SchizophreniaPhase 3NCT00704509
Efficacy of Bifeprunox in Patients With Schizophrenia
A Phase 3 study testing Bifeprunox and Quetiapine in people with Schizophrenia, run by H. Lundbeck A/S at 45 sites in 7 countries.
Trial summary
The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Bifeprunox and Quetiapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 45 sitesin 7 countries
- Study dates
- Jun 2008to Nov 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
45 sites in 7 countries.
45 sites in 7 countries
India10 sites
IN008
Ahmedabad, 380006
IN011
Ahmedabad, 380013
IN003
Bangalore, 560002
IN006
Chennai, 600003
IN009
Chhatrapati Sambhajinagar, 431005
IN007
Kanpur, 208005
IN002
Lucknow, 226003
IN001
Mangalore, 575018
IN010
Varanasi, 221005
IN005
Visakhapatnam, 530017
Ukraine9 sites
UA008
Dnipropetrovsk, 49005
UA009
Donetsk, 83037
UA006
Kharkiv, 61068
UA003
Kyiv, 04080
UA004
Lviv, 79021
UA011
Odesa, 65006
UA005
Poltava, 36024
UA007
Stepanovka, Kherson, 73488
UA010
Vinnitsa, 21018
Poland8 sites
PL005
Choroszcz, 16-070
PL007
Kutno
PL002
Leszno, 64-100
PL004
Lodz, 91-229
PL003
Lublin, 20-109
PL008
Skorzewo, 60-185
PL006
Swicie n/Wisla, 86-100
PL001
Torun, 87-100
South Korea6 sites
KR004
Busan, 614-735
KR008
Gyeongnam, 626-770
KR005
Pusan, 602-739
KR006
Seoul, 143-711
KR001
Seoul, 150-713
KR007
South Korea, 200-704
Philippines5 sites
PH004
Cebu City, 6000
PH001
Mandaluyong, 1553
PH002
Manila, 1000
PH003
Pasig, 1607
PH005
Quezon City, 0870
Malaysia4 sites
MY005
Johor Bahru, Johor
MY001
Kuala Lumpur, 50603
MY004
Kuala Lumpur, 55100
MY003
Perak, 31250
Indonesia3 sites
ID002
Bangli, 80613
ID001
Jakarta, 10430
ID003
Kabupaten Bandung, 40551
About this study
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
The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.
Read the 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).
- Conditions
- Schizophrenia
- Being tested
- Bifeprunox, Placebo, Quetiapine
- Keywords
- Schizophrenia, Antipsychotic, Bifeprunox
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BifeprunoxDrug
Also called DU 127090
20 mg daily, encapsulated tablets, orally, 12 months
PlaceboDrug
Encapsulated tablets, orally, 12 weeks
QuetiapineDrug
Also called Seroquel
600 mg daily, encapsulated tablets, orally, 12 months
| Study group | Role | What they receive |
|---|---|---|
| Bifeprunox | Experimental | Not described Receives: Drug: Bifeprunox |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Quetiapine | Active comparator | Not described Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS).
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionNov 2009
Why it stopped: Interim analysis showed inadequate efficacy of bifeprunox
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704509
- Sponsor's protocol ID
- 11916A
- Other IDs
- 2007-001098-27
- Status last verified
- Sep 2010
- First submitted
- 24 Jun 2008
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32840872
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00704509
- Acronym / sponsor ID
- 11916A
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Antipsychotic, Bifeprunox
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed inadequate efficacy of bifeprunox
- Enrolment
- 346 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bifeprunox | Experimental | Drug: Bifeprunox |
| Placebo | Placebo comparator | Drug: Placebo |
| Quetiapine | Active comparator | Drug: Quetiapine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BifeprunoxAlso: DU 12709020 mg daily, encapsulated tablets, orally, 12 months | Drug | Bifeprunox |
| PlaceboEncapsulated tablets, orally, 12 weeks | Drug | Placebo |
| QuetiapineAlso: Seroquel600 mg daily, encapsulated tablets, orally, 12 months | Drug | Quetiapine |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Interim analysis showed inadequate efficacy of bifeprunox). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2010.
- Derived from this study: PubMed 32840872Ceraso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
45 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bifeprunox and Quetiapine in people with Schizophrenia, run by H. Lundbeck A/S at 45 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in India, Ukraine, Poland, South Korea, Philippines and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis showed inadequate efficacy of bifeprunox). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00704509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2010.