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This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy) signals will be checked at every visit during the contracted study period until the maximum study end date, per the protocol, of April 2010.
All patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observational cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ziprasidone | Drug | This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. | Baseline up to Week 8 |
| Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population | CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. | Baseline up to Week 8 |
| Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT | CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. | Baseline up to Week 8 |
| Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP | CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. | Baseline up to Week 8 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement | BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology. |
Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pediatric patients <18 years of age (N=105) were enrolled in error by some sites and were subsequently reported as protocol violations. Given that the objective of this Non-interventional study was to observe the safety and efficacy of Zeldox in real life, the data collected from these participants was included in the safety and efficacy analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziprasidone HCl (Zeldox) | Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ziprasidone HCl (Zeldox) | Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population | CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. | Intent to treat population (ITT): administered at least 1 dose of study treatment at least once a week and observed for at least 1 efficacy assessment. N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits). | Posted | Number | particpants | Baseline up to Week 8 |
|
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An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ziprasidone HCl (Zeldox) | Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA version 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 13.0 | Systematic Assessment |
Per the Statistical Analysis Plan Amendment CGI-S and CGI-I endpoints analyzed as frequency counts (categorical) rather than the planned CGI-S mean change from baseline and CGI-I mean scores (continuous); any additional analyses would be exploratory.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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| Baseline up to Week 8 |
| Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement | DAI-10: a 10-item scale to assess how the attitude of participants with schizophrenia 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 indicates a positive subjective response (compliant); a negative score indicates non-compliance. | Baseline up to Week 8 |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Clinical Global Impression of Severity (CGI-S) status - Intent to treat population (ITT) | Single-item clinician rated scale to rate severity of illness over time. Scores range 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score=more affected. ITT=administered at least 1 dose of study treatment at least once a week and observed for at least 1 efficacy assessment. N=participants with evaluable data at observation. | Number | participants |
|
| CGI-S status - Per protocol population (PP) | Single-item clinician rated scale to rate severity of illness over time. Scores range 1 (normal) to 7 (among the most extremely ill); higher score=more affected. PP= ITT group, study treatment for at least 8 (± 1 week) since enrollment, observed for final efficacy (inpatient visit, phone call). N=participants with evaluable data at observation. | Number | participants |
|
|
|
| Primary | Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population | CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected. | Per Protocol population (PP): participants in ITT group with study treatment for at least 8 (± 1 week) since enrollment and observed for final efficacy (inpatient visit or phone call). N=participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits). | Posted | Number | participants | Baseline up to Week 8 |
|
|
|
| Primary | Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT | CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. | ITT; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits). | Posted | Number | participants | Baseline up to Week 8 |
|
|
|
| Primary | Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP | CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected. | PP; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits). | Posted | Number | participants | Baseline up to Week 8 |
|
|
|
| Other Pre-specified | Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement | BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology. | Safety analysis set: all participants who received at least 1 dose of study treatment. It was recommended to use the optional BPRS tool to gather additional information for the improvement score under usual practice. The optional BPRS tool was not used during the study. | Posted | Baseline up to Week 8 |
|
|
| Other Pre-specified | Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement | DAI-10: a 10-item scale to assess how the attitude of participants with schizophrenia 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 indicates a positive subjective response (compliant); a negative score indicates non-compliance. | Safety analysis set. It was recommended to use the optional DAI-10 tool to gather additional information for the improvement score under usual practice. The optional DAI-10 tool was not used during the study. | Posted | Baseline up to Week 8 |
|
|
| 2 |
| 3,391 |
| 392 |
| 3,391 |
| Open wound | Injury, poisoning and procedural complications | MedDRA version 13.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA version 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version 13.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA version 13.0 | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Hypertonia | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Hypokinesia | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Motor dysfunction | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Blunted affect | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Drug dependence | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Thinking abnormal | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Nocturia | Psychiatric disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Mammary duct ectasia | Reproductive system and breast disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Oculogyric crisis | Eye disorders | MedDRA version 13.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA version 13.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
| Moderately ill |
|
| Markedly ill |
|
| Severely ill |
|
| Among the most extremely ill |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Title | Measurements |
|---|---|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|