SchizophreniaPhase 4NCT00245674
SOLIACS: Solian Solution in the Acute Setting
A Phase 4 study testing amisulpride in people with Schizophrenia, run by Sanofi at 1 site in Belgium.
Trial summary
During this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode. The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- amisulpride
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2005to 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- schizophrenic in-patients with an acute episode
- aged between 18 and 65 years
- written informed consent
Who cannot join
- pregnancy and breast-feeding
- breast cancer, prolactinoma, pheochromocytoma
- hypersensitivity to amisulpride or one of the other excipients
- contra-indications when using amisulpride as per the SmPC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Solian Solution to Treat Schizophrenic Patients During an Acute Episode
During this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode.
The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of schizophrenia.
- 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.
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.
Secondary outcomes (1)
*analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startJun 2005
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
- 300 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Christian Fassotte, M.D., Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245674
- Sponsor's protocol ID
- PM_L_0055
- Other IDs
- EudraCT # : 2004-004461-15
- Status last verified
- Apr 2008
- First submitted
- 27 Oct 2005
- Last updated
- 10 Apr 2008
- Results posted
- 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
- Solian Solution to Treat Schizophrenic Patients During an Acute Episode
- ClinicalTrials.gov ID
- NCT00245674
- Acronym / sponsor ID
- PM_L_0055
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- First posted
- 28 Oct 2005 (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.
During this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode.
The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- schizophrenic in-patients with an acute episode
- aged between 18 and 65 years
- written informed consent
Key exclusion criteria (4 listed)
- pregnancy and breast-feeding
- breast cancer, prolactinoma, pheochromocytoma
- hypersensitivity to amisulpride or one of the other excipients
- contra-indications when using amisulpride as per the SmPC
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
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.
1 secondary outcome
*analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.
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.
Related trials for Schizophrenia
RecruitingPhase 2
Combination of NMDA-enhancing and Anti-inflammatory Treatments for Schizophrenia
Schizophrenia
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
Schizophrenia
Recruiting
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Patients With Schizophrenia-like Disorders
RecruitingPhase 2
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia
Schizophrenia
Recruiting
Cognitive Remediation Method Using Rhythmic, Vocal and Corporal Musical Learning for Schizophrenia
Schizophrenia Disorders
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.
Dr. Christian Fassotte, M.D. 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 Belgium.
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 4 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 Belgium. 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?
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.. 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.