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SchizophreniaPhase 4NCT01198353

Effectiveness of Ziprasidone for Patients With Schizophrenia

A Phase 4 study testing Ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by Soonchunhyang University Hospital at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia, Schizoaffective Disorder
What is being tested?
Ziprasidone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
6 sitesSouth Korea
Study dates
Sep 2010to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • Korea University Medical Center Ansan Hospital

    Ansan, Gyeonggi-do, 425-707

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, 420-767

  • Inha University Hospital

    Incheon, 400-700

  • Catholic University Our Lady of Mercy Hospital

    Incheon, 403-720

  • Korea University Medical Center Guro Hospital

    Seoul, 152-703

  • Kangnam Sacred Heart Hospital

    Seoul, 431-070

Other trials in South Korea

About this study

Official title: Study Evaluating Effectiveness of Ziprasidone Using the Overlapped Switching Strategy in Patients With Schizophrenia or Schizoaffective Disorder

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.

Read the 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.

Being tested
Ziprasidone
Keywords
Schizophrenia, Schizoaffective Disorder, Ziprasidone, Switch, Metabolic syndrome
Medical subject headings
Schizophrenia, Psychotic Disorders, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZiprasidoneDrug

    Also called Zeldox

    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.

Study groups in NCT01198353
Study groupRoleWhat they receive
ZiprasidoneExperimentalDuring 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.
Receives: Drug: Ziprasidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A change in the Brief Psychotic Rating Scale (BPRS)

    Measured: baseline and 12 weeks

Secondary outcomes (15)

  1. A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol)

    Measured: baseline and 12 weeks

  2. A change in the Body Mass Index (BMI)

    Measured: baseline and 12 weeks

  3. A change in the Waist-to-hip ratio

    Measured: baseline and 12 weeks

  4. UKU side effect rating scale - patient (UKU-SERS-Pat)

    Measured: baseline

  5. UKU side effect rating scale - patient (UKU-SERS-Pat)

    Measured: 4 weeks

  6. UKU side effect rating scale - patient (UKU-SERS-Pat)

    Measured: 8 weeks

  7. UKU side effect rating scale - patient (UKU-SERS-Pat)

    Measured: 12 weeks

  8. A change in the Clinical Global Impression (CGI)

    Measured: Baseline and 12 weeks

  9. A change in the Global Assessment of Functioning (GAF)

    Measured: Baseline and 12 weeks

  10. Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein

    Measured: Baseline

  11. Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein

    Measured: 12 weeks

  12. Urinalysis

    Measured: Baseline

  13. Urinalysis

    Measured: 12 weeks

  14. Electrocardiogram (ECG)

    Measured: Baseline

  15. Electrocardiogram (ECG)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJun 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01198353
Sponsor's protocol ID
IG-KOR-017-2009
Status last verified
Nov 2014
First submitted
8 Sep 2010
Last updated
19 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17140769

  • 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.

    PubMed 17637612

  • 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.

    PubMed 20470848

  • 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.

    PubMed 17129654

  • 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.

    PubMed 19531959

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ziprasidone in people with Schizophrenia and Schizoaffective Disorder, run by Soonchunhyang University Hospital at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A change in the Brief Psychotic Rating Scale (BPRS) (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01198353, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.

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