Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031

Study Overview
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Brief Summary
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Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: Ziprasidone<br>* Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 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. | Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF] | 
| Change From Baseline in CGI-I at End of Study (up to 5 Years) | 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. | Baseline, up to 5 years (End of Study [LOCF]) | 
| Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 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). | Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF] | 
| Change From Baseline in CGI-S at End of Study (up to 5 Years) | 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. | Baseline, up to 5 years (End of Study [LOCF]) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Scores on Patient Preference Scale (PPS) | 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. | Baseline, up to 5 years (End of Study) | 
| Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years) | 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. | Baseline, up to 5 years (End of Study) |