Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia (ESCAPE)
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ClinicalTrials.gov Identifier: NCT01795183 |
Recruitment Status :
Completed
First Posted : February 20, 2013
Last Update Posted : January 22, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: AMISULPRIDE | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 316 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia - A Prospective Open-Label Multicenter Study |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Amisulpride
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
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Drug: AMISULPRIDE
Pharmaceutical form: tablet Route of administration: oral
Other Name: Solian |
- Effective percentage (PANSS score reduced rate≥50%) [ Time Frame: Week 8 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
- Satisfying International Classification of Disease-10 (ICD) diagnostic criteria of schizophrenia;
- Positive and Negative Syndrome Scale (PANSS) total score ≥ 60
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795183
China | |
Sanofi-Aventis Administrative Office | |
Beijing, China |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01795183 |
Other Study ID Numbers: |
AMISUL06155 U1111-1131-0692 ( Other Identifier: UTN ) |
First Posted: | February 20, 2013 Key Record Dates |
Last Update Posted: | January 22, 2015 |
Last Verified: | January 2015 |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Amisulpride Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents |