Clinical trial NCT00174447: Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031
Official title: Open Extension Study Evaluating The Long Term Efficacy , Safety And Tolerability Of Oral Ziprasidone In The Treatment Of Patients Who Have Successfully Completed The Previous Ziprasidone Study A1281031
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
timeFrame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
measure: Change From Baseline in CGI-I at End of Study (up to 5 Years)
timeFrame: Baseline, up to 5 years (End of Study [LOCF])
measure: Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
measure: Change From Baseline in CGI-S at End of Study (up to 5 Years)
timeFrame: Baseline, up to 5 years (End of Study [LOCF])
Secondary outcomes:
measure: Number of Participants With Scores on Patient Preference Scale (PPS)
timeFrame: Baseline, up to 5 years (End of Study)
measure: Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years)
timeFrame: Baseline, up to 5 years (End of Study)
Other outcomes:
Locations:
city: Avignon
country: France
facility: Pfizer Investigational Site
city: DOLE Saint YLIE
country: France
facility: Pfizer Investigational Site
city: Lievin
country: France
facility: Pfizer Investigational Site
city: LYON cedex
country: France
facility: Pfizer Investigational Site
city: Montfavet
country: France
facility: Pfizer Investigational Site
city: Orvault
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Saint Egreve Cedex
country: France
facility: Pfizer Investigational Site
city: Saint Remy
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: TOULON cedex
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Versailles
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Geier JL, Karayal ON, Lewis M, Camm JA, Keane M, Kremer CM, Kolluri S, Reynolds R, Eng S, Strom BL. Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: the ziprasidone observational study of cardiac outcomes (ZODIAC). Pharmacoepidemiol Drug Saf. 2011 Nov;20(11):1192-8. doi: 10.1002/pds.2185. Epub 2011 Jul 27.
citation: Strom BL, Faich GA, Reynolds RF, Eng SM, D'Agostino RB, Ruskin JN, Kane JM. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics. J Clin Psychiatry. 2008 Jan;69(1):114-21. doi: 10.4088/jcp.v69n0115.