SchizophreniaTRITONNCT00579670

Treatment of Schizophrenic Patients With Ziprasidone

An observational study of Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 20 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine whether ziprasidone provides good efficacy and tolerability in the treatment of schizophrenic Greek patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Schizophrenia
What is being tested?: Ziprasidone
Type of treatment: Pill or oral medicine, Injection or infusion
How many people: 450 participants
Where: 20 sitesGreece
Study dates: Oct 2007to Apr 2009
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients diagnosed with schizophrenia

Who may be able to join

Usual clinical practice of physician

Who cannot join

None

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Greece20 sites

Pfizer Investigational Site
Athens, 12461
Pfizer Investigational Site
Chaïdári, 124 61
Pfizer Investigational Site
Chaïdári, 12461
Pfizer Investigational Site
Chaïdári, 12462
Pfizer Investigational Site
Corfu, 49100
Pfizer Investigational Site
Crete, 731-00
Pfizer Investigational Site
Giannitsá, 58100
Pfizer Investigational Site
Haidari, 12461
Pfizer Investigational Site
Kalamata, 24100
Pfizer Investigational Site
Katerini, 60100
Pfizer Investigational Site
Kozani, 50100
Pfizer Investigational Site
Kozani
Pfizer Investigational Site
Lamia, 35100
Pfizer Investigational Site
Larissa
Pfizer Investigational Site
Pátrai, 26000
Pfizer Investigational Site
Pátrai, 26001
Pfizer Investigational Site
Thessaloniki, 564-29
Pfizer Investigational Site
Thessaloniki, 56430
Pfizer Investigational Site
Thessaloniki, 57010
Pfizer Investigational Site
Volos, 38222

Other trials in Greece

About this study

Official title: Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)

To determine whether ziprasidone provides good efficacy and tolerability in the treatment of schizophrenic Greek patients.

Read the detailed description

Sampling Method Details: Non-interventional study (subjects chosen by physician in accordance to their usual practice).

Conditions: Schizophrenia
Being tested: Ziprasidone
Keywords: Ziprasidone in patients with schizophrenia
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZiprasidoneDrug
Also called Geodon, Zeldox
Ziprasidone 20mg, 40mg, 60mg, 80mg capsules, hard; Ziprasidone 10 mg/ml oral suspension Ziprasidone 20mg/ml powder and solvent for the reconstitution of solution for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of Schizophrenia
Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.
Measured: Baseline
Summary of Metabolic Risk Factors
Measured: Baseline
Summary of Most Frequently Used Concomitant Drug Treatments
Most frequently concomitant drug treatments used by >15 participants.
Measured: Baseline

Secondary outcomes (20)

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Measured: Week 12
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)
Measured: Baseline, Week 12
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.
Measured: Baseline, Week 12
PANSS - Negative Subscale
Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.
Measured: Baseline, Week 12
PANSS - Composite Subscale
The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.
Measured: Baseline, Week 12
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"
Measured: Week 12
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"
Measured: Week 12
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"
Measured: Week 12
Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?"
Measured: Week 12
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"
Measured: Week 12
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"
Measured: Week 12
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"
Measured: Week 12
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"
Measured: Week 12
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?"
Measured: Week 12
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"
Measured: Week 12
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?"
Measured: Week 12
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?"
Measured: Week 12
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"
Measured: Week 12
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"
Measured: Week 12
Percent Change From Baseline to Final Visit in Body Weight
Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Apr 2009

First posted24 Dec 2007 (estimated)
Study startOct 2007
Primary completionApr 2009
Study completionApr 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.
Publications (1)Papers the sponsor has linked to this study.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00579670
Sponsor's protocol ID: A1281156
Acronym: TRITON
Status last verified: Feb 2021
First submitted: 20 Dec 2007
Last updated: 10 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wang Z, Pang C, Meng Q, Zhang DZ, Hong ZX, He GB, Yang H, Xiang BD, Li X, Jiang TA, Li K, Tang Z, Huang F, Lu M, Yu XL, Cheng ZG, Liu FY, Han ZY, Dou JP, Wu SS, Yu J, Liang P. Laparoscopic hepatectomy versus microwave ablation for multifocal 3-5 cm hepatocellular carcinoma: a multi-centre, real-world study. Int J Surg. 2024 Nov 1;110(11):6911-6921. doi: 10.1097/JS9.0000000000001398.
PubMed 39699863

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)
ClinicalTrials.gov ID: NCT00579670
Acronym / sponsor ID: TRITON / A1281156
Conditions: Schizophrenia
Keywords: Ziprasidone in patients with schizophrenia
Study type: Observational
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 24 Dec 2007 (estimated)
Results: Posted 17 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine whether ziprasidone provides good efficacy and tolerability in the treatment of schizophrenic Greek patients.

Detailed description

Sampling Method Details: Non-interventional study (subjects chosen by physician in accordance to their usual practice).

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients diagnosed with schizophrenia

Key inclusion criteria (1 listed)

Usual clinical practice of physician

Key exclusion criteria (1 listed)

None

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, ZeldoxZiprasidone 20mg, 40mg, 60mg, 80mg capsules, hard; Ziprasidone 10 mg/ml oral suspension Ziprasidone 20mg/ml powder and solvent for the reconstitution of solution for injection	Drug	–

Primary outcome

Summary of Schizophrenia
Time frame: Baseline
Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.
Summary of Metabolic Risk Factors
Time frame: Baseline
Summary of Most Frequently Used Concomitant Drug Treatments
Time frame: Baseline
Most frequently concomitant drug treatments used by >15 participants.

20 secondary outcomes

Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Time frame: Week 12
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Time frame: Baseline, Week 12
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Time frame: Baseline, Week 12
PANSS - Negative Subscale
Time frame: Baseline, Week 12
PANSS - Composite Subscale
Time frame: Baseline, Week 12
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?"
Time frame: Week 12
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?"
Time frame: Week 12
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?"
Time frame: Week 12
Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?"
Time frame: Week 12
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?"
Time frame: Week 12
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?"
Time frame: Week 12
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?"
Time frame: Week 12
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?"
Time frame: Week 12
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?"
Time frame: Week 12
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?"
Time frame: Week 12
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?"
Time frame: Week 12
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?"
Time frame: Week 12
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?"
Time frame: Week 12
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?"
Time frame: Week 12
Percent Change From Baseline to Final Visit in Body Weight
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 17 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ziprasidone < 80 mg	15	13
Ziprasidone 80 mg to < 120 mg	57	56
Ziprasidone 120 mg to < 160 mg	88	84
Ziprasidone >= 160 mg	285	263
Ziprasidone Unknown	5	5

Primary outcome: Summary of Schizophrenia

Time frame: Baseline. Number. Unit: Participants

Measure	Ziprasidone < 80 mg n = 15	Ziprasidone 80 mg to < 120 mg n = 57	Ziprasidone 120 mg to < 160 mg n = 88	Ziprasidone >= 160 mg n = 285	Ziprasidone Unknown n = 5
Stage: First episode	1	5	9	39	0
Stage: Acute exacerbation	1	2	12	89	2
Stage: Chronic, stable	12	46	54	117	3
Stage: Refractory	1	4	13	40	0
Symptoms: Positive	2	29	47	191	3
Symptoms: Negative	6	13	16	49	0
Symptoms: Depressive	1	9	9	12	0
Symptoms: No predominant symptomatology	6	6	16	32	2

Population analysed: All subjects randomized to a treatment group were included in the Baseline analysis.

Primary outcome: Summary of Metabolic Risk Factors

Time frame: Baseline. Number. Unit: Participants

Measure	Ziprasidone Total n = 450
No metabolic risk factors at Baseline	205
≥1 metabolic risk factors at Baseline	245
1 metabolic risk factor at Baseline	133
2 metabolic risk factors at Baseline	64
≥3 metabolic risk factors at Baseline	48
Fasting glucose level (≥110 mg/dL)	48
Triglycerides (≥150 mg/dL)	76
HDL (men <40 mg/dL; women <50 mg/dL)	77

Population analysed: All subjects randomized to a treatment group were included in this baseline analysis.

Primary outcome: Summary of Most Frequently Used Concomitant Drug Treatments

Time frame: Baseline. Number. Unit: Participants

Measure	Ziprasidone < 80 mg n = 15	Ziprasidone 80 mg to < 120 mg n = 57	Ziprasidone 120 mg to < 160 mg n = 88	Ziprasidone >= 160 mg n = 285	Ziprasidone Unknown n = 5
Akineton	6	11	12	24	0
Aloperidine	0	6	7	13	0
Biperiden	0	2	5	38	0
Clozapine	3	4	5	4	0
Haloperidol	1	4	7	45	1
Lorazepam	0	3	8	33	1
Olanzapine	0	1	6	20	0
Quetiapine	0	4	1	10	1

Population analysed: All subjects randomized to a treatment group were included in this baseline analysis.

20 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ziprasidone < 80 mg	1 of 15 (6.7%)	1 of 15 (6.7%)	Not reported
Ziprasidone 80 mg to < 120 mg	0 of 57 (0%)	0 of 57 (0%)	Not reported
Ziprasidone 120 mg to < 160 mg	0 of 88 (0%)	9 of 88 (10.2%)	Not reported
Ziprasidone >=160 mg	1 of 285 (0.4%)	34 of 285 (11.9%)	Not reported
Ziprasidone Unknown	0 of 5 (0%)	1 of 5 (20%)	Not reported
Within SmPC Ziprasidone < 80 mg	1 of 15 (6.7%)	1 of 15 (6.7%)	Not reported
Within SmPC Ziprasidone 80 to < 120 mg	0 of 56 (0%)	0 of 56 (0%)	Not reported
Within SmPC Ziprasidone 120 to < 160 mg	0 of 83 (0%)	9 of 83 (10.8%)	Not reported
Within SmPC Ziprasidone = 160 mg	1 of 159 (0.6%)	19 of 159 (11.9%)	Not reported
Above SmPC Ziprasidone > 160 mg	0 of 128 (0%)	17 of 128 (13.3%)	Not reported

Limitations and caveats (from the sponsor): Additional descriptive tables were identified as required after review of the originally planned study tables; many subjects included in the tables had received ziprasidone doses above those specified in the summary of product characteristics (SmPC).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39699863Wang Z, Pang C, Meng Q, Zhang DZ, Hong ZX, He GB, Yang H, Xiang BD, Li X, Jiang TA, Li K, Tang Z, Huang F, Lu M, Yu XL, Cheng ZG, Liu FY, Han ZY, Dou JP, Wu SS, Yu J, Liang P. Laparoscopic hepatectomy versus microwave ablation for multifocal 3-5 cm hepatocellular carcinoma: a multi-centre, real-world study. Int J Surg. 2024 Nov 1;110(11):6911-6921. doi: 10.1097/JS9.0000000000001398.
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

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 20 sites in Greece.

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 1 inclusion and 1 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 10 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 20 sites in Greece. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 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?

Summary of Schizophrenia (time frame: Baseline). The study lists 3 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 NCT00579670, 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 10 Mar 2021.