RecruitingPhase 3ACTRN12605000656639

Amisulpride Naturalistic Study

A Naturalistic, effectiveness and efficacy study of Amisulpride in the treatment of Schizophrenia and Schizoaffective disorder


Sponsor

Dr. Suresh Sundram

Enrollment

40 participants

Start Date

Nov 1, 2004

Study Type

Interventional

Conditions

Summary

This project is a trial of amisulpride in the treatment of schizophrenia and schizoaffective disorder over a 24-week period. Atypical antipsychotic medications, such as amisulpride, are being used more and more to treat the debilitating effects of psychotic symptoms. The trial will be conducted over a 24-week period. It is expected that 40 patients will be recruited to this project. During the 24 weeks, parameters such as tolerability and safety will be assessed using a number of well validated Extra-Pyramidal Side Effects scales in addition to regular monitoring of vital signs, lab, and ECG results. Efficacy assessments will include the PANSS, CGI scales and an appropriate quality of life scale. Patients will also be administered a battery of neuropsychological tests at baseline and 24 weeks to assess and monitor change in cognitive function. Data will be processed using standard statistical techniques.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a medicine called amisulpride for people diagnosed with schizophrenia or schizoaffective disorder. Amisulpride is an 'atypical' antipsychotic, which means it is a newer type of medication that may have fewer side effects than older antipsychotics. The study lasts 24 weeks and will look at how safe and effective amisulpride is, how it affects quality of life, and how it impacts thinking and memory. You may be eligible if: - You are between 18 and 65 years old - You have been diagnosed with schizophrenia (any type) or schizoaffective disorder - Your doctor thinks it is appropriate for you to try amisulpride — for example, because your current medication is not working well or causing side effects, or you have just been diagnosed You may NOT be eligible if: - You have a different primary psychiatric diagnosis (other than schizophrenia or schizoaffective disorder) - You are known to be allergic or sensitive to amisulpride - You have had Neuroleptic Malignant Syndrome (a serious reaction to antipsychotic medicines) - You have a significant abnormal ECG (heart tracing) - You were previously taking clozapine for treatment-resistant psychosis - You have not had a response problem with your current antipsychotic and do not need a switch Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Naturalistic, open label, flexible dosing using amasupride for six months.

Naturalistic, open label, flexible dosing using amasupride for six months.


Locations(1)

Australia

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ACTRN12605000656639