SchizophreniaPhase 4NCT00329810
Effect on Cognitive Function of a Treatment With Aripiprazole
A Phase 4 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
Trial summary
To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Mar 2006
- Phase
- Phase 4
- 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
- Diagnosis of Schizophrenia
- score of 2-6 in the CGI-S scale at basline
- ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment
Who cannot join
- women of child bearing potential
- women pregnant or breast feeding
- patients with a score of 0,-1 or 7
- substance use
About this study
Official title: A Prospective, Multicenter, Open-Label Study to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients
To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.
- 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
Also called Abilify
Tablets, oral, 15 mg, once daily, 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Switch | Experimental | Not described Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression scale at endpoint
Secondary outcomes (1)
Change in Clinical Global Impression scale and cognition scales at endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startMar 2005
- Primary completionMar 2006
- Study completionMar 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Investigators
- Bristol-Myers Squibb, Principal investigator, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329810
- Sponsor's protocol ID
- CN138-166
- Status last verified
- Feb 2012
- First submitted
- 12 Sep 2005
- Last updated
- 8 Nov 2013
- Results posted
- No
Publications
Bervoets C, Morrens M, Vansteelandt K, Kok F, de Patoul A, Halkin V, Pitsi D, Constant E, Peuskens J, Sabbe B. Effect of aripiprazole on verbal memory and fluency in schizophrenic patients : results from the ESCAPE study. CNS Drugs. 2012 Nov;26(11):975-82. doi: 10.1007/s40263-012-0003-4.
PubMed 23018547
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 to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00329810
- Acronym / sponsor ID
- CN138-166
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Mar 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 25 May 2006 (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.
To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Switch | Experimental | Drug: Aripiprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Schizophrenia
- score of 2-6 in the CGI-S scale at basline
- ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment
Key exclusion criteria (4 listed)
- women of child bearing potential
- women pregnant or breast feeding
- patients with a score of 0,-1 or 7
- substance use
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, 15 mg, once daily, 12 weeks. | Drug | Switch |
Primary outcome
Clinical Global Impression scale at endpoint
1 secondary outcome
Change in Clinical Global Impression scale and cognition scales 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 23018547Bervoets C, Morrens M, Vansteelandt K, Kok F, de Patoul A, Halkin V, Pitsi D, Constant E, Peuskens J, Sabbe B. Effect of aripiprazole on verbal memory and fluency in schizophrenic patients : results from the ESCAPE study. CNS Drugs. 2012 Nov;26(11):975-82. doi: 10.1007/s40263-012-0003-4.
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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.
Bristol-Myers Squibb principal investigator
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
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 3 inclusion and 4 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.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 scale at endpoint. 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 NCT00329810, 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.