Schizophrenia
Conditions
Brief summary
Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone
Interventions
DRUGZiprasidone
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
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ziprasidone Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative reason/Other | 2 |
| Overall Study | Adverse Event | 19 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | Ziprasidone |
|---|---|
| Age, Continuous | 41.1 years STANDARD_DEVIATION 13.3 |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 36 / 43 |
| serious Total, serious adverse events | 13 / 43 |
Outcome results
Primary
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.
Time frame: Baseline, up to 5 years (End of Study [LOCF])
Population: ITT. LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ziprasidone | Change From Baseline in CGI-I at End of Study (up to 5 Years) | 1.4 score on a scale | Standard Deviation 1.6 |
Primary
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.
Time frame: Baseline, up to 5 years (End of Study [LOCF])
Population: ITT. LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ziprasidone | Change From Baseline in CGI-S at End of Study (up to 5 Years) | 0.9 score on a scale | Standard Deviation 1.5 |
Primary
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.
Time frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
Population: Intention to treat (ITT), all patients who received at least one dose of study medication and who have at least one post baseline efficacy evaluation. Imputation at Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Baseline (n=43): very much improved | 13 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | Baseline (n=43): much improved | 30 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 3 months (n=35): very much improved | 10 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 3 months (n=35): much improved | 20 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 3 months (n=35): minimally improved | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 3 months (n=35): no change | 3 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 6 months (n=34): very much improved | 11 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 6 months (n=34): much improved | 18 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 6 months (n=34): minimally improved | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 6 months (n=34): no change | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 6 months (n=34): minimally worsened | 1 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 1 year (n=27): very much improved | 7 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 1 year (n=27): much improved | 16 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 1 year (n=27): minimally improved | 1 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 1 year (n=27): no change | 3 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 3 years (n=10): very much improved | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 3 years (n=10): much improved | 5 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 3 years (n=10): no change | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 3 years (n=10): minimally worsened | 1 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 5 years (n=7): very much improved | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 5 years (n=7): much improved | 4 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | 5 years (n=7): minimally improved | 1 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | End of Study [LOCF] (n=43): very much improved | 5 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | End of Study [LOCF] (n=43): much improved | 17 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | End of Study [LOCF] (n=43): minimally improved | 5 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | End of Study [LOCF] (n=43): no change | 6 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | End of Study [LOCF] (n=43): minimally worsened | 4 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) | End of Study [LOCF] (n=43): much worsened | 6 participants |
Primary
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).
Time frame: Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF]
Population: ITT. LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 3 years (n=10): borderline | 5 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Baseline (n=43): normal, not ill at all | 4 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Baseline (n=43): borderline | 20 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Baseline (n=43): mildly ill | 14 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Baseline (n=43): moderately ill | 4 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | Baseline (n=43): markedly ill | 1 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 3 months (n=35): normal, not ill at all | 6 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 3 months (n=35): borderline | 13 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 3 months (n=35): mildly ill | 10 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 3 months (n=35): moderately ill | 6 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 6 months (n=34): normal, not ill at all | 8 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 6 months (n=34): borderline | 10 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 6 months (n=34): mildly ill | 11 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 6 months (n=34): moderately ill | 5 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 1 year (n=27): normal, not ill at all | 6 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 1 year (n=27): borderline | 10 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 1 year (n=27): mildly ill | 9 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 1 year (n=27): moderately ill | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 3 years (n=10): normal, not ill at all | 1 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 3 years (n=10): mildly ill | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 3 years (n=10): moderately ill | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 5 years (n=7): normal, not ill at all | 1 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 5 years (n=7): borderline | 4 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | 5 years (n=7): mildly ill | 2 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | End of Study [LOCF] (n=43): normal, not ill at all | 4 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | End of Study [LOCF] (n=43): borderline | 9 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | End of Study [LOCF] (n=43): mildly ill | 9 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | End of Study [LOCF] (n=43): moderately ill | 10 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | End of Study [LOCF] (n=43):markedly ill | 8 participants |
| Ziprasidone | Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) | End of Study [LOCF] (n=43): severely ill | 3 participants |
Secondary
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.
Time frame: Baseline, up to 5 years (End of Study)
Population: ITT. n= number of participants with analyzable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ziprasidone | Change From Baseline in Drug Attitude Inventory (DAI) at End of Study (up to 5 Years) | -3.3 score on a scale | Standard Deviation 4.6 |
Secondary
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.
Time frame: Baseline, up to 5 years (End of Study)
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ziprasidone | Number of Participants With Scores on Patient Preference Scale (PPS) | Baseline (n=43): much better | 28 participants |
| Ziprasidone | Number of Participants With Scores on Patient Preference Scale (PPS) | Baseline (n=43): slightly better | 13 participants |
| Ziprasidone | Number of Participants With Scores on Patient Preference Scale (PPS) | Baseline (n=43): about the same | 2 participants |
| Ziprasidone | Number of Participants With Scores on Patient Preference Scale (PPS) | End of study (n=28): much better | 4 participants |
| Ziprasidone | Number of Participants With Scores on Patient Preference Scale (PPS) | End of study (n=28): slightly better | 8 participants |
| Ziprasidone | Number of Participants With Scores on Patient Preference Scale (PPS) | End of study (n=28): about the same | 8 participants |
| Ziprasidone | Number of Participants With Scores on Patient Preference Scale (PPS) | End of study (n=28): slightly worse | 3 participants |
| Ziprasidone | Number of Participants With Scores on Patient Preference Scale (PPS) | End of study (n=28): much worse | 5 participants |