Amisulpride Naturalistic Study

Phase 3

Recruiting

• Conditions: Schizophrenia and Schiaffective disorders; Mental Health - Schizophrenia

• Registration Number: ACTRN12605000656639
• Lead Sponsor: Dr. Suresh Sundram

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS). [PANSS will be administered on all visits except the second one.]