Clinical trial NCT01198353: Effectiveness of Ziprasidone for Patients With Schizophrenia
Official title: Study Evaluating Effectiveness of Ziprasidone Using the Overlapped Switching Strategy in Patients With Schizophrenia or Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Ziprasidone
Switch
Metabolic syndrome
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-09-10
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male and female aged 18-55 years treated with risperidone, olanzapine, amisulpride, quetiapine and typical antipsychotics.
* Both in- and outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia or schizoaffective disorder.
* Their primary psychiatric clinician determined that they would benefit from a change in their medications, either because of suboptimal efficacy or because of side effects.

Exclusion Criteria:

* Those who are treated with medications that prolong the QTc interval.
* Those who have any other axis I DSM-IV diagnoses.
* Those who have a history of substance abuse or dependence within 1 month.
* Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results.
* Those who have a past history of hypersensitivity or intolerance to ziprasidone.
* Those who have history of clozapine use within 1 month.
* Those who participated in clinical trials within 1 month before entering the study entry.
* Those who have used depot antipsychotics within one cycle before entering the study.
* Those who are pregnant or are breast feeding.
* Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study.
* The patients unable/unlikely to comprehend/follow the protocol.

Primary outcomes:
measure: A change in the Brief Psychotic Rating Scale (BPRS)
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol)
timeFrame: baseline and 12 weeks
measure: A change in the Body Mass Index (BMI)
timeFrame: baseline and 12 weeks
measure: A change in the Waist-to-hip ratio
timeFrame: baseline and 12 weeks
measure: UKU side effect rating scale - patient (UKU-SERS-Pat)
timeFrame: baseline
measure: UKU side effect rating scale - patient (UKU-SERS-Pat)
timeFrame: 4 weeks
measure: UKU side effect rating scale - patient (UKU-SERS-Pat)
timeFrame: 8 weeks
measure: UKU side effect rating scale - patient (UKU-SERS-Pat)
timeFrame: 12 weeks
measure: A change in the Clinical Global Impression (CGI)
timeFrame: Baseline and 12 weeks
measure: A change in the Global Assessment of Functioning (GAF)
timeFrame: Baseline and 12 weeks
measure: Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
timeFrame: Baseline
measure: Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
timeFrame: 12 weeks
measure: Urinalysis
timeFrame: Baseline
measure: Urinalysis
timeFrame: 12 weeks
measure: Electrocardiogram (ECG)
timeFrame: Baseline
measure: Electrocardiogram (ECG)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Medical Center Ansan Hospital
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Catholic University Our Lady of Mercy Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
Study officials:
affiliation: DEPARTMENT OF PSYCHIATRY SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL
name: Han Yong Jung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.