Amisulpride Naturalistic Study

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000656639

Enrollment

Registered

2005-10-18

Start date

2004-11-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1.DSM-IV-TR Diagnosis of schizophrenia (any sub-type) or schizoaffective disorder, confirmed by the M.I.N.I. 2.Subject has read and understood the Plain Language Statement and signed the approved Informed Consent Form. 3.Subject is considered suitable by the Investigator to be treated with amisulpride (eg. Subjects requiring a switch to amisulpride due to poor efficacy and/or tolerability with a pre-study therapeutic antipsychotic medication, based on the clinical judgment of the investigator; subjects recently diagnosed with schizophrenia (any sub-type) or schizoaffective disorder; subjects currently taking amisulpride as the main therapeutic antipsychotic). 4.Subjects currently taking amisulpride as the main therapeutic antipsychotic medication.

Exclusion criteria

1.A current DSM-IV-TR diagnosis other than Schizophrenia (any sub-type) or Schizoaffective disorder. 2.Known hypersensitivity to amisulpride3.History of severe drug allergy or hypersensitivity4.Subjects known to be unresponsive to amisulpride5.History of Neuroleptic Malignant syndrome6.Have a clinically significant ECG abnormality that, in the opinion of the Investigator, may be adversely affected by the medication under study.7.Subjects on depot medication who have not reached one treatment cycle at the baseline point 8.Subjects taking clozapine as the previous antipsychotic, for treatment-resistant psychosis, which intended to treat their schizophrenia or schizoaffective disorder prior to entry into the project.9.Subjects who do not require a switch to amisulpride due to poor efficacy and/or tolerability with a pre-study therapeutic antipsychotic medication, based on the clinical judgment of the investigator.

Outcome results