SchizophreniaPhase 4NCT00406315
Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone
A Phase 4 study testing ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 40 sites in 6 countries.
Trial summary
The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- ziprasidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 40 sitesin 6 countries
- Study dates
- Nov 2006to Mar 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females, between 18 and 55 years of age, at the time of consent.
- Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)
- Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.
Who cannot join
- Subjects who are unable to provide informed consent
- Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
- Females who are pregnant, breast feeding, or lactating at screening.
Trial locations and contacts
40 sites in 6 countries.
40 sites in 6 countries
United States28 sites
Pfizer Investigational Site
Bothell, Washington, 98011
Pfizer Investigational Site
Chicago, Illinois, 60640
Pfizer Investigational Site
Costa Mesa, California, 92626
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Des Plaines, Illinois, 60016
Pfizer Investigational Site
DeSoto, Texas, 75115
Pfizer Investigational Site
Garden Grove, California, 92845
Pfizer Investigational Site
Hialeah, Florida, 33016
Pfizer Investigational Site
Kirkland, Washington, 98033
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
Memphis, Tennessee, 38117
Pfizer Investigational Site
Memphis, Tennessee, 38133
Pfizer Investigational Site
Miami, Florida, 33126
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Nashua, New Hampshire, 03060
Pfizer Investigational Site
National City, California, 91950
Pfizer Investigational Site
Oakbrook Terrace, Illinois, 60181
Pfizer Investigational Site
Olean, New York, 14760
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Orange, California, 92868-8040
Pfizer Investigational Site
Phoenix, Arizona, 85028
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Schaumburg, Illinois, 60194
Pfizer Investigational Site
St Louis, Missouri, 63368
Pfizer Investigational Site
Staten Island, New York, 10312
Pfizer Investigational Site
Temecula, California, 92591
Pfizer Investigational Site
Topeka, Kansas, 66606
Pfizer Investigational Site
Torrance, California, 90505
Germany4 sites
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Düsseldorf, 40629
Pfizer Investigational Site
Hamburg, 20246
Pfizer Investigational Site
München, 80336
Brazil3 sites
Pfizer Investigational Site
Aparecida de Goiânia, Goiás, 74922-810
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 22290-140
Pfizer Investigational Site
São Paulo, São Paulo, 05403-010
Greece2 sites
Pfizer Investigational Site
Athens, 10676
Pfizer Investigational Site
Thessaloniki, 546 42
Turkey (Türkiye)2 sites
Pfizer Investigational Site
Ankara, 06200
Pfizer Investigational Site
İzmit, 41380
About this study
Official title: A Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder
The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- ziprasidone
- Keywords
- ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidoneDrug
Also called Geodon, Zeldox
Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
| Study group | Role | What they receive |
|---|---|---|
| A1 | Other | atypical antipsychotic for the treatment of schizophrenia Receives: Drug: ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weight at Week 16
Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
Measured: Baseline, Week 16, Week 16 LOCF
Secondary outcomes (14)
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
Total cholesterol value: Change = value at Week 16 minus value at Baseline.
Measured: Baseline, Week 16
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.
Measured: Baseline, Week 16
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
HbAlc value: Change = value at Week 16 minus value at Baseline.
Measured: Baseline, Week 16
Change From Baseline in Fasting Glucose at Week 16
Fasting glucose value: Change = value at Week 16 minus value at Baseline.
Measured: Baseline, Week 16
Change From Baseline in Fasting Insulin at Week 16
Fasting insulin value: Change = value at Week 16 minus value at Baseline.
Measured: Baseline, Week 16
Change From Baseline in Waist and Hip Circumference at Week 16
Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.
Measured: Baseline, Week 16
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.
Measured: Baseline, Week 16
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.
Measured: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Measured: Baseline, Week 16, Week 16 LOCF
Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Measured: Week 16, Week 16 LOCF
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Measured: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Measured: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Measured: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Measured: Baseline, Week 16, Week 16 LOCF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 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
- NCT00406315
- Sponsor's protocol ID
- A1281148
- Status last verified
- Mar 2021
- First submitted
- 29 Nov 2006
- Last updated
- 29 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00406315
- Acronym / sponsor ID
- A1281148
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Posted 2 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A1 | Other | Drug: ziprasidoneatypical antipsychotic for the treatment of schizophrenia |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males or females, between 18 and 55 years of age, at the time of consent.
- Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)
- Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.
Key exclusion criteria (3 listed)
- Subjects who are unable to provide informed consent
- Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
- Females who are pregnant, breast feeding, or lactating at screening.
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 |
|---|---|---|
| ziprasidoneAlso: Geodon, ZeldoxDays 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase | Drug | A1 |
Primary outcome
Change From Baseline in Weight at Week 16
Time frame: Baseline, Week 16, Week 16 LOCF
Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
14 secondary outcomes
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
Time frame: Baseline, Week 16
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Fasting Glucose at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Fasting Insulin at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Waist and Hip Circumference at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
Time frame: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
Time frame: Baseline, Week 16, Week 16 LOCF
Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
Time frame: Week 16, Week 16 LOCF
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
Time frame: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
Time frame: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
Time frame: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Time frame: Baseline, Week 16, Week 16 LOCF
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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
40 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 40 sites in 6 countries.
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 3 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 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Germany, Brazil, Greece, Turkey (Türkiye) and 1 more country. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Weight at Week 16 (time frame: Baseline, Week 16, Week 16 LOCF). 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 29 Mar 2021.