First Episode PsychosisPhase 4NCT01157559
Efficacy and Safety With Ziprasidone in First-episode Psychosis
A Phase 4 study testing Ziprasidone in people with First Episode Psychosis, run by Chonbuk National University Hospital at 3 sites in South Korea.
Trial summary
The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis. Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- First Episode Psychosis
- What is being tested?
- Ziprasidone
- How many people
- 27 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Start not givento May 2010
- 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 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder
Who cannot join
- Patients with previously prescribed antipsychotic medication in 2 weeks or more
- patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Department of Psychiatry, Chonbuk national University Hospital
Jeonju
Heo psychiatric Hospital
Jeonju
Jeonju Jesus Hospital
Jeonju
About this study
Official title: Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study
The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.
- Conditions
- First Episode Psychosis
- Being tested
- Ziprasidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiprasidoneDrug
8 week prospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
Measured: week 1
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
Measured: week 2
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
Measured: week 4
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF
Measured: week 6
Symptoms assessment by objective rating scales
PANSS total score, SANS, clinical global impression scale, GAF, DAS-S
Measured: week 8
Secondary outcomes (2)
Assessment of adverse events by objective rating scales and self report scales
Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale
Measured: one-month
Assessment of adverse events by objective rating scales and self report scales
Simpson and Angus rating scale, Barnes Akathisia rating scale and Abnormal Involuntary Movement Scale
Measured: two-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Primary completionJun 2008
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Episode PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157559
- Sponsor's protocol ID
- 2006-Zeldox in FEP
- Status last verified
- Jan 2007
- First submitted
- 30 Jun 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study
- ClinicalTrials.gov ID
- NCT01157559
- Acronym / sponsor ID
- 2006-Zeldox in FEP
- Conditions
- First Episode Psychosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Primary completion
- Jun 2008 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder
Key exclusion criteria (2 listed)
- Patients with previously prescribed antipsychotic medication in 2 weeks or more
- patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ziprasidone8 week prospective study | Drug | – |
Primary outcome
Symptoms assessment by objective rating scales
Time frame: week 1
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
Time frame: week 2
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
Time frame: week 4
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
Time frame: week 6
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
Time frame: week 8
PANSS total score, SANS, clinical global impression scale, GAF, DAS-S
2 secondary outcomes
Assessment of adverse events by objective rating scales and self report scales
Time frame: one-month
Assessment of adverse events by objective rating scales and self report scales
Time frame: two-month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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First-Episode Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ziprasidone in people with First Episode Psychosis, run by Chonbuk National University Hospital at 3 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 1 inclusion and 2 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 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Symptoms assessment by objective rating scales (time frame: week 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2010.