Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Ziprasidone

• Registration Number: NCT00174447
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-10-15
• Results First Submitted QC: 2009-10-15
• Results First Posted: 2009-11-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.

Exclusion Criteria

• All other patients who do not fit the inclusion criteria as stated above.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A1	Ziprasidone	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)	Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]	CGI-I consists of a 7-point clinician rated scale ranging from 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.
Change From Baseline in CGI-I at End of Study (up to 5 Years)	Baseline, up to 5 years (End of Study [LOCF])	CGI-I consists of a 7-point clinician rated scale ranging from 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. Change from baseline is score at observation minus score at baseline.
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)	Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]	CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assessed investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Change From Baseline in CGI-S at End of Study (up to 5 Years)	Baseline, up to 5 years (End of Study [LOCF])	CGI-S Scale: standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Score: 1 (normal - not ill at all) to 7 (among the most extremely ill). Change: score at observation minus score at baseline.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Scores on Patient Preference Scale (PPS)	Baseline, up to 5 years (End of Study)	Patient rated satisfaction scale with responses: Much better, I prefer this medication, Slightly better, About the same, Slightly worse, and Much worse, I much preferred my previous medication.
Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)	Baseline, up to 5 years (End of Study)	DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance. Change: score at observation minus score at baseline.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Versailles, France