Amisulpride in Schizophrenic Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00331981 |
Recruitment Status :
Completed
First Posted : May 31, 2006
Last Update Posted : April 10, 2008
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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 |
---|---|---|
Schizophrenia | Drug: Amisulpride | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 138 participants |
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 : | February 2004 |

- PANSS scores [ Time Frame: at every visit ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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- Current or recently withdrawn from drug abuse or alcoholism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.

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): NCT00331981
Korea, Republic of | |
Sanofi-Aventis | |
Seoul, Korea, Republic of |
Study Director: | Won Sik Lee, MD, PhD | Sanofi |
ClinicalTrials.gov Identifier: | NCT00331981 |
Other Study ID Numbers: |
L_8968 |
First Posted: | May 31, 2006 Key Record Dates |
Last Update Posted: | April 10, 2008 |
Last Verified: | April 2008 |
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 |