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Trial registered on ANZCTR


Trial ID
ACTRN12605000322639
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
6/09/2005
Date last updated
8/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Label Study of the use of Aripiprazole in the Treatment of Chronic Post Traumatic Stress Disorder
Scientific title
A pilot Open Label Study of Aripiprazole as Add On Therapy in Post Traumatic Stress disorder as measured by impact on CAPS-2 scores
Secondary ID [1] 288094 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic stress Disorder 410 0
Condition category
Condition code
Mental Health 481 481 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 week Open label prescription of Aripiprazole, in addition to any current anti-depressant therapy.
Intervention code [1] 326 0
Treatment: Drugs
Comparator / control treatment
No comparator - open label study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 552 0
Change in CAPS2 score from baseline over 8 weeks treatment
Timepoint [1] 552 0
At the end of the study.
Secondary outcome [1] 1170 0
Change in HAM-D, CGI, PCL, AUDIT and DAR scores over same time period.
Timepoint [1] 1170 0
At the end of the study.

Eligibility
Key inclusion criteria
PTSD according to DSM-IV criteria and a baseline CAPS 2 score greater than 50.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current substance use disorder.

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 2
Type of endpoint(s)
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)
VIC
Recruitment hospital [1] 4863 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Funding & Sponsors
Funding source category [1] 547 0
Commercial sector/Industry
Name [1] 547 0
Bristol Myers Squibb Pharmaceuticals
Address [1] 547 0
556 Princess Highway
Noble Park Vic 3174
Country [1] 547 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg, Vic 3084
Country
Australia
Secondary sponsor category [1] 441 0
None
Name [1] 441 0
Nil
Address [1] 441 0
Country [1] 441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1549 0
Austin Hospital HREC
Ethics committee address [1] 1549 0
145 Studley Rd, Heidelberg Vic 3081
Ethics committee country [1] 1549 0
Australia
Date submitted for ethics approval [1] 1549 0
Approval date [1] 1549 0
02/02/2006
Ethics approval number [1] 1549 0

Summary
Brief summary
This clinical research study was completed in 2009.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 36127 0
A/Prof Malcolm Hopwood
Address 36127 0
145 Studley Road
Heidelberg Vic 3084
Country 36127 0
Australia
Phone 36127 0
+61 3 9496 2750
Fax 36127 0
Email 36127 0
mhopwood@austin.org.au
Contact person for public queries
Name 9515 0
A/Prof Associate Professor Malcolm Hopwoood
Address 9515 0
Department of Psychiatry
Heidelberg Repatriation Hospital
Banksia St
Heidleberg West VIC 3081
Country 9515 0
Australia
Phone 9515 0
+61 3 94962360
Fax 9515 0
+61 3 94962360
Email 9515 0
malcolm.hopwood@austin.org.au
Contact person for scientific queries
Name 443 0
Ms Iveta Krivonos
Address 443 0
Department of Psychiatry
Heidelberg Repatriation Hospital
Banksia St
Heidleberg West VIC 3081
Country 443 0
Australia
Phone 443 0
+61 3 94964339
Fax 443 0
+61 3 94962360
Email 443 0
iveta.krivonos@austin.org.au