SchizophreniaPhase 4ESCAPENCT01795183

Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

A Phase 4 study testing AMISULPRIDE in people with Schizophrenia, run by Sanofi at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Primary Objective: To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia Secondary Objective: To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 316 participants
Where: 1 siteChina
Study dates: Nov 2012to Dec 2013
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

Satisfying International Classification of Disease-10 (ICD) diagnostic criteria of schizophrenia;
Positive and Negative Syndrome Scale (PANSS) total score ≥ 60

Who cannot join

Refractory schizophrenia or Patients treated with sufficient clozapine for a minimum period of 6-8 weeks without improvement;
Participation into another clinical trial within the last month;
Patients previously or currently treated with amisulpride;
Patients receiving clozapine within the past 1 month or treated with long-acting formulation of antipsychotic medication within the past 2 months;
Patients receiving electric convulsive therapy or physical therapy within the past 1 month;
Patients with coexisting severe systemic diseases;
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.

China1 site

Sanofi-Aventis Administrative Office
Beijing

Other trials in China

About this study

Official title: The Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia - A Prospective Open-Label Multicenter Study

Primary Objective:

To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia

Secondary Objective:

To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.

Read the detailed description

The study duration by subject will include a 8-week treatment period with 3 follow-up visits.

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
Also called Solian
Pharmaceutical form: tablet Route of administration: oral

Study groups in NCT01795183
Study group	Role	What they receive
Amisulpride	Experimental	Patients are treated with Amisulpride referring to the dosage and usage section in Chinese Solian® PI. Amisulpride dosage is adjusted based on individual response and reaches the sufficiency within 1 week Receives: Drug: AMISULPRIDE

What is being measured

The primary outcome is the main question the study is designed to answer.

Effective percentage (PANSS score reduced rate≥50%)
Measured: Week 8

Secondary outcomes (3)

Early response rate (PANSS score reduced rate: at least 20%)
Measured: week 2
Positive and Negative Syndrome Scale (PANSS)-total score improvement
Measured: Baseline, Week 8
Clinical Global Impression Scale- Improvement (CGI-I)
Measured: Baseline, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Dec 2013

First posted20 Feb 2013 (estimated)
Study startNov 2012
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 316 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01795183
Sponsor's protocol ID: AMISUL06155
Other IDs: U1111-1131-0692
Acronym: ESCAPE
Status last verified: Jan 2015
First submitted: 18 Feb 2013
Last updated: 22 Jan 2015
Results posted: No
Data monitoring committee: Yes

Publications

Liang Y, Yu X. Effectiveness of amisulpride in Chinese patients with predominantly negative symptoms of schizophrenia: a subanalysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Jun 28;13:1703-1712. doi: 10.2147/NDT.S140905. eCollection 2017.
PubMed 28721051
Liang Y, Yu X. The effectiveness and safety of amisulpride in Chinese patients with schizophrenia who switch from risperidone or olanzapine: a subgroup analysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Apr 21;13:1163-1173. doi: 10.2147/NDT.S132363. eCollection 2017.
PubMed 28461752

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
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Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
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Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia - A Prospective Open-Label Multicenter Study
ClinicalTrials.gov ID: NCT01795183
Acronym / sponsor ID: ESCAPE / AMISUL06155
Conditions: Schizophrenia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 316 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 20 Feb 2013 (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 Objective:

To evaluate the effectiveness of amisulpride in Chinese patients with schizophrenia

Secondary Objective:

To evaluate the overall safety of amisulpride in Chinese patients with schizophrenia.

Detailed description

The study duration by subject will include a 8-week treatment period with 3 follow-up visits.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Amisulpride	Experimental	Drug: AMISULPRIDEPatients are treated with Amisulpride referring to the dosage and usage section in Chinese Solian® PI. Amisulpride dosage is adjusted based on individual response and reaches the sufficiency within 1 week

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Satisfying International Classification of Disease-10 (ICD) diagnostic criteria of schizophrenia;
Positive and Negative Syndrome Scale (PANSS) total score ≥ 60

Key exclusion criteria (7 listed)

Refractory schizophrenia or Patients treated with sufficient clozapine for a minimum period of 6-8 weeks without improvement;
Participation into another clinical trial within the last month;
Patients previously or currently treated with amisulpride;
Patients receiving clozapine within the past 1 month or treated with long-acting formulation of antipsychotic medication within the past 2 months;
Patients receiving electric convulsive therapy or physical therapy within the past 1 month;

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
AMISULPRIDEAlso: SolianPharmaceutical form: tablet Route of administration: oral	Drug	Amisulpride

Primary outcome

Effective percentage (PANSS score reduced rate≥50%)
Time frame: Week 8

3 secondary outcomes

Early response rate (PANSS score reduced rate: at least 20%)
Time frame: week 2
Positive and Negative Syndrome Scale (PANSS)-total score improvement
Time frame: Baseline, Week 8
Clinical Global Impression Scale- Improvement (CGI-I)
Time frame: Baseline, Week 8

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 22 Jan 2015.
Derived from this study: PubMed 28721051Liang Y, Yu X. Effectiveness of amisulpride in Chinese patients with predominantly negative symptoms of schizophrenia: a subanalysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Jun 28;13:1703-1712. doi: 10.2147/NDT.S140905. eCollection 2017.
Derived from this study: PubMed 28461752Liang Y, Yu X. The effectiveness and safety of amisulpride in Chinese patients with schizophrenia who switch from risperidone or olanzapine: a subgroup analysis of the ESCAPE study. Neuropsychiatr Dis Treat. 2017 Apr 21;13:1163-1173. doi: 10.2147/NDT.S132363. eCollection 2017.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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.

Clinical Sciences & Operations 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 China.

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 7 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 22 Jan 2015. 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 China. 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?

Effective percentage (PANSS score reduced rate≥50%) (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01795183, which also lists 2 linked publications.

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 22 Jan 2015.