Efficacy of Bifeprunox in Patients With Schizophrenia

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Terminated

CT.gov ID

NCT00704509

Collaborator

(none)

346

Enrollment

Locations

Arms

Duration (Months)

7.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Bifeprunox Drug: Placebo Drug: Quetiapine	Phase 3

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

346 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bifeprunox	Drug: Bifeprunox 20 mg daily, encapsulated tablets, orally, 12 months Other Names: 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 Names: Seroquel

Arm

Intervention/Treatment

Experimental: Bifeprunox

Drug: Bifeprunox

20 mg daily, encapsulated tablets, orally, 12 months

Other Names:

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 Names:

Seroquel

Outcome Measures

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). [12 weeks]

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. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	IN008	Ahmedabad	India	380006
2	IN011	Ahmedabad	India	380013
3	IN009	Aurangabad	India	431005
4	IN003	Bangalore	India	560002
5	IN006	Chennai	India	600003
6	IN007	Kanpur	India	208005
7	IN002	Lucknow	India	226003
8	IN001	Mangalore	India	575018
9	IN010	Varanasi	India	221005
10	IN005	Visakhapatnam	India	530017
11	ID002	Bangli	Indonesia	80613
12	ID001	Jakarta	Indonesia	10430
13	ID003	Kabupaten Bandung	Indonesia	40551
14	KR004	Busan	Korea, Republic of	614-735
15	KR008	Gyeongnam	Korea, Republic of	626-770
16	KR005	Pusan	Korea, Republic of	602-739
17	KR006	Seoul	Korea, Republic of	143-711
18	KR001	Seoul	Korea, Republic of	150-713
19	KR007	South Korea	Korea, Republic of	200-704
20	MY005	Johor Bahru	Malaysia	Johor
21	MY001	Kuala Lumpur	Malaysia	50603
22	MY004	Kuala Lumpur	Malaysia	55100
23	MY003	Perak	Malaysia	31250
24	PH004	Cebu City	Philippines	6000
25	PH001	Mandaluyong City	Philippines	1553
26	PH002	Manila	Philippines	1000
27	PH003	Pasig City	Philippines	1607
28	PH005	Quezon City	Philippines	0870
29	PL005	Choroszcz	Poland	16-070
30	PL007	Kutno	Poland
31	PL002	Leszno	Poland	64-100
32	PL004	Lodz	Poland	91-229
33	PL003	Lublin	Poland	20-109
34	PL008	Skorzewo	Poland	60-185
35	PL006	Swicie n/Wisla	Poland	86-100
36	PL001	Torun	Poland	87-100
37	UA008	Dnipropetrovsk	Ukraine	49005
38	UA009	Donetsk	Ukraine	83037
39	UA006	Kharkiv	Ukraine	61068
40	UA003	Kyiv	Ukraine	04080
41	UA004	Lviv	Ukraine	79021
42	UA011	Odessa	Ukraine	65006
43	UA005	Poltava	Ukraine	36024
44	UA007	Stepanovka, Kherson	Ukraine	73488
45	UA010	Vinnitsa	Ukraine	21018