SchizophreniaPhase 3NCT00237939
A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices
A Phase 3 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 20 sites in 5 countries.
Trial summary
The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole
- How many people
- 1,200 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Sep 2002to Nov 2006
- 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
- Clinical DSM-IV diagnosis of schizophrenia
- Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required
Who cannot join
- Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes
- Prisoners or subjects compulsory detained
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Belgium9 sites
Local Institution
Antwerp
Local Institution
Brussels
Local Institution
Diest
Local Institution
Kortenberg
Local Institution
Liège
Local Institution
Sint-Michiels
Local Institution
Sint-Niklaas
Local Institution
Sint-Truiden
Local Institution
Tournai
Portugal4 sites
Local Institution
Barcelos
Local Institution
Ceira
Local Institution
Coimbra
Local Institution
Lisbon
Netherlands3 sites
Local Institution
Amersfoort
Local Institution
Raalte
Local Institution
Rotterdam
Spain3 sites
Local Institution
Barcelona
Local Institution
Salamanca
Local Institution
Seville
About this study
Official title: A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA)
The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-Improvement at endpoint
Secondary outcomes (1)
Patients' and caregivers' medication preference
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startSep 2002
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The 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
- None (open label)
- Enrolment
- 1,200 participants
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Investigators
- Hervé Allain, MD, Principal investigator, Faculté de Médecine de Rennes I, laboratoire de pharmacologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237939
- Sponsor's protocol ID
- CN138-100
- Status last verified
- Oct 2007
- First submitted
- 11 Oct 2005
- Last updated
- 8 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA)
- ClinicalTrials.gov ID
- NCT00237939
- Acronym / sponsor ID
- CN138-100
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Sep 2002
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 13 Oct 2005 (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 purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical DSM-IV diagnosis of schizophrenia
- Patients being managed as outpatients, for whom an alteration in medication is clinically reasonable or initiation of antipsychotics is required
Key exclusion criteria (2 listed)
- Risk of committing suicide, diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic syptoms, or organic brain syndromes
- Prisoners or subjects compulsory detained
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 |
|---|---|---|
| Aripiprazole | Drug | – |
Primary outcome
Clinical Global Impression-Improvement at endpoint
1 secondary outcome
Patients' and caregivers' medication preference
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
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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.
Hervé Allain, MD principal investigator
Faculté de Médecine de Rennes I, laboratoire de pharmacologie
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 20 sites in 5 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Belgium, Portugal, Netherlands, Spain, France. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Global Impression-Improvement at endpoint. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2013.