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Efficacy of Bifeprunox in Patients With Schizophrenia

NCT ID: NCT00658645

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

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

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 (11916A).

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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BG002

Radnevo, , Bulgaria

Site Status

BG003

Radnevo, , Bulgaria

Site Status

CN009

Beijing, , China

Site Status

CN008

Beijing, , China

Site Status

GR001

Marousi, , Greece

Site Status

GR003

Tripoli, , Greece

Site Status

RO004

Brasov, , Romania

Site Status

RO001

Bucharest, , Romania

Site Status

RO002

Bucharest, , Romania

Site Status

RO003

Bucharest, , Romania

Site Status

RO009

Bucharest, , Romania

Site Status

RO008

Iași, , Romania

Site Status

RO005

Piteşti, , Romania

Site Status

RO007

Sibiu, , Romania

Site Status

RO006

Târgovişte, , Romania

Site Status

RU003

Arkhangelsk, , Russia

Site Status

RU017

Chita, , Russia

Site Status

RU001

Moscow, , Russia

Site Status

RU005

Moscow, , Russia

Site Status

RU009

Saint Petersburg, , Russia

Site Status

RU013

Saint Petersburg, , Russia

Site Status

RU012

Saint Petersburg, , Russia

Site Status

RU011

Saint Petersburg, , Russia

Site Status

RU004

Saint Petersburg, , Russia

Site Status

RU010

Saint Petersburg, , Russia

Site Status

RU014

Saint Petersburg, , Russia

Site Status

RU002

Saratov, , Russia

Site Status

RU015

Tomsk, , Russia

Site Status

TW001

Hualien Town, , Taiwan

Site Status

TW003

Taipei, , Taiwan

Site Status

TH002

Bangkok, , Thailand

Site Status

TH001

Bangkok, , Thailand

Site Status

TH003

Chiang Mai, , Thailand

Site Status

TH004

Chiang Mai, , Thailand

Site Status

UA002

Hlevakha, , Ukraine

Site Status

UA001

Kyiv, , Ukraine

Site Status

UA013

Kyiv, , Ukraine

Site Status

UA012

Luhansk, , Ukraine

Site Status

Countries

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Bulgaria China Greece Romania Russia Taiwan Thailand 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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2007-001097-90

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11915A

Identifier Type: -

Identifier Source: org_study_id