Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000656639
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
18/10/2005
Date last updated
18/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Amisulpride Naturalistic Study
Scientific title
A Naturalistic, effectiveness and efficacy study of Amisulpride in the treatment of Schizophrenia and Schizoaffective disorder
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia and Schiaffective disorders 789 0
Condition category
Condition code
Mental Health 864 864 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Naturalistic, open label, flexible dosing using amasupride for six months.
Intervention code [1] 559 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1108 0
Positive and Negative Syndrome Scale (PANSS).
Timepoint [1] 1108 0
PANSS will be administered on all visits except the second one.
Secondary outcome [1] 2046 0
I Biometric Data
1. Blood Pressure and Pulse will be collected at all visits
2. Lab Tests (Blood Glucose, Lipids, Prolactin Level, LFT, FBE, TFT, Urine Drug Screen) will be performed at visits 1, 5 and 9/Endpoint.
3 Electrocardiogram will be taken at visit 1 and at visit 9/Endpoint.
Timepoint [1] 2046 0
Secondary outcome [2] 2047 0
II Tolerability Data
1. Body Weight will be recorded at each visit
2. Side Effect Scales
The following scales will be administered at all visits
1. Barnes Akathisia Rating Scale (BARS)
2. Abnormal Involuntary Movement Scale (AIMS)
3. Simpson and Angus Rating Scale
Timepoint [2] 2047 0
Secondary outcome [3] 2048 0
III Functional Data
1. Clinical Global Impression (CGI) scale will be administered at visit 3 and every visit thereafter.
2. CGI – Severity (CGI-S) will be administered at visits 1, 3, 4 and every visit thereafter.
3. World Health Organization – Disability Assessment Schedule 2 (WHODAS 2) will be administered at visits 1 and 9/endpoing
4. Neuropsychological tests (RBANS, NART, PFRT, PEAR, WCST, GO – NO- GO tests) will be administered at visits 2 and 9/endpoint.
5. Assessment of Motor and Process skills (AMPS) will be administered at visits 1 and 9/endpoint
6. Clinician Rating Scale (CRS) will be administered at each visit.
Timepoint [3] 2048 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 953 0
Other
Name [1] 953 0
external
Country [1] 953 0
Primary sponsor type
Individual
Name
Dr. Suresh Sundram
Address
Country
Secondary sponsor category [1] 821 0
Commercial sector/Industry
Name [1] 821 0
Sinofi-Synthelabo
Address [1] 821 0
Country [1] 821 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2249 0
Northern Area Mental Health Facilities
Ethics committee address [1] 2249 0
Ethics committee country [1] 2249 0
Australia
Date submitted for ethics approval [1] 2249 0
Approval date [1] 2249 0
Ethics approval number [1] 2249 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35944 0
Address 35944 0
Country 35944 0
Phone 35944 0
Fax 35944 0
Email 35944 0
Contact person for public queries
Name 9748 0
Dr. Suresh Sundram
Address 9748 0
Northern Psychiatry Research Centre
Northern Hospital
185 Cooper Street
Epping Melbourne VIC 3076
Country 9748 0
Australia
Phone 9748 0
+61 3 84058917
Fax 9748 0
+61 3 84058913
Email 9748 0
Suresh.Sundram@mh.org.au
Contact person for scientific queries
Name 676 0
Dr. Suresh Sundram
Address 676 0
Northern Psychiatry Research Centre
Northern Hospital
185 Cooper Street
Epping Melbourne VIC 3076
Country 676 0
Australia
Phone 676 0
+61 3 84058917
Fax 676 0
+61 3 84058913
Email 676 0
Suresh.Sundram@mh.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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