SchizophreniaPhase 3NCT00237913
Schizophrenia Trial of Aripiprazole
A Phase 3 study testing Aripiprazole and Olanzapine or Quetiapine or Risperidone in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 33 sites in 9 countries.
Trial summary
Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone). 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 and Olanzapine or Quetiapine or Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 33 sitesin 9 countries
- Study dates
- Jul 2004to Aug 2005
- 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 diagnosis of schizophrenia
- Schizophrenia symptoms not optimally controlled or antipsychotic medication not well tolerated
Who cannot join
- Diagnosis of schizoaffective disorder
- Patients treatment-resistant to antipsychotics
Trial locations and contacts
33 sites in 9 countries.
33 sites in 9 countries
France10 sites
Local Institution
Brumath
Local Institution
Dole
Local Institution
Hénin-Beaumont
Local Institution
Jonzac
Local Institution
Nantes Orvault
Local Institution
Paris
Local Institution
Reims
Local Institution
Rennes
Local Institution
Toulouse
Local Institution
Uzès
United Kingdom7 sites
Local Institution
Belfast, Antrim
Local Institution
Birmingham, West Midlands
Local Institution
Davyhulme, Lancashire
Local Institution
Glasgow, Lanarkshire
Local Institution
London, Greater London
Local Institution
Royal Tunbridge Wells, Kent
Local Institution
South Wales, Mid Glamorgan
Germany5 sites
Local Institution
Duisburg
Local Institution
Hattingen
Local Institution
München
Local Institution
Nuremberg
Local Institution
Oldenburg
Sweden5 sites
Local Institution
Bromma
Local Institution
Gothenburgh
Local Institution
Halmstad
Local Institution
Malmö
Local Institution
Säter
About this study
Official title: A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR)
Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole, Olanzapine or Quetiapine or Risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
Tablets, Oral, 10 - 30 mg, Once daily, 26 weeks.
Olanzapine or Quetiapine or RisperidoneDrug
Olanzapine: Tablets, Oral, 5-20 mg, Once daily, 26 weeks. OR Quetiapine: Tablets, Oral, 100-800 mg, Once daily, 26 weeks. OR Risperidone: Tablets, Oral, 2-8 mg, Once daily, 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: Aripiprazole |
| B1 | Active comparator | Not described Receives: Drug: Olanzapine or Quetiapine or Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Investigator Assessment Questionnaire at week 26
Secondary outcomes (1)
Clinical Global Impression scale and patient preference of medication at endpoint
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 startJul 2004
- Primary completionAug 2005
- Study completionAug 2005
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 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
- 700 participants
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Investigators
- Bruno Millet, MD, Principal investigator, Centre Hospitalier Guillaume Régnier, service de Psychiatrie adultes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237913
- Sponsor's protocol ID
- CN138-152
- Status last verified
- Jul 2008
- First submitted
- 11 Oct 2005
- Last updated
- 8 Nov 2013
- Results posted
- No
Publications
Hanssens L, L'Italien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry. 2008 Dec 22;8:95. doi: 10.1186/1471-244X-8-95.
PubMed 19102734
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 Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR)
- ClinicalTrials.gov ID
- NCT00237913
- Acronym / sponsor ID
- CN138-152
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Jul 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (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.
Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: Aripiprazole |
| B1 | Active comparator | Drug: Olanzapine or Quetiapine or Risperidone |
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 diagnosis of schizophrenia
- Schizophrenia symptoms not optimally controlled or antipsychotic medication not well tolerated
Key exclusion criteria (2 listed)
- Diagnosis of schizoaffective disorder
- Patients treatment-resistant to antipsychotics
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 |
|---|---|---|
| AripiprazoleAlso: AbilifyTablets, Oral, 10 - 30 mg, Once daily, 26 weeks. | Drug | A1 |
| Olanzapine or Quetiapine or RisperidoneOlanzapine: Tablets, Oral, 5-20 mg, Once daily, 26 weeks. OR Quetiapine: Tablets, Oral, 100-800 mg, Once daily, 26 weeks. OR Risperidone: Tablets, Oral, 2-8 mg, Once daily, 26 weeks. | Drug | B1 |
Primary outcome
Score on the Investigator Assessment Questionnaire at week 26
1 secondary outcome
Clinical Global Impression scale and patient preference of medication at endpoint
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.
- Derived from this study: PubMed 19102734Hanssens L, L'Italien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry. 2008 Dec 22;8:95. doi: 10.1186/1471-244X-8-95.
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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.
Bruno Millet, MD principal investigator
Centre Hospitalier Guillaume Régnier, service de Psychiatrie adultes
33 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole and Olanzapine or Quetiapine or Risperidone in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 33 sites in 9 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 33 sites in France, United Kingdom, Germany, Sweden, Denmark and 4 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. 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?
Score on the Investigator Assessment Questionnaire at week 26. 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 NCT00237913, 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 8 Nov 2013.