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Amisulpride in Schizophrenic Patients

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Amisulpride
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed as schizophrenia or schizophrenic disorder according to DSM-IV Patients who need new anti-psychotic drugs or need to change the medication due to aggravations of symptoms or recurrence Exclusion Criteria: Patients with positive symptoms in whom the disorder does not correspond to schizophrenic criteria. (e.g, schizoaffective disorder) Patients hypersensitive to the active ingredient or to other ingredients of the study drug Prolactin-dependant tumors, pituitary gland prolactinomas and breast cancer Pheochromocytoma or Parkinson's disease Pregnancy or breast feeding Current or recently withdrawn from drug abuse or alcoholism Chronic renal failure and other internal or surgical disease which physician decides will be worsened by trial medication or that will affect the metabolism or effects of the trial medication Patients with previous histories and clinical improvement was not seen in spite of treatment with 2 anti-psychotics for over 8 weeks Slow heart rate of <55bpm, low blood potassium level, congenital prolongation of the QT interval Current treatment with a drug likely to cause markedly slow heart rate(<55bpm), low blood potassium level, slowing of intercardiac condition or prolongation of the QT interval The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

PANSS scores

Secondary Outcome Measures

Full Information

First Posted
May 30, 2006
Last Updated
April 8, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00331981
Brief Title
Amisulpride in Schizophrenic Patients
Official Title
Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary purpose: To find out how effective is long term treatment with amisulpride on the positive and negative symptoms in schizophrenic patients To find out how safe is long term treatment with amisulpride in schizophrenic patients Secondary purpose: To find out how effective is long term treatment with amisulpride on the quality of life in schizophrenic patients To find out how effective is long term treatment with amisulpride on the cognitive function in schizophrenic patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
138 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amisulpride
Primary Outcome Measure Information:
Title
PANSS scores
Time Frame
at every visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed as schizophrenia or schizophrenic disorder according to DSM-IV Patients who need new anti-psychotic drugs or need to change the medication due to aggravations of symptoms or recurrence Exclusion Criteria: Patients with positive symptoms in whom the disorder does not correspond to schizophrenic criteria. (e.g, schizoaffective disorder) Patients hypersensitive to the active ingredient or to other ingredients of the study drug Prolactin-dependant tumors, pituitary gland prolactinomas and breast cancer Pheochromocytoma or Parkinson's disease Pregnancy or breast feeding Current or recently withdrawn from drug abuse or alcoholism Chronic renal failure and other internal or surgical disease which physician decides will be worsened by trial medication or that will affect the metabolism or effects of the trial medication Patients with previous histories and clinical improvement was not seen in spite of treatment with 2 anti-psychotics for over 8 weeks Slow heart rate of <55bpm, low blood potassium level, congenital prolongation of the QT interval Current treatment with a drug likely to cause markedly slow heart rate(<55bpm), low blood potassium level, slowing of intercardiac condition or prolongation of the QT interval The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Sik Lee, MD, PhD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Amisulpride in Schizophrenic Patients

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