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Trial registered on ANZCTR


Registration number
ACTRN12605000577617
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
4/10/2005
Date last updated
18/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mirtazapine add-on therapy in the treatment of schizophrenia with atypical neuroleptics: A double-blind, randomised, placebo controlled trial
Scientific title
Mirtazapine add-on therapy in the treatment of schizophrenia with atypical neuroleptics: A double-blind, randomised, placebo controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 704 0
Condition category
Condition code
Mental Health 782 782 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6-week trial of mirtazapine (30 mg/day) in addition to antipsychotic treatment as usual.
Intervention code [1] 598 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 992 0
Significant difference by week 6 between mirtazapine treated and placebo treated groups using the Positive and negative symptoms scale (PANSS).
Timepoint [1] 992 0
Measurements at baseline and weeks 1, 2, 4 and 6.
Secondary outcome [1] 1880 0
Clinical global impression (CGI)
Timepoint [1] 1880 0
Measured at baseline, and at weeks 1, 2, 4 and 6.
Secondary outcome [2] 1881 0
Hamilton Depression rating scale (HAMD)
Timepoint [2] 1881 0
Measured at baseline, and at weeks 1, 2, 4 and 6.
Secondary outcome [3] 1882 0
Simpson Angus Scale
Timepoint [3] 1882 0
Measured at baseline, and at weeks 1, 2, 4 and 6.

Eligibility
Key inclusion criteria
Diagnosis of schizophrenia confirmed by the Mini International Neuropsychiatric Interview (MINI).Currently being treated with an atypical antipsychotic.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with significant medical illnesses and patients on any other psychotropic agents except benzodiazepines, patients who have a history of any other major psychiatric disorder, and patients meeting criteria for substance abuse or who regularly consume over 3 alcoholic drinks daily, pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
placebo and mirtazapine tablets identical in appearance and in a coded container
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation log generated by coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 860 0
Commercial sector/Industry
Name [1] 860 0
Organon
Address [1] 860 0
Schering-Plough Pty Limited
Level 4, 66 Waterloo Road
North Ryde NSW 2113
Country [1] 860 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville
Victoria 3010
Country
Australia
Secondary sponsor category [1] 729 0
Hospital
Name [1] 729 0
Royal Adelaide Hospital
Address [1] 729 0
Glenside Hospital
226 Fullerton Rd
Eastwood, Adelaide 5063
Country [1] 729 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2126 0
Barwon Health
Ethics committee address [1] 2126 0
Ethics committee country [1] 2126 0
Australia
Date submitted for ethics approval [1] 2126 0
Approval date [1] 2126 0
Ethics approval number [1] 2126 0
Ethics committee name [2] 2127 0
Glenside Hospital
Ethics committee address [2] 2127 0
Ethics committee country [2] 2127 0
Australia
Date submitted for ethics approval [2] 2127 0
Approval date [2] 2127 0
Ethics approval number [2] 2127 0
Ethics committee name [3] 2128 0
Northern Health
Ethics committee address [3] 2128 0
Ethics committee country [3] 2128 0
Australia
Date submitted for ethics approval [3] 2128 0
Approval date [3] 2128 0
Ethics approval number [3] 2128 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35423 0
Address 35423 0
Country 35423 0
Phone 35423 0
Fax 35423 0
Email 35423 0
Contact person for public queries
Name 9787 0
Dr Seetal Dodd
Address 9787 0
Swanston Centre
Barwon Health
PO Box 281
Geelong VIC 3220
Country 9787 0
Australia
Phone 9787 0
+61 3 52267666
Fax 9787 0
+61 3 52465165
Email 9787 0
seetald@barwonhealth.org.au
Contact person for scientific queries
Name 715 0
Dr Seetal Dodd
Address 715 0
Swanston Centre
Barwon Health
PO Box 281
Geelong VIC 3220
Country 715 0
Australia
Phone 715 0
+61 3 52267666
Fax 715 0
+61 3 52465165
Email 715 0
seetald@barwonhealth.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary