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Efficacy of Bifeprunox in Patients With Schizophrenia

NCT ID: NCT00704509

Last Updated: 2010-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bifeprunox

Group Type EXPERIMENTAL

Bifeprunox

Intervention Type DRUG

20 mg daily, encapsulated tablets, orally, 12 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Encapsulated tablets, orally, 12 weeks

Quetiapine

Group Type ACTIVE_COMPARATOR

Quetiapine

Intervention Type DRUG

600 mg daily, encapsulated tablets, orally, 12 months

Interventions

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Bifeprunox

20 mg daily, encapsulated tablets, orally, 12 months

Intervention Type DRUG

Placebo

Encapsulated tablets, orally, 12 weeks

Intervention Type DRUG

Quetiapine

600 mg daily, encapsulated tablets, orally, 12 months

Intervention Type DRUG

Other Intervention Names

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DU 127090 Seroquel

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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H. Lundbeck A/S

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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IN008

Ahmedabad, , India

Site Status

IN011

Ahmedabad, , India

Site Status

IN009

Aurangabad, , India

Site Status

IN003

Bangalore, , India

Site Status

IN006

Chennai, , India

Site Status

IN007

Kanpur, , India

Site Status

IN002

Lucknow, , India

Site Status

IN001

Mangalore, , India

Site Status

IN010

Varanasi, , India

Site Status

IN005

Visakhapatnam, , India

Site Status

ID002

Bangli, , Indonesia

Site Status

ID001

Jakarta, , Indonesia

Site Status

ID003

Kabupaten Bandung, , Indonesia

Site Status

MY005

Johor Bahru, , Malaysia

Site Status

MY001

Kuala Lumpur, , Malaysia

Site Status

MY004

Kuala Lumpur, , Malaysia

Site Status

MY003

Perak, , Malaysia

Site Status

PH004

Cebu City, , Philippines

Site Status

PH001

Mandaluyong, , Philippines

Site Status

PH002

Manila, , Philippines

Site Status

PH003

Pasig, , Philippines

Site Status

PH005

Quezon City, , Philippines

Site Status

PL005

Choroszcz, , Poland

Site Status

PL007

Kutno, , Poland

Site Status

PL002

Leszno, , Poland

Site Status

PL004

Lodz, , Poland

Site Status

PL003

Lublin, , Poland

Site Status

PL008

Skorzewo, , Poland

Site Status

PL006

Swicie n/Wisla, , Poland

Site Status

PL001

Torun, , Poland

Site Status

KR004

Busan, , South Korea

Site Status

KR008

Gyeongnam, , South Korea

Site Status

KR005

Pusan, , South Korea

Site Status

KR006

Seoul, , South Korea

Site Status

KR001

Seoul, , South Korea

Site Status

KR007

South Korea, , South Korea

Site Status

UA008

Dnipropetrovsk, , Ukraine

Site Status

UA009

Donetsk, , Ukraine

Site Status

UA006

Kharkiv, , Ukraine

Site Status

UA003

Kyiv, , Ukraine

Site Status

UA004

Lviv, , Ukraine

Site Status

UA011

Odesa, , Ukraine

Site Status

UA005

Poltava, , Ukraine

Site Status

UA007

Stepanovka, Kherson, , Ukraine

Site Status

UA010

Vinnitsa, , Ukraine

Site Status

Countries

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India Indonesia Malaysia Philippines Poland South Korea Ukraine

References

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Ceraso A, Lin JJ, Schneider-Thoma J, Siafis S, Tardy M, Komossa K, Heres S, Kissling W, Davis JM, Leucht S. Maintenance treatment with antipsychotic drugs for schizophrenia. Cochrane Database Syst Rev. 2020 Aug 11;8(8):CD008016. doi: 10.1002/14651858.CD008016.pub3.

Reference Type DERIVED
PMID: 32840872 (View on PubMed)

Other Identifiers

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2007-001098-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11916A

Identifier Type: -

Identifier Source: org_study_id