NCT01795183

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

1.1 years

First QC Date

February 18, 2013

Last Update Submit

January 21, 2015

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Effective percentage (PANSS score reduced rate≥50%)

    Week 8

Secondary Outcomes (3)

  • Early response rate (PANSS score reduced rate: at least 20%)

    week 2

  • Positive and Negative Syndrome Scale (PANSS)-total score improvement

    Baseline, Week 8

  • Clinical Global Impression Scale- Improvement (CGI-I)

    Baseline, Week 8

Study Arms (1)

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

Drug: AMISULPRIDE

Interventions

AMISULPRIDEDRUG

Pharmaceutical form: tablet Route of administration: oral

Also known as: Solian
Amisulpride

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Beijing, China

Location

Related Publications (2)

  • 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.

    PMID: 28721051DERIVED

  • 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.

    PMID: 28461752DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 20, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

CN(1)