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Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone | Drug | 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 |
|
| 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]) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Avignon | 84000 | France | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21796719 | Derived | 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. | |
| 18312045 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziprasidone | Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ziprasidone | Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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. | 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). | Posted | Number | participants | Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF] |
|
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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 | Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia | Psychiatric disorders | WHO-ART | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | WHO-ART | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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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) |
| DOLE Saint YLIE |
| 39108 |
| France |
| Pfizer Investigational Site | Liévin | 62800 | France |
| Pfizer Investigational Site | Lyon | 69373 | France |
| Pfizer Investigational Site | Montfavet | 84143 | France |
| Pfizer Investigational Site | Orvault | 44700 | France |
| Pfizer Investigational Site | Rennes | 35000 | France |
| Pfizer Investigational Site | Saint-Égrève | 38521 | France |
| Pfizer Investigational Site | Saint-Rémy | 70160 | France |
| Pfizer Investigational Site | Strasbourg | 67100 | France |
| Pfizer Investigational Site | Toulon | 83056 | France |
| Pfizer Investigational Site | Toulouse | 31000 | France |
| Pfizer Investigational Site | Toulouse | 31200 | France |
| Pfizer Investigational Site | Versailles | 78000 | France |
| Derived |
| 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. |
| Lack of Efficacy |
|
| Administrative reason/Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | ITT. LOCF. | Posted | Mean | Standard Deviation | score on a scale | Baseline, up to 5 years (End of Study [LOCF]) |
|
|
|
| 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. | ITT | Posted | Number | participants | Baseline, up to 5 years (End of Study) |
|
|
|
| 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. | ITT. n= number of participants with analyzable data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, up to 5 years (End of Study) |
|
|
|
| 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). | ITT. LOCF. | Posted | Number | participants | Baseline, 3 months, 6 months, 1 year, 3 years, 5 years, End of Study [LOCF] |
|
|
|
| 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. | ITT. LOCF. | Posted | Mean | Standard Deviation | score on a scale | Baseline, up to 5 years (End of Study [LOCF]) |
|
|
|
| 13 |
| 43 |
| 36 |
| 43 |
| Anxiety | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Depression | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Drug abuse | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Schizoaffective disorder | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | WHO-ART | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | WHO-ART | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | WHO-ART | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | WHO-ART | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Depression | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Schizoaffective disorder | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Abulia | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Libido increased | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Middle insomnia | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Psychomotor retardation | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Reactive psychosis | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Stress | Psychiatric disorders | WHO-ART | Systematic Assessment |
|
| Headache | Nervous system disorders | WHO-ART | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | WHO-ART | Systematic Assessment |
|
| Parkinsonism | Nervous system disorders | WHO-ART | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | WHO-ART | Systematic Assessment |
|
| Akathisia | Nervous system disorders | WHO-ART | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | WHO-ART | Systematic Assessment |
|
| Somnolence | Nervous system disorders | WHO-ART | Systematic Assessment |
|
| Tremor | Nervous system disorders | WHO-ART | Systematic Assessment |
|
| Weight decreased | Investigations | WHO-ART | Systematic Assessment |
|
| Weight increased | Investigations | WHO-ART | Systematic Assessment |
|
| Influenza | Infections and infestations | WHO-ART | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | WHO-ART | Systematic Assessment |
|
| Bronchitis | Infections and infestations | WHO-ART | Systematic Assessment |
|
| Folliculitis | Infections and infestations | WHO-ART | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | WHO-ART | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | WHO-ART | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | WHO-ART | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | WHO-ART | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | WHO-ART | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | WHO-ART | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | WHO-ART | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | WHO-ART | Systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | WHO-ART | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | WHO-ART | Systematic Assessment |
|
| Hypotension | Vascular disorders | WHO-ART | Systematic Assessment |
|
| Hot flush | Vascular disorders | WHO-ART | Systematic Assessment |
|
| Hypertension | Vascular disorders | WHO-ART | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | WHO-ART | Systematic Assessment |
|
| Drug dispensing error | Injury, poisoning and procedural complications | WHO-ART | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | WHO-ART | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | WHO-ART | Systematic Assessment |
|
| Asthenia | General disorders | WHO-ART | Systematic Assessment |
|
| Chest discomfort | General disorders | WHO-ART | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | WHO-ART | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | WHO-ART | Systematic Assessment |
|
| Myopia | Eye disorders | WHO-ART | Systematic Assessment |
|
| Visual disturbance | Eye disorders | WHO-ART | Systematic Assessment |
|
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | WHO-ART | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | WHO-ART | Systematic Assessment |
|
| Breast cyst | Reproductive system and breast disorders | WHO-ART | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | WHO-ART | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | WHO-ART | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | WHO-ART | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | WHO-ART | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | WHO-ART | Systematic Assessment |
|
| Langerhans' cell granulomatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | WHO-ART | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
| End of study (n=28): much better |
|
| End of study (n=28): slightly better |
|
| End of study (n=28): about the same |
|
| End of study (n=28): slightly worse |
|
| End of study (n=28): much worse |
|
| Title | Measurements |
|---|---|
|
| Baseline (n=43): moderately ill |
|
| Baseline (n=43): markedly ill |
|
| 3 months (n=35): normal, not ill at all |
|
| 3 months (n=35): borderline |
|
| 3 months (n=35): mildly ill |
|
| 3 months (n=35): moderately ill |
|
| 6 months (n=34): normal, not ill at all |
|
| 6 months (n=34): borderline |
|
| 6 months (n=34): mildly ill |
|
| 6 months (n=34): moderately ill |
|
| 1 year (n=27): normal, not ill at all |
|
| 1 year (n=27): borderline |
|
| 1 year (n=27): mildly ill |
|
| 1 year (n=27): moderately ill |
|
| 3 years (n=10): normal, not ill at all |
|
| 3 years (n=10): borderline |
|
| 3 years (n=10): mildly ill |
|
| 3 years (n=10): moderately ill |
|
| 5 years (n=7): normal, not ill at all |
|
| 5 years (n=7): borderline |
|
| 5 years (n=7): mildly ill |
|
| End of Study [LOCF] (n=43): normal, not ill at all |
|
| End of Study [LOCF] (n=43): borderline |
|
| End of Study [LOCF] (n=43): mildly ill |
|
| End of Study [LOCF] (n=43): moderately ill |
|
| End of Study [LOCF] (n=43):markedly ill |
|
| End of Study [LOCF] (n=43): severely ill |
|