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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study is designed with the aim to evaluate the clinical effect of the overlapped switching to ziprasidone as well as the efficacy and safe metabolic profile of ziprasidone.
Patients with schizophrenia or schizoaffective disorder were recruited in this 12-week, multicenter, non-comparative, open-label trial. Prior antipsychotics were allowed to be maintained for up to 4 weeks during the titration of ziprasidone. Efficacy was primarily measured using the 18-item Brief Psychotic Rating Scale (BPRS) at baseline, 4 weeks, 8 weeks, and 12 weeks. Efficacy was secondarily measured by the Clinical Global Impression - Severity (CGI-S) scale and the Global Assessment of Functioning (GAF) scale at each visit. Regarding the metabolic effects of switching to ziprasidone, weight, body mass index (BMI), waist-to-hip ratio (WHR), and lipid profile-including triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol levels-were measured at each follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ziprasidone | Experimental | During the 12-week study period, patients were prescribed ziprasidone at 20 to 160 mg/day flexibly based on their effectiveness and tolerability. Fifty to one hundred percent of the past antipsychotic dose was maintained in the first week; during next 3 weeks, flexible dosing of 0-100% was used; then, ziprasidone was discontinued. This study included four visits: baseline, week 4, week 8, and week 12. Concomitant benzodiazepines (oral formula or injection) were allowed up to a dose of 4 mg of lorazepam-equivalents per day for anxiety and agitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone | Drug | 100% of the past antipsychotic dose will be maintained in week 1, using flexible dosing of 0-100% during next 3 weeks and then discontinued. Ziprasidone will be maintained with flexible dosing of 40-160mg/day during the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| A change in the Brief Psychotic Rating Scale (BPRS) | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol) | baseline and 12 weeks | |
| A change in the Body Mass Index (BMI) | baseline and 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han Yong Jung, MD, PhD | DEPARTMENT OF PSYCHIATRY SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Medical Center Ansan Hospital | Ansan | Gyeonggi-do | 425-707 | South Korea | ||
| Soonchunhyang University Bucheon Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17140769 | Background | Kudla D, Lambert M, Domin S, Kasper S, Naber D. Effectiveness, tolerability, and safety of ziprasidone in patients with schizophrenia or schizoaffective disorder: results of a multi-centre observational trial. Eur Psychiatry. 2007 Apr;22(3):195-202. doi: 10.1016/j.eurpsy.2006.06.004. Epub 2006 Nov 29. | |
| 17637612 | Background |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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|
| A change in the Waist-to-hip ratio |
| baseline and 12 weeks |
| UKU side effect rating scale - patient (UKU-SERS-Pat) | baseline |
| UKU side effect rating scale - patient (UKU-SERS-Pat) | 4 weeks |
| UKU side effect rating scale - patient (UKU-SERS-Pat) | 8 weeks |
| UKU side effect rating scale - patient (UKU-SERS-Pat) | 12 weeks |
| A change in the Clinical Global Impression (CGI) | Baseline and 12 weeks |
| A change in the Global Assessment of Functioning (GAF) | Baseline and 12 weeks |
| Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein | Baseline |
| Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein | 12 weeks |
| Urinalysis | Baseline |
| Urinalysis | 12 weeks |
| Electrocardiogram (ECG) | Baseline |
| Electrocardiogram (ECG) | 12 weeks |
| Bucheon-si |
| 420-767 |
| South Korea |
| Inha University Hospital | Incheon | 400-700 | South Korea |
| Catholic University Our Lady of Mercy Hospital | Incheon | 403-720 | South Korea |
| Korea University Medical Center Guro Hospital | Seoul | 152-703 | South Korea |
| Kangnam Sacred Heart Hospital | Seoul | 431-070 | South Korea |
| Weiden PJ, Newcomer JW, Loebel AD, Yang R, Lebovitz HE. Long-term changes in weight and plasma lipids during maintenance treatment with ziprasidone. Neuropsychopharmacology. 2008 Apr;33(5):985-94. doi: 10.1038/sj.npp.1301482. Epub 2007 Jul 18. |
| 20470848 | Background | Stip E, Zhornitsky S, Potvin S, Tourjman V. Switching from conventional antipsychotics to ziprasidone: a randomized, open-label comparison of regimen strategies. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Aug 16;34(6):997-1000. doi: 10.1016/j.pnpbp.2010.05.010. Epub 2010 May 12. |
| 17129654 | Background | Montes JM, Rodriguez JL, Balbo E, Sopelana P, Martin E, Soto JA, Delgado JF, Diez T, Villardaga I. Improvement in antipsychotic-related metabolic disturbances in patients with schizophrenia switched to ziprasidone. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Mar 30;31(2):383-8. doi: 10.1016/j.pnpbp.2006.10.002. Epub 2006 Nov 28. |
| 19531959 | Background | Alptekin K, Hafez J, Brook S, Akkaya C, Tzebelikos E, Ucok A, El Tallawy H, Danaci AE, Lowe W, Karayal ON. Efficacy and tolerability of switching to ziprasidone from olanzapine, risperidone or haloperidol: an international, multicenter study. Int Clin Psychopharmacol. 2009 Sep;24(5):229-38. doi: 10.1097/YIC.0b013e32832c2624. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |