SchizophreniaPhase 4NCT00352339
The New Strategy for Pharmacological Treatment in People With Schizophrenia
A Phase 4 study testing Rispridoen and Aripiprazole, Risperidne and Abilify in people with Schizophrenia, run by Inje University at 2 sites in South Korea.
Trial summary
Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate the same efficacy as compared to risperidone continuation treatment in the treatment of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Rispridoen and Aripiprazole, Risperidne and Abilify
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Aug 2006to Dec 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia, DSM-IV
- Acute phase
Who cannot join
- Refractory Schizophrenia
- Substance Abuse
- High risk for suicide
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Dongrae Hospital
Busan, 609-370
Yung-Soo Seo, MD.PhD, 82-51-508-0011, npsys@hanmail.net
Young-Soo Seo, MD.PhD
- Recruiting
Dongseo Hospital
Masan, 630-856
Do-Un Jung, MD, 82-016-579-2985, cgabriel@chol.com
Do-Un Jung, MD
About this study
Official title: Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia
Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate the same efficacy as compared to risperidone continuation treatment in the treatment of schizophrenia.
Read the detailed description
It has been thought that D2 Blocking agent is necessary in acute as well as maintenance phase of pharmacological treatment of patients with schizophrenia. However, this classical strategy produces long term adverse events of drug such as TD, osteoporosis and some metabolic syndrome. To overcome these adverse events, new strategy for pharmacological treatment is needed.
- Conditions
- Schizophrenia
- Being tested
- Rispridoen and Aripiprazole, Risperidne, Abilify
- Keywords
- Schizophrenia, Switching, Early stage, Risperidone, Aripirazole
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rispridoen and AripiprazoleDrug
Start with risperidone and switch it to aripiprazole. Flexible dose
RisperidneDrug
Start with risperidne and keep it through the end of study. Risperidne:flexible dose
AbilifyDrug
Also called abilify is a generic name of aripiprazole
Start with abilify and keep it through the end of study
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Experimental | switching group (from risperidone to aripiprazole) Receives: Drug: Rispridoen and Aripiprazole |
| Risperidone | Active comparator | Start with risperidone and keep it through the end of study Receives: Drug: Risperidne |
| Abilify | Active comparator | Start with aripiprazole and keep it through the end of study Receives: Drug: Abilify |
What is being measured
The primary outcome is the main question the study is designed to answer.
SANS(Scale for the Assessment of Negative Symptoms)
Measured: 12 weeks
Secondary outcomes (3)
SARS(Simpson-Angus Rating Scale)
Measured: 12 weeks
Drug Attitude Inventory
Measured: 12 weeks
Side effect checklist
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Investigators
- Joo-Cheol Shim, MD,PhD, Principal investigator, Clinical Trial Center, Paik hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352339
- Sponsor's protocol ID
- Aripiprazole study 2006
- Status last verified
- Aug 2009
- First submitted
- 13 Jul 2006
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia
- ClinicalTrials.gov ID
- NCT00352339
- Acronym / sponsor ID
- Aripiprazole study 2006
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Switching, Early stage, Risperidone, Aripirazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 14 Jul 2006 (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.
Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate the same efficacy as compared to risperidone continuation treatment in the treatment of schizophrenia.
Detailed description
It has been thought that D2 Blocking agent is necessary in acute as well as maintenance phase of pharmacological treatment of patients with schizophrenia. However, this classical strategy produces long term adverse events of drug such as TD, osteoporosis and some metabolic syndrome. To overcome these adverse events, new strategy for pharmacological treatment is needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Experimental | Drug: Rispridoen and Aripiprazoleswitching group (from risperidone to aripiprazole) |
| Risperidone | Active comparator | Drug: RisperidneStart with risperidone and keep it through the end of study |
| Abilify | Active comparator | Drug: AbilifyStart with aripiprazole and keep it through the end of study |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Schizophrenia, DSM-IV
- Acute phase
Key exclusion criteria (3 listed)
- Refractory Schizophrenia
- Substance Abuse
- High risk for suicide
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 |
|---|---|---|
| Rispridoen and AripiprazoleStart with risperidone and switch it to aripiprazole. Flexible dose | Drug | Aripiprazole |
| RisperidneStart with risperidne and keep it through the end of study. Risperidne:flexible dose | Drug | Risperidone |
| AbilifyAlso: abilify is a generic name of aripiprazoleStart with abilify and keep it through the end of study | Drug | Abilify |
Primary outcome
SANS(Scale for the Assessment of Negative Symptoms)
Time frame: 12 weeks
3 secondary outcomes
SARS(Simpson-Angus Rating Scale)
Time frame: 12 weeks
Drug Attitude Inventory
Time frame: 12 weeks
Side effect checklist
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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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.
Joo-Cheol Shim, MD,PhD principal investigator
Clinical Trial Center, Paik hospital
2 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 Rispridoen and Aripiprazole, Risperidne and Abilify in people with Schizophrenia, run by Inje University at 2 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun-A Lee, MS (82-51-890-8955, euna066@nate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SANS(Scale for the Assessment of Negative Symptoms) (time frame: 12 weeks). 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 6 Aug 2009.