Amisulpride in Schizophrenic Patients

Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00331981

Enrollment

138

Registered

2006-05-31

Start date

2004-02-29

Completion date

Unknown

Last updated

2008-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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

Interventions

DRUGAmisulpride

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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and breast cancer * Pheochromocytoma or Parkinson's disease * Pregnancy or breast feeding * Current or recently withdrawn from drug abuse or alcoholism * Chronic renal failure and other internal or surgical disease which physician decides will be worsened by trial medication or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.

Design outcomes

Primary

Measure	Time frame
PANSS scores	at every visit

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026