An observational study in Bipolar Disorder and Schizophrenia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Observational
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 3,391 is above the median of 178 across 491 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Drug: ziprasidone
This is a non-interventional, pharmacovigilance study, therefore patients are on ziprasidone as prescribed by their doctor.
Also known as: Geodon, Zeldox
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to Week 8
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.
Time frame: 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.
Time frame: Baseline up to Week 8
| Milestone | Ziprasidone HCl (Zeldox) |
|---|---|
| Started | 3391 |
| Completed | 3018 |
| Not completed | 373 |
| Withdrew: Adverse event | 64 |
| Withdrew: Other | 309 |
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.
| particpants | Ziprasidone HCl (Zeldox) |
|---|---|
| Normal, not ill at all | 190 |
| Borderline mentally ill | 1125 |
| Mildly ill | 1325 |
| Moderately ill | 506 |
| Markedly ill | 156 |
| Severely ill | 46 |
| Among the most extremely ill | 3 |
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.
| participants | Ziprasidone HCl (Zeldox) |
|---|---|
| Normal, not ill at all | 130 |
| Borderline mentally ill | 815 |
| Mildly ill | 889 |
| Moderately ill | 320 |
| Markedly ill | 77 |
| Severely ill | 21 |
| Among the most extremely ill | 2 |
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.
| participants | Ziprasidone HCl (Zeldox) |
|---|---|
| Very much improved | 368 |
| Much improved | 1026 |
| Minimally improved | 1361 |
| No change | 512 |
| Minimally worse | 71 |
| Much worse | 13 |
| Very much worse | 0 |
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.
| participants | Ziprasidone HCl (Zeldox) |
|---|---|
| Very much improved | 271 |
| Much improved | 751 |
| Minimally improved | 889 |
| No change | 299 |
| Minimally worse | 36 |
| Much worse | 8 |
| Very much worse | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ziprasidone HCl (Zeldox) | — | 2/3,391 (0.1%) | 392/3,391 (11.6%) |
| Event | Ziprasidone HCl (Zeldox) |
|---|---|
| AstheniaGeneral disorders | 1/3391 |
| Open woundInjury, poisoning and procedural complications | 1/3391 |
| Electrocardiogram QT prolongedInvestigations | 1/3391 |
| DizzinessNervous system disorders | 1/3391 |
| Psychotic disorderPsychiatric disorders | 1/3391 |
| Suicide attemptPsychiatric disorders | 1/3391 |
| Event | Ziprasidone HCl (Zeldox) |
|---|---|
| AkathisiaNervous system disorders | 80/3391 |
| SomnolenceNervous system disorders | 72/3391 |
| Extrapyramidal disorderNervous system disorders | 68/3391 |
| InsomniaPsychiatric disorders | 58/3391 |
| AnxietyPsychiatric disorders | 39/3391 |
| AstheniaGeneral disorders | 33/3391 |
| DizzinessNervous system disorders | 26/3391 |
| NauseaGastrointestinal disorders | 24/3391 |
| HeadacheNervous system disorders | 20/3391 |
| DystoniaNervous system disorders | 14/3391 |
| Age, Customized(participants) | Ziprasidone HCl (Zeldox) |
|---|---|
| <18 years | 105 |
| Between 18 and 44 years | 2377 |
| Between 45 and 64 years | 723 |
| >=65 years | 186 |
| Sex: Female, Male(Participants) | Ziprasidone HCl (Zeldox) |
|---|---|
| Female | 1926 |
| Male | 1465 |
| Clinical Global Impression of Severity (CGI-S) status - Intent to treat population (ITT)(participants) | Ziprasidone HCl (Zeldox) |
|---|---|
| Normal, not ill at all | 6 |
| Borderline mentally ill | 110 |
| Mildly ill | 669 |
| Moderately ill | 1264 |
| Markedly ill | 808 |
| Severely ill | 440 |
| Among the most extremely ill | 54 |
| CGI-S status - Per protocol population (PP)(participants) | Ziprasidone HCl (Zeldox) |
|---|---|
| Normal, not ill at all | 3 |
| Borderline mentally ill | 68 |
| Mildly ill | 454 |
| Moderately ill | 877 |
| Markedly ill | 547 |
| Severely ill | 266 |
| Among the most extremely ill | 39 |
No study locations are listed for this record.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.