Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
NCT ID: NCT00712686
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
690 participants
INTERVENTIONAL
2000-06-30
2003-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A1
Aripiprazole
Tablets, Oral, 15-30 mg, once daily, 140 weeks
B1
Olanzapine
Capsule, Oral, 10-20 mg, once daily, 140 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aripiprazole
Tablets, Oral, 15-30 mg, once daily, 140 weeks
Olanzapine
Capsule, Oral, 10-20 mg, once daily, 140 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bristol-Myers Squibb
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CN138-003
Identifier Type: -
Identifier Source: org_study_id