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Amisulpride in Schizophrenic Patients

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00331981
Collaborator
(none)
138
Enrollment
1
Location

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients
Study Start Date :
Feb 1, 2004

Outcome Measures

Primary Outcome Measures

  1. PANSS scores [at every visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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  • Current or recently withdrawn from drug abuse or alcoholism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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanofi-Aventis Seoul Korea, Republic of

Sponsors and Collaborators

  • Sanofi

Investigators

  • Study Director: Won Sik Lee, MD, PhD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00331981
Other Study ID Numbers:
  • L_8968
First Posted:
May 31, 2006
Last Update Posted:
Apr 10, 2008
Last Verified:
Apr 1, 2008
Additional relevant MeSH terms:
Schizophrenia
Amisulpride

Study Results

No Results Posted as of Apr 10, 2008