Schizophrenia
Conditions
Keywords
Open-label extension Ziprasidone study in Schizophrenia
Brief summary
To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).
Interventions
DRUGZiprasidone
20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
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 60 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who have successfully completed a ziprasidone clinical study * Patients not hospitalised in an acute psychiatric service * Written, informed consent to participation. * Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception (intrauterine device, implanted contraceptive, oral contraceptive or condom) must be initiated or continued
Exclusion criteria
Psychiatric: * Subjects at immediate risk of committing harm to self or others * Subjects requiring concurrent treatment with non-study antipsychotic agents * Subjects requiring treatment with antidepressants or mood stabilizers * General: * Subjects with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose \< 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study * Acute or chronic heart disease * Clinically significant ECG abnormalities * Subjects with QTc \>= 500 msec (subjects with QTc \>= 450 msec and \< 500 msec should be discussed with the cardiologist who is responsible for all of the centers involved) * Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments) * Subjects with serum K+ or Mg++ outside the normal range * Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator * Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times upper limit) * Pregnant or lactating women * Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends * Subjects unable or unlikely to follow the study protocol * Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds * Known hypersensitivity to ziprasidone or lactose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 72 months | All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported. |
Countries
Italy
Participant flow
Recruitment details
This extension study enrolled eligible subjects with schizophrenia who had successfully completed a previous Phase 3 ziprasidone study (A1281028, A1281044 or A1281045 \[NCT00136994\]), allowing enrolled subjects to continue treatment with ziprasidone for at least 1 year or until the drug became commercially available.
Participants by arm
| Arm | Count |
|---|---|
| Ziprasidone Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator's opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg. | 331 |
| Total | 331 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 58 |
| Overall Study | Death | 3 |
| Overall Study | Did Not Meet Entrance Criteria | 1 |
| Overall Study | Laboratory Abnormality | 2 |
| Overall Study | Lack of Efficacy | 40 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Protocol Violation | 18 |
| Overall Study | Screened, Not Treated | 13 |
| Overall Study | Withdrawal by Subject | 190 |
| Overall Study | Withdrew During Screening Phase | 8 |
Baseline characteristics
| Characteristic | Ziprasidone |
|---|---|
| Age, Customized 18-44 years | 238 Participants |
| Age, Customized 45-64 years | 93 Participants |
| Sex: Female, Male Female | 138 Participants |
| Sex: Female, Male Male | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 177 / 331 |
| serious Total, serious adverse events | 32 / 331 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
Time frame: Baseline up to 72 months
Population: Safety Analysis Set = All subjects who took at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ziprasidone | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 32 Participants |
| Ziprasidone | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 177 Participants |