SchizophreniaPhase 4NCT00331981
Amisulpride in Schizophrenic Patients
A Phase 4 study testing Amisulpride in people with Schizophrenia, run by Sanofi at 1 site in South Korea.
Trial summary
Primary purpose: To find out how effective is long term treatment with amisulpride on the positive and negative symptoms in schizophrenic patients To find out how safe is long term treatment with amisulpride in schizophrenic patients Secondary purpose: To find out how effective is long term treatment with amisulpride… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Amisulpride
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2004to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as schizophrenia or schizophrenic disorder according to DSM-IV
- Patients who need new anti-psychotic drugs or need to change the medication due to aggravations of symptoms or recurrence
Who cannot join
- Patients with positive symptoms in whom the disorder does not correspond to schizophrenic criteria. (e.g, schizoaffective disorder)
- Patients hypersensitive to the active ingredient or to other ingredients of the study drug
- Prolactin-dependant tumors, pituitary gland prolactinomas and breast cancer
- Pheochromocytoma or Parkinson's disease
- Pregnancy or breast feeding
- Current or recently withdrawn from drug abuse or alcoholism
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- Chronic renal failure and other internal or surgical disease which physician decides will be worsened by trial medication or that will affect the metabolism or effects of the trial medication
- Patients with previous histories and clinical improvement was not seen in spite of treatment with 2 anti-psychotics for over 8 weeks
- Slow heart rate of <55bpm, low blood potassium level, congenital prolongation of the QT interval
- Current treatment with a drug likely to cause markedly slow heart rate(<55bpm), low blood potassium level, slowing of intercardiac condition or prolongation of the QT interval
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients
Primary purpose:
- To find out how effective is long term treatment with amisulpride on the positive and negative symptoms in schizophrenic patients
- To find out how safe is long term treatment with amisulpride in schizophrenic patients
Secondary purpose:
- To find out how effective is long term treatment with amisulpride on the quality of life in schizophrenic patients
- To find out how effective is long term treatment with amisulpride on the cognitive function in schizophrenic patients
- Conditions
- Schizophrenia
- Being tested
- Amisulpride
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmisulprideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS scores
Measured: at every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startFeb 2004
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 138 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Won Sik Lee, MD, PhD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331981
- Sponsor's protocol ID
- L_8968
- Status last verified
- Apr 2008
- First submitted
- 30 May 2006
- Last updated
- 10 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00331981
- Acronym / sponsor ID
- L_8968
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- First posted
- 31 May 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.
Primary purpose:
- To find out how effective is long term treatment with amisulpride on the positive and negative symptoms in schizophrenic patients
- To find out how safe is long term treatment with amisulpride in schizophrenic patients
Secondary purpose:
- To find out how effective is long term treatment with amisulpride on the quality of life in schizophrenic patients
- To find out how effective is long term treatment with amisulpride on the cognitive function in schizophrenic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed as schizophrenia or schizophrenic disorder according to DSM-IV
- Patients who need new anti-psychotic drugs or need to change the medication due to aggravations of symptoms or recurrence
Key exclusion criteria (11 listed)
- Patients with positive symptoms in whom the disorder does not correspond to schizophrenic criteria. (e.g, schizoaffective disorder)
- Patients hypersensitive to the active ingredient or to other ingredients of the study drug
- Prolactin-dependant tumors, pituitary gland prolactinomas and breast cancer
- Pheochromocytoma or Parkinson's disease
- Pregnancy or breast feeding
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 |
|---|---|---|
| Amisulpride | Drug | – |
Primary outcome
PANSS scores
Time frame: at every visit
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 10 Apr 2008.
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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.
Won Sik Lee, MD, PhD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amisulpride in people with Schizophrenia, run by Sanofi at 1 site 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 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 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
PANSS scores (time frame: at every visit). 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 10 Apr 2008; AzTrials last refreshed its copy on 27 Oct 2026.