Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001013257
Ethics application status
Not yet submitted
Date submitted
18/11/2009
Date registered
23/11/2009
Date last updated
23/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Methylphenidate for Borderline Personality Disorder in Adolescents
Scientific title
An open-label trial to evaluate the effect of the psychostimulant Methylphenidate on the severity of Borderline Personality Disorder in Adolescents.
Secondary ID [1] 1141 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder (BPD) 252237 0
Condition category
Condition code
Mental Health 252423 252423 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All eligible patients will receive methylphenidate IR (immediate release oral tablet) treatment for 12 weeks, at an initial dose of 0.5mg/kg/day, correct to the
nearest 5mg, in 2 divided doses, and increased over 4 weeks, at the discretion of the researcher based on the severity of illness and response to the prescribed dose; to a maximum of 1mg/kg/day in 3 divided doses.
Intervention code [1] 241570 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253298 0
Clinical Global Impression Scale-Severity (CGI-S), measuring symptom severity and degree of interpersonal functioning.
Timepoint [1] 253298 0
Before treatment, at the end of 12-week treatment trial, and after a further 12 weeks.
Secondary outcome [1] 262330 0
Nil
Timepoint [1] 262330 0
Nil

Eligibility
Key inclusion criteria
Adolescent females with a diagnosis of Borderline Personality Disorder
Minimum age
12 Years
Maximum age
18 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Comorbid diagnosis of Autistic Spectrum Disorder, clinically evident mental retardation or a tick disorder.
- Comorbid diagnosis of a significant medical disorder, such as active hepatic or renal disease, dementia, serious head injury or active cancer.
- Marked previous or current anxiety or psychotic symptoms.

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)
The proposed sample will be 30 female adolescent patients with BPD. Patients will be recruited from adolescent outpatient clinics in the inner western suburbs of Sydney.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244049 0
Hospital
Name [1] 244049 0
Concord Hospital, Department of Psychiatry
Country [1] 244049 0
Australia
Primary sponsor type
Hospital
Name
Concord Hospital, Department of Psychiatry
Address
Hospital Rd
Concord West NSW 2138
Country
Australia
Secondary sponsor category [1] 251395 0
None
Name [1] 251395 0
n/a
Address [1] 251395 0
n/a
Country [1] 251395 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258143 0
Ethics committee address [1] 258143 0
Ethics committee country [1] 258143 0
Date submitted for ethics approval [1] 258143 0
21/10/2009
Approval date [1] 258143 0
Ethics approval number [1] 258143 0
HREC/09/CRGH/219

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

Contacts
Principal investigator
Name 30526 0
Address 30526 0
Country 30526 0
Phone 30526 0
Fax 30526 0
Email 30526 0
Contact person for public queries
Name 13773 0
Dr Georgios Liangas
Address 13773 0
Redbank House
Institute Rd
Westmead NSW 2145
Country 13773 0
Australia
Phone 13773 0
+61 2 9845 6577
Fax 13773 0
Email 13773 0
[email protected]
Contact person for scientific queries
Name 4701 0
Dr Georgios Liangas
Address 4701 0
Redbank House
Institute Rd
Westmead NSW 2145
Country 4701 0
Australia
Phone 4701 0
+61 2 9845 6577
Fax 4701 0
Email 4701 0
[email protected]

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
No additional documents have been identified.