
Poland	PL007	Kutno
Poland	PL002	Leszno
Poland	PL004	Lodz
Poland	PL003	Lublin
Poland	PL008	Skorzewo
Poland	PL006	Swicie n/Wisla
Poland	PL001	Torun
Ukraine	UA008	Dnipropetrovsk
Ukraine	UA009	Donetsk
Ukraine	UA006	Kharkiv
Ukraine	UA003	Kyiv
Ukraine	UA004	Lviv
Ukraine	UA011	Odessa
Ukraine	UA005	Poltava
Ukraine	UA007	Stepanovka, Kherson
Ukraine	UA010	Vinnitsa

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

India,  Indonesia,  Korea, Republic of,  Malaysia,  Philippines,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).		12 weeks	No
Secondary	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.		12 months	No