SchizophreniaPhase 4ASAPNCT00436371
Amisulpride in Schizophrenic Acute Phase Patients
A Phase 4 study testing Amisulpride in people with Schizophrenia, run by Sanofi at 1 site in Hong Kong.
Trial summary
To collect the safety and response of using Amisulpride in acute schizophrenic patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Amisulpride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2005to Nov 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode
Who cannot join
- Patients previously treated with amisulpride
- Patients have comorbidity which may interfere with the treatment or follow-up
- Patients currently taking depot antipsychotics (at least 30 days washout period is needed)
- Patients currently/ or recently (< 3 months) withdrawn from drug or alcohol abuse
- Pregnant or lactation
- 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: The Use of Amisulpride in Schizophrenic Acute Phase Patients.
To collect the safety and response of using Amisulpride in acute 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
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Amisulpride 400-800mg per day on a twice-a-day regimen Receives: Drug: Amisulpride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: all across the study
Secondary outcomes (4)
Clinical Global Impressions
Measured: All accross the study
Patient compliance
Measured: all across the study
Percentage of patient completing treatment
Measured: all across the study
Changes in body weight
Measured: At baseline and day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startMay 2005
- Primary completionNov 2006
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
- 50 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elaine Tang, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436371
- Sponsor's protocol ID
- L_9517
- Acronym
- ASAP
- Status last verified
- Sep 2008
- First submitted
- 15 Feb 2007
- Last updated
- 5 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Amisulpride in Schizophrenic Acute Phase Patients.
- ClinicalTrials.gov ID
- NCT00436371
- Acronym / sponsor ID
- ASAP / L_9517
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Nov 2006 (actual)
- First posted
- 19 Feb 2007 (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.
To collect the safety and response of using Amisulpride in acute schizophrenic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AmisulprideAmisulpride 400-800mg per day on a twice-a-day regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode
Key exclusion criteria (6 listed)
- Patients previously treated with amisulpride
- Patients have comorbidity which may interfere with the treatment or follow-up
- Patients currently taking depot antipsychotics (at least 30 days washout period is needed)
- Patients currently/ or recently (< 3 months) withdrawn from drug or alcohol abuse
- Pregnant or lactation
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 |
|---|---|---|
| AmisulprideOral tablets | Drug | 1 |
Primary outcome
Adverse events
Time frame: all across the study
4 secondary outcomes
Clinical Global Impressions
Time frame: All accross the study
Patient compliance
Time frame: all across the study
Percentage of patient completing treatment
Time frame: all across the study
Changes in body weight
Time frame: At baseline and day 84
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 5 Sep 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.
Elaine Tang 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 Hong Kong.
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 6 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 5 Sep 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 Hong Kong. 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?
Adverse events (time frame: all across the study). 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 5 Sep 2008.