A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule

NCT01053429 | Completed Results

• 1 other identifier: A1281140
• Study Type: observational
• Target: 3,391
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy) signals will be checked at every visit during the contracted study period until the maximum study end date, per the protocol, of April 2010.

Conditions

Bipolar Disorder; Schizophrenia

Keywords

Regulatory Post-Marketing Surveillance; Regulatory Pharmacovigilance; ziprasidone

Outcome Measures

Primary Outcomes (4)

• Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population

  CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.

  Baseline up to Week 8

• Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population

  CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.

  Baseline up to Week 8

• Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT

  CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.

  Baseline up to Week 8

• Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP

  CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.

  Baseline up to Week 8

Other Outcomes (2)

• Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement

  Baseline up to Week 8

• Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement

  Baseline up to Week 8

Study Arms (1)

observational cohort

Drug: ziprasidone

Interventions

ziprasidone DRUG

This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.

Also known as: Geodon, Zeldox

observational cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.

You may qualify if:

• Patients diagnosed with schizophrenia

You may not qualify if:

• Patients who have known hypersensitivity to any ingredient of the product
• Patients who have had a recent acute myocardial infarction
• Patients who have uncompensated heart failure
• Patients who have conditions with a potential to increase QT interval (QT-interval prolongation or history of QT prolongation; congenital long QT syndrome; use with other drugs known to increase the QT interval; arrhythmias treated with class I and III antiarrhythmic drugs)

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Limitations and Caveats

Per the Statistical Analysis Plan Amendment CGI-S and CGI-I endpoints analyzed as frequency counts (categorical) rather than the planned CGI-S mean change from baseline and CGI-I mean scores (continuous); any additional analyses would be exploratory.

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: June 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 3, 2021
• Results First Posted: January 7, 2011

Record last verified: 2021-03