SchizophreniaPhase 4NCT00634348
A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients
A Phase 4 study testing Aripiprazole and Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 41 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole and Ziprasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 41 sitesUnited States
- Study dates
- Apr 2004to Mar 2005
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with schizophrenia or schizoaffective disorder
- At least a 6th grade reading level
- Males or females, between 18 and 70 years of age at the time of consent
- Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening
Who cannot join
- Psychiatric disorder other than schizophrenia or schizoaffective disorder
- History of arrhythmia, heart attack, or heart failure
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Pfizer Investigational Site
Anaheim, California, 92804
Pfizer Investigational Site
Arlington, Virginia, 22204
Pfizer Investigational Site
Arlington, Virginia, 22205
Pfizer Investigational Site
Baltimore, Maryland, 21202
Pfizer Investigational Site
Bellaire, Texas, 77401
Pfizer Investigational Site
Butner, North Carolina, 27509
Pfizer Investigational Site
Cerritos, California, 90703
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7160
Pfizer Investigational Site
Cincinnati, Ohio, 45220
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559
Pfizer Investigational Site
Clementon, New Jersey, 08021
Pfizer Investigational Site
Culver City, California, 90232
Pfizer Investigational Site
Dallas, Texas, 75228
Pfizer Investigational Site
Durham, North Carolina, 27705
Pfizer Investigational Site
Falls Church, Virginia, 22041
Pfizer Investigational Site
Garden Grove, California, 92845
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
Hialeah, Florida, 33016
Pfizer Investigational Site
Houston, Texas, 77008
Pfizer Investigational Site
Irving, Texas, 75062
Pfizer Investigational Site
Jamaica, New York, 11418
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Newport Beach, California, 92663
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73118
Pfizer Investigational Site
Paramount, California, 90723
Pfizer Investigational Site
Princeton, New Jersey, 08540
Pfizer Investigational Site
Raleigh, North Carolina, 27603
Pfizer Investigational Site
Riverside, California, 92506
Pfizer Investigational Site
Rockville, Maryland, 20850
Pfizer Investigational Site
San Diego, California, 92105
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
San Diego, California, 92126
Pfizer Investigational Site
Shreveport, Louisiana, 71101
Pfizer Investigational Site
St Louis, Missouri, 63104
Pfizer Investigational Site
St Louis, Missouri, 63118
Pfizer Investigational Site
Staten Island, New York, 10305
Pfizer Investigational Site
Torrance, California, 90505
Pfizer Investigational Site
Upland, California, 91786
Pfizer Investigational Site
Washington D.C., District of Columbia, 20016
Pfizer Investigational Site
Willingboro, New Jersey, 08046
Pfizer Investigational Site
Woodlane, New Jersey, 08060
About this study
Official title: A Four-Week Double Blind Multicenter Study Comparing The Efficacy And Safety Of Ziprasidone To Aripiprazole In Subjects With Schizophrenia Or Schizoaffective Disorder Needing Inpatient Care
The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole, Ziprasidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days
ZiprasidoneDrug
Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Active comparator | Not described Receives: Drug: Aripiprazole |
| Ziprasidone | Active comparator | Not described Receives: Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
Measured: 28 days
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.
Measured: 28 days
Secondary outcomes (16)
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.
Measured: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.
Measured: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.
Measured: 28 days
Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.
Measured: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.
Measured: 28 days
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.
Measured: 28 days
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.
Measured: 28 days
Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.
Measured: 28 days
Change from baseline to endpoint in Patient Preference Scale (PPS) scores.
Measured: 28 days
Change from baseline to endpoint in Life Skills Profile (LSP).
Measured: 28 days
Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28.
Measured: 28 days
Change from baseline to endpoint in Cognitive Battery.
Measured: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.
Measured: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores.
Measured: 28 days
Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.
Measured: 28 days
Change from baseline to Day 28 in movement disorder rating scale scores.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startApr 2004
- Study completionMar 2005
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634348
- Sponsor's protocol ID
- A1281110
- Status last verified
- Feb 2021
- First submitted
- 5 Mar 2008
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-Week Double Blind Multicenter Study Comparing The Efficacy And Safety Of Ziprasidone To Aripiprazole In Subjects With Schizophrenia Or Schizoaffective Disorder Needing Inpatient Care
- ClinicalTrials.gov ID
- NCT00634348
- Acronym / sponsor ID
- A1281110
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Mar 2005 (actual)
- First posted
- 13 Mar 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 safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Active comparator | Drug: Aripiprazole |
| Ziprasidone | Active comparator | Drug: Ziprasidone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients with schizophrenia or schizoaffective disorder
- At least a 6th grade reading level
- Males or females, between 18 and 70 years of age at the time of consent
- Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening
Key exclusion criteria (2 listed)
- Psychiatric disorder other than schizophrenia or schizoaffective disorder
- History of arrhythmia, heart attack, or heart failure
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 |
|---|---|---|
| AripiprazoleOral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days | Drug | Aripiprazole |
| ZiprasidoneOral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days | Drug | Ziprasidone |
Primary outcome
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
Time frame: 28 days
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.
Time frame: 28 days
16 secondary outcomes
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.
Time frame: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.
Time frame: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.
Time frame: 28 days
Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.
Time frame: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.
Time frame: 28 days
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.
Time frame: 28 days
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.
Time frame: 28 days
Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.
Time frame: 28 days
Change from baseline to endpoint in Patient Preference Scale (PPS) scores.
Time frame: 28 days
Change from baseline to endpoint in Life Skills Profile (LSP).
Time frame: 28 days
Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28.
Time frame: 28 days
Change from baseline to endpoint in Cognitive Battery.
Time frame: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.
Time frame: 28 days
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores.
Time frame: 28 days
Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.
Time frame: 28 days
Change from baseline to Day 28 in movement disorder rating scale scores.
Time frame: 28 days
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 21 Feb 2021.
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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.
Pfizer CT.gov Call Center study director
Pfizer
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole and Ziprasidone in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 41 sites in United States.
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 4 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. 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 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?
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores. (time frame: 28 days). 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?
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 21 Feb 2021.