A Phase 4 interventional study of ziprasidone in Schizophrenia and Schizoaffective Disorder, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 40 sites in 6 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-03-29.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment
The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 255 is above the median of 70 across 2,872 interventional 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.
Exclusion Criteria:
atypical antipsychotic for the treatment of schizophrenia
Drug: ziprasidone
Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
Also known as: Geodon, Zeldox
Change From Baseline in Weight at Week 16
Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
Total cholesterol value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
HbAlc value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Change From Baseline in Fasting Glucose at Week 16
Fasting glucose value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Change From Baseline in Fasting Insulin at Week 16
Fasting insulin value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Change From Baseline in Waist and Hip Circumference at Week 16
Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.
Time frame: Baseline, Week 16
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Time frame: Week 16, Week 16 LOCF
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
| Milestone | Ziprasidone |
|---|---|
| Started | 241 |
| Completed | 100 |
| Not completed | 141 |
| Withdrew: Death | 1 |
| Withdrew: Adverse event | 39 |
| Withdrew: Laboratory abnormality | 4 |
| Withdrew: Lack of efficacy | 13 |
| Withdrew: Other | 33 |
| Withdrew: Lost to follow-up | 21 |
| Withdrew: Withdrawal by subject | 30 |
Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
| kilogram | Ziprasidone |
|---|---|
| Week 16 (n=133) | -1.09 ± 3.918 |
| Week 16 LOCF (n=231) | -0.73 ± 3.725 |
Total cholesterol value: Change = value at Week 16 minus value at Baseline.
| milligram (mg)/deciliter (dL) | Ziprasidone |
|---|---|
| Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16 | -3.0 ± 31.14 |
HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.
| mg/dL | Ziprasidone |
|---|---|
| HDL (n=128) | -0.2 ± 9.32 |
| LDL (n=123) | -2.5 ± 25.66 |
| Triglycerides (n=128) | -1.6 ± 84.58 |
HbAlc value: Change = value at Week 16 minus value at Baseline.
| percent | Ziprasidone |
|---|---|
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16 | 0.1 ± 0.44 |
Fasting glucose value: Change = value at Week 16 minus value at Baseline.
| mg/dL | Ziprasidone |
|---|---|
| Change From Baseline in Fasting Glucose at Week 16 | 3.0 ± 17.84 |
Fasting insulin value: Change = value at Week 16 minus value at Baseline.
| microinternational (mciu)/milliliter(mL) | Ziprasidone |
|---|---|
| Change From Baseline in Fasting Insulin at Week 16 | 134.8 ± 851.28 |
Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.
| centimeter | Ziprasidone |
|---|---|
| Waist (n=132) | -2.9 ± 17.53 |
| Hip (n=131) | -3.0 ± 18.21 |
AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.
| scores on a scale | Ziprasidone |
|---|---|
| AIMS Total Score | 0.05 ± 2.251 |
| AIMS Global Severity Score | 0.03 ± 0.472 |
| AIMS Global Incapacitation Score | 0.01 ± 0.383 |
PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.
| scores on a scale | Ziprasidone |
|---|---|
| Total Score, Week 16 (n=144) | -10.22 ± 15.027 |
| Total Score, Week 16 LOCF (n=231) | -6.61 ± 15.306 |
| Positive Subscale Score, Week 16 (n=144) | -3.30 ± 4.658 |
| Positive Subscale Score, Week 16 LOCF (n=231) | -2.43 ± 4.634 |
| Negative Subscale Score, Week 16 (n=144) | -1.67 ± 4.147 |
| Negative Subscale Score, Week 16 LOCF (n=231) | -0.92 ± 4.373 |
The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
| scores on a scale | Ziprasidone |
|---|---|
| Week 16 (n=135) | -0.76 ± 0.868 |
| Week 16 LOCF (n=231) | -0.47 ± 0.848 |
The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).
| scores on a scale | Ziprasidone |
|---|---|
| Week 16 (n=135) | 2.7 ± 1.05 |
| Week 16 LOCF (n=231) | 3.2 ± 1.22 |
The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
| scores on a scale | Ziprasidone |
|---|---|
| Week 16 (n=144) | -2.55 ± 4.364 |
| Week 16 LOCF (n=231) | -1.58 ± 4.526 |
The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
| scores on a scale | Ziprasidone |
|---|---|
| Total Score, Week 16 (n=137) | -4.61 ± 7.981 |
| Total Score, Week 16 LOCF (n=169) | -4.21 ± 8.961 |
| Global Rating, Week 16 (n=137) | -1.02 ± 1.708 |
| Global Rating, Week 16 LOCF (n=169) | -0.88 ± 1.643 |
GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
| scores on a scale | Ziprasidone |
|---|---|
| Week 16 (n=145) | 7.88 ± 11.029 |
| Week 16 LOCF (n=230) | 5.27 ± 10.626 |
The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
| scores on a scale | Ziprasidone |
|---|---|
| Effectiveness, Week 16 (n=178) | 10.49 ± 30.662 |
| Effectiveness, Week 16 LOCF (n=178) | 10.49 ± 30.662 |
| Side Effect, Week 16 (n=167) | 18.49 ± 42.883 |
| Side Effect, Week 16 LOCF (n=167) | 18.49 ± 42.883 |
| Convenience, Week 16 (n=180) | 6.45 ± 23.630 |
| Convenience, Week 16 LOCF (n=180) | 6.45 ± 23.630 |
| Global Satisfaction, Week 16 (n=179) | 15.32 ± 36.304 |
| Global Satisfaction, Week 16 LOCF (n=179) | 15.32 ± 36.304 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ziprasidone | — | 22/241 (9.1%) | 124/241 (51.5%) |
| Event | Ziprasidone |
|---|---|
| Schizoaffective disorderPsychiatric disorders | 4/241 |
| SchizophreniaPsychiatric disorders | 4/241 |
| Psychotic disorderPsychiatric disorders | 3/241 |
| DepressionPsychiatric disorders | 2/241 |
| Suicidal ideationPsychiatric disorders | 2/241 |
| Suicide attemptPsychiatric disorders | 2/241 |
| AnaemiaBlood and lymphatic system disorders | 1/241 |
| Lung infectionInfections and infestations | 1/241 |
| DystoniaNervous system disorders | 1/241 |
| AggressionPsychiatric disorders | 1/241 |
| Event | Ziprasidone |
|---|---|
| InsomniaPsychiatric disorders | 46/241 |
| SomnolenceNervous system disorders | 35/241 |
| NauseaGastrointestinal disorders | 28/241 |
| HeadacheNervous system disorders | 24/241 |
| SedationNervous system disorders | 17/241 |
| VomitingGastrointestinal disorders | 16/241 |
| AkathisiaNervous system disorders | 15/241 |
| AnxietyPsychiatric disorders | 15/241 |
| DizzinessNervous system disorders | 13/241 |
| Decreased appetiteMetabolism and nutrition disorders | 12/241 |
| Age, Customized(participants) | Ziprasidone |
|---|---|
| < 18 years | 0 |
| 18 to 44 years | 140 |
| 45 to 64 years | 101 |
| > = 65 years | 0 |
| Sex: Female, Male(Participants) | Ziprasidone |
|---|---|
| Female | 111 |
| Male | 130 |
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.