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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12609001013257 |
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Date of registration:
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23/11/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Methylphenidate for Borderline Personality Disorder in Adolescents
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Scientific title:
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An open-label trial to evaluate the effect of the psychostimulant Methylphenidate on the severity of Borderline Personality Disorder in Adolescents. |
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Date of first enrolment:
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18/01/2010 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://anzctr.org.au/ACTRN12609001013257.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Georgios Liangas
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Address:
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Redbank House
Institute Rd
Westmead NSW 2145
Australia |
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Telephone:
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+61 2 9845 6577 |
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Email:
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georgios.liangas@swahs.health.nsw.gov.au |
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Affiliation:
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Name:
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Dr Georgios Liangas
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Address:
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Redbank House
Institute Rd
Westmead NSW 2145
Australia |
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Telephone:
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+61 2 9845 6577 |
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Email:
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georgios.liangas@swahs.health.nsw.gov.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Adolescent females with a diagnosis of Borderline Personality Disorder
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.
Age minimum:
12 Years
Age maximum:
18 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Borderline Personality Disorder (BPD);
Borderline Personality Disorder (BPD)
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Mental Health - Psychosis and personality disorders
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Intervention(s)
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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.
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Primary Outcome(s)
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Clinical Global Impression Scale-Severity (CGI-S), measuring symptom severity and degree of interpersonal functioning.[Before treatment, at the end of 12-week treatment trial, and after a further 12 weeks.]
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Secondary Outcome(s)
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Nil[Nil]
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Source(s) of Monetary Support
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Concord Hospital, Department of Psychiatry
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Ethics review
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Status: Not approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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