SchizophreniaPhase 4NCT00239109
Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia.
A Phase 4 study testing Ziprasidone, Olanzapine and Scales in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 7 sites in Spain.
Trial summary
Various studies suggest that patients treated with Olanzapine can experience a substantial weight gain, while no changes have been observed in patients treated with Ziprasidone. Negative consequences on lipid and glucose profiles have also been observed in patients treated with Olanzapine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Ziprasidone, Olanzapine and Scales
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- 7 sitesSpain
- Study dates
- Apr 2003to Feb 2007
- 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
- Patients with a primary diagnosis of schizophrenia using the DSM-IV-TR criteria
- Patient's clinical condition should justify treatment initiation with a new antipsychotic drug.
Who cannot join
- Patients at immediate risk of committing harm to self or others
- Concurrent treatment with antipsychotic agents after randomization.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Pfizer Investigational Site
Badajoz
Pfizer Investigational Site
Barcelona
Pfizer Investigational Site
Bilbao, Vizcaya
Pfizer Investigational Site
Madrid
Pfizer Investigational Site
Salamanca
Pfizer Investigational Site
Seville
Pfizer Investigational Site
Zamora
About this study
Official title: Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study.
- Various studies suggest that patients treated with Olanzapine can experience a substantial weight gain, while no changes have been observed in patients treated with Ziprasidone. Negative consequences on lipid and glucose profiles have also been observed in patients treated with Olanzapine. Most of the available data belong to short-term studies. However, for most clinical trials the primary variable was an efficacy variable, and included the weight assessment as a secondary variable; they also lack a systematic monitoring of some variables that can play a role in weight gain, as the level of exercise, appetite increase, etc. and we have considered of importance their inclusion in this protocol. Previous studies did not assess visceral fat using widely standardized parameters as the waist index, which at certain levels is considered an indicator of the cardiovascular risk, or leptine, highly correlated to the body fat storage. We would like to fit the recently published American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists and North American Association for the Study of Obesity Antipsychotic, obesity and diabetes mellitus consensus.22
- Schizophrenic patients show a 4-fold probability to die as a consequence of cardiovascular problems compared to the normal population. The antipsychotic treatment can contribute to increase this risk favoring weight gain and the appearance of cardiovascular risk factors associated to obesity (blood hypertension, hyperlipidemia, type II Diabetes Mellitus). We intend to obtain a complete cardiovascular risk profile of patients, as well as its change during antipsychotic treatment, including primary cardiovascular risk factors in addition to the analysis of markers that have recently been linked to cardiovascular risk (as reactive protein C).
- The study will evaluate the risk of hyperglycemia, insulin resistance and Diabetes Mellitus, and will investigate the association between glucose homeostasis abnormalities and weight gain in the treated patients. Likewise, adiponectine, secreted from adipocytes and a possible link between obesity and insulin resistance will be determined; recent studies show an adiponectine decrease in humans with insulin resistance and obesity; furthermore, prospective studies have shown these changes could predict a higher risk of DM development.
- Changes have been introduced in the complete evaluation of the patient's metabolic and cardiovascular profiles with the advice, and under the coordination of endocrinologists after a complete review of the subject
- Conditions
- Schizophrenia
- Being tested
- Ziprasidone, Olanzapine, Scales, measures of the body (Weight...), Serum analysis
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiprasidoneDrug
OlanzapineDrug
ScalesProcedure or surgery
measures of the body (Weight...)Procedure or surgery
Serum analysisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate and compare the effects of ziprasidone vs olanzapine on body weight in the treatment of patients with schizophrenia.
Secondary outcomes (1)
PANSS total score; change from baseline CGI severity; change from baseline CGI - Improvement PANSS negative subscale score; change from baseline DSM IV axis V Patient preference scale (PPS) Heath Utility Index Mark III BMI , Qaist Index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startApr 2003
- Study completionFeb 2007
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
- Enrolment
- 112 participants
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
- NCT00239109
- Sponsor's protocol ID
- A1281064
- Status last verified
- Feb 2021
- First submitted
- 12 Oct 2005
- Last updated
- 21 Feb 2021
- Results posted
- 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
- Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study.
- ClinicalTrials.gov ID
- NCT00239109
- Acronym / sponsor ID
- A1281064
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Feb 2007
- First posted
- 14 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.
- Various studies suggest that patients treated with Olanzapine can experience a substantial weight gain, while no changes have been observed in patients treated with Ziprasidone. Negative consequences on lipid and glucose profiles have also been observed in patients treated with Olanzapine. Most of the available data belong to short-term studies. However, for most clinical trials the primary variable was an efficacy variable, and included the weight assessment as a secondary variable; they also lack a systematic monitoring of some variables that can play a role in weight gain, as the level of exercise, appetite increase, etc. and we have considered of importance their inclusion in this protocol. Previous studies did not assess visceral fat using widely standardized parameters as the waist index, which at certain levels is considered an indicator of the cardiovascular risk, or leptine, highly correlated to the body fat storage. We would like to fit the recently published American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists and North American Association for the Study of Obesity Antipsychotic, obesity and diabetes mellitus consensus.22
- Schizophrenic patients show a 4-fold probability to die as a consequence of cardiovascular problems compared to the normal population. The antipsychotic treatment can contribute to increase this risk favoring weight gain and the appearance of cardiovascular risk factors associated to obesity (blood hypertension, hyperlipidemia, type II Diabetes Mellitus). We intend to obtain a complete cardiovascular risk profile of patients, as well as its change during antipsychotic treatment, including primary cardiovascular risk factors in addition to the analysis of markers that have recently been linked to cardiovascular risk (as reactive protein C).
- The study will evaluate the risk of hyperglycemia, insulin resistance and Diabetes Mellitus, and will investigate the association between glucose homeostasis abnormalities and weight gain in the treated patients. Likewise, adiponectine, secreted from adipocytes and a possible link between obesity and insulin resistance will be determined; recent studies show an adiponectine decrease in humans with insulin resistance and obesity; furthermore, prospective studies have shown these changes could predict a higher risk of DM development.
- Changes have been introduced in the complete evaluation of the patient's metabolic and cardiovascular profiles with the advice, and under the coordination of endocrinologists after a complete review of the subject
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a primary diagnosis of schizophrenia using the DSM-IV-TR criteria
- Patient's clinical condition should justify treatment initiation with a new antipsychotic drug.
Key exclusion criteria (2 listed)
- Patients at immediate risk of committing harm to self or others
- Concurrent treatment with antipsychotic agents after randomization.
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 |
|---|---|---|
| Ziprasidone | Drug | – |
| Olanzapine | Drug | – |
| Scales | Procedure or surgery | – |
| measures of the body (Weight...) | Procedure or surgery | – |
| Serum analysis | Procedure or surgery | – |
Primary outcome
To estimate and compare the effects of ziprasidone vs olanzapine on body weight in the treatment of patients with schizophrenia.
1 secondary outcome
PANSS total score; change from baseline CGI severity; change from baseline CGI - Improvement PANSS negative subscale score; change from baseline DSM IV axis V Patient preference scale (PPS) Heath Utility Index Mark III BMI , Qaist Index
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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
7 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 Ziprasidone, Olanzapine and Scales in people with Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 7 sites in Spain.
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 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 7 sites in Spain. 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?
To estimate and compare the effects of ziprasidone vs olanzapine on body weight in the treatment of patients with schizophrenia.. 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.