SchizophreniaPhase 3NCT00712686
Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
A Phase 3 study testing Aripiprazole and Olanzapine in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
Trial summary
The purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- No sites listed yet
- Study dates
- Jun 2000to Dec 2003
- 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
- Patients with DSM-IV diagnosis of schizophrenia patients in acute relapse
- Treated as outpatients for at least one continuous 3-month period during the past 12 months
- PANSS total score ≥60
- Previously responsive to neuroleptics (other than clozapine)
- Able to give informed consent and comprehend and satisfactorily comply with the protocol requirements
Who cannot join
- An Axis I (DSM-IV) diagnosis of schizoaffective disorder
- A clinical picture and/or history that was consistent with: (a) Delirium, dementia, amnestic or other cognitive disorders; (b) Bipolar disorder; (c)personality disorder
- Nonresponsive to prior olanzapine therapy
- Likely to require prohibited concomitant therapy
- DSM-IV criteria for any significant substance abuse within the past three months, including addiction to cocaine or alcohol
- Known to be allergic or hypersensitive to study drugs
Show all 10Show fewer
- Represented a significant risk of committing suicide based on history or mental status exam
- Unstable thyroid pathology and treatment within the past six months
- A history or evidence of a medical condition that would expose the patient to an undue risk
- Clinically significant abnormal laboratory test results (including urine drug screen), vital sign, or ECG findings
About this study
Official title: A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
The purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole, Olanzapine
- 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, 15-30 mg, once daily, 140 weeks
OlanzapineDrug
Capsule, Oral, 10-20 mg, once daily, 140 weeks
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: Aripiprazole |
| B1 | Active comparator | Not described Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in the PANSS Total Score
Measured: from baseline to Week 6
The percentage of patients showing significant weight gain (a≥ 7% increase)
Measured: from baseline to Week 26
Secondary outcomes (9)
Change from baseline on the CGI-S Score
Measured: at the end of study
Change from baseline on PANSS Total Score
Measured: at the end of study
Change from baseline on PANSS-Positive Scale Total Score
Measured: at the end of study
Change from baseline on PANSS-Negative Scale Total Score
Measured: at the end of study
Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score
Measured: at the end of study
Mean CGI-I Score
Measured: at the end of study
Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I)
Measured: at the end of study
Change from baseline on the MADRS
Measured: at the end of study
Safety and tolerability
Measured: at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startJun 2000
- Primary completionDec 2003
- Study completionDec 2003
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712686
- Sponsor's protocol ID
- CN138-003
- Status last verified
- Jun 2010
- First submitted
- 8 Jul 2008
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fleischhacker WW, McQuade RD, Marcus RN, Archibald D, Swanink R, Carson WH. A double-blind, randomized comparative study of aripiprazole and olanzapine in patients with schizophrenia. Biol Psychiatry. 2009 Mar 15;65(6):510-7. doi: 10.1016/j.biopsych.2008.07.033. Epub 2008 Nov 4.
PubMed 18986646
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, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
- ClinicalTrials.gov ID
- NCT00712686
- Acronym / sponsor ID
- CN138-003
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2000
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 10 Jul 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 purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: Aripiprazole |
| B1 | Active comparator | Drug: Olanzapine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with DSM-IV diagnosis of schizophrenia patients in acute relapse
- Treated as outpatients for at least one continuous 3-month period during the past 12 months
- PANSS total score ≥60
- Previously responsive to neuroleptics (other than clozapine)
- Able to give informed consent and comprehend and satisfactorily comply with the protocol requirements
Key exclusion criteria (10 listed)
- An Axis I (DSM-IV) diagnosis of schizoaffective disorder
- A clinical picture and/or history that was consistent with: (a) Delirium, dementia, amnestic or other cognitive disorders; (b) Bipolar disorder; (c)personality disorder
- Nonresponsive to prior olanzapine therapy
- Likely to require prohibited concomitant therapy
- DSM-IV criteria for any significant substance abuse within the past three months, including addiction to cocaine or alcohol
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, 15-30 mg, once daily, 140 weeks | Drug | A1 |
| OlanzapineCapsule, Oral, 10-20 mg, once daily, 140 weeks | Drug | B1 |
Primary outcome
The mean change in the PANSS Total Score
Time frame: from baseline to Week 6
The percentage of patients showing significant weight gain (a≥ 7% increase)
Time frame: from baseline to Week 26
9 secondary outcomes
Change from baseline on the CGI-S Score
Time frame: at the end of study
Change from baseline on PANSS Total Score
Time frame: at the end of study
Change from baseline on PANSS-Positive Scale Total Score
Time frame: at the end of study
Change from baseline on PANSS-Negative Scale Total Score
Time frame: at the end of study
Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score
Time frame: at the end of study
Mean CGI-I Score
Time frame: at the end of study
Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I)
Time frame: at the end of study
Change from baseline on the MADRS
Time frame: at the end of study
Safety and tolerability
Time frame: at the end of study
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.
- Background: PubMed 18986646Fleischhacker WW, McQuade RD, Marcus RN, Archibald D, Swanink R, Carson WH. A double-blind, randomized comparative study of aripiprazole and olanzapine in patients with schizophrenia. Biol Psychiatry. 2009 Mar 15;65(6):510-7. doi: 10.1016/j.biopsych.2008.07.033. Epub 2008 Nov 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 study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole and Olanzapine 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 5 inclusion and 10 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 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?
The mean change in the PANSS Total Score (time frame: from baseline to Week 6). The study lists 2 primary outcomes in all. 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 NCT00712686, 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.