NCT00579670

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 17, 2010

Completed
Last Updated

March 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

December 20, 2007

Results QC Date

April 2, 2010

Last Update Submit

February 18, 2021

Conditions

Keywords

Ziprasidone in patients with schizophrenia

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline

  • Summary of Metabolic Risk Factors

    Baseline

  • Summary of Most Frequently Used Concomitant Drug Treatments

    Most frequently concomitant drug treatments used by \>15 participants.

    Baseline

Secondary Outcomes (20)

  • Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)

    Week 12

  • Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)

    Baseline, Week 12

  • Positive and Negative Syndrome Scale (PANSS) - Positive Subscale

    Baseline, Week 12

  • PANSS - Negative Subscale

    Baseline, Week 12

  • PANSS - Composite Subscale

    Baseline, Week 12

  • +15 more secondary outcomes

Other Outcomes (1)

  • Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period

    Week 12

Interventions

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

Also known as: Geodon, Zeldox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with schizophrenia

You may qualify if:

  • Usual clinical practice of physician

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Pfizer Investigational Site

Athens, 12461, Greece

Location

Pfizer Investigational Site

Chaïdári, 124 61, Greece

Location

Pfizer Investigational Site

Chaïdári, 12461, Greece

Location

Pfizer Investigational Site

Chaïdári, 12462, Greece

Location

Pfizer Investigational Site

Corfu, 49100, Greece

Location

Pfizer Investigational Site

Crete, 731-00, Greece

Location

Pfizer Investigational Site

Giannitsá, 58100, Greece

Location

Pfizer Investigational Site

Haidari, 12461, Greece

Location

Pfizer Investigational Site

Kalamata, 24100, Greece

Location

Pfizer Investigational Site

Katerini, 60100, Greece

Location

Pfizer Investigational Site

Kozani, 50100, Greece

Location

Pfizer Investigational Site

Kozani, Greece

Location

Pfizer Investigational Site

Lamia, 35100, Greece

Location

Pfizer Investigational Site

Larissa, Greece

Location

Pfizer Investigational Site

Pátrai, 26000, Greece

Location

Pfizer Investigational Site

Pátrai, 26001, Greece

Location

Pfizer Investigational Site

Thessaloniki, 564-29, Greece

Location

Pfizer Investigational Site

Thessaloniki, 56430, Greece

Location

Pfizer Investigational Site

Thessaloniki, 57010, Greece

Location

Pfizer Investigational Site

Volos, 38222, Greece

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Limitations and Caveats

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).

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 24, 2007

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

March 10, 2021

Results First Posted

May 17, 2010

Record last verified: 2021-02

Locations