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Trial registered on ANZCTR
Registration number
ACTRN12611000293965
Ethics application status
Not yet submitted
Date submitted
24/02/2011
Date registered
21/03/2011
Date last updated
2/02/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
The Effects of Low Dose Sertraline on Blood Pressure in Patients with Hypertension and Panic Disorder: A Pilot Study
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Scientific title
Effect of low dose Sertraline on systolic and diastolic blood pressure in medically stable and competent patients with hypertension and panic disorder as classified by the AHA and DSM-IV respectively
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Secondary ID [1]
259675
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N/A
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Universal Trial Number (UTN)
N/A
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Trial acronym
N/A
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension related to Panic Disorders
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Condition category
Condition code
Cardiovascular
259392
259392
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0
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Hypertension
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Mental Health
259396
259396
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0
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Anxiety
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
We will review subjects 14 and 28 days post exposure to low dose sertraline (expected average dose = 50mg). Sertraline will be taken as an oral tablet, once daily.
Background:
Prior to commencment of study, patients will be confirmed to have hypertension and panic disorder by a clinical psychiatrist. Diagnosing Panic disorder will involve DSM-IV classification schemes
Patient's will be prescribed sertraline for their panic disorder (which is licensed as first line treatment for panic disorder in australia)
Patients will be recruited over a course of 3 months
In relation to dose:
Patients will initially start on 25mg sertraline for one week
One the second week patients will take 50mg
If there are no side effects and the patient is happy with the management of their panic, the dose will be maintained at 50mg. If side effects are prominent the dose can be lowered, and if the patient is not happy in the reduction in panic, the dose can be lowered. Determing dosage is at the descretion of the treating psychiatrist.
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Intervention code [1]
258106
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Not applicable
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome measure is the difference between the change in systolic and diastolic blood pressure in subjects, 14 and 28 days post exposure to low dose Sertraline (50mg final dose)
To assess this outcome, subjects will have 24hr ambulatory blood pressure monitoring at 0, 14 and 28 days. Blood pressure will be measured every half hour between 9am-9pm, and once every hour between 9pm-9am.
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Assessment method [1]
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Timepoint [1]
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0, 14 and 28 days
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Secondary outcome [1]
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nil
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Assessment method [1]
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Timepoint [1]
273337
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nil
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Eligibility
Key inclusion criteria
Age >40
Male or female
Diagnosed panic disorder/ anxiety disorder
Diagnosed hypertension and on at least one medication for hypertension
Compliant patient with access and availability to attend at least three (3) hospital sessions
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Cardiovascular Instability
Hypotension
Malignancy
Pregnancy or Breast-feeding
Involvement in another clinical trial
Current DSM-IV disorder (apart from Panic Disorder)
Hypersensitivity to, or currently using, any serotonergic medicines
Rural or remote location, or unable to attend for at least three (3) hospital sessions
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
258563
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Country [1]
258563
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Primary sponsor type
Individual
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Name
Professor Sean Hood
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Address
Queen Elizabeth II Medical Centre
The University of Western Australia (M521)
35 Stirling Highway
CRAWLEY WA 6009
Australia
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Country
Australia
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Secondary sponsor category [1]
257702
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Individual
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Name [1]
257702
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Associate Professor David Playford
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Address [1]
257702
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Cambridge Specialist Centre
Suite 1, 178 Cambridge Street
Wembley WA 6014
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Country [1]
257702
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
260619
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HUMAN RESEARCH ETHICS COMMITTEE - Fremantle Hospital
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Ethics committee address [1]
260619
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Human Research Ethics Office Room G5.27B Fremantle Hospital GPO Box 480 Fremantle, WA 6959
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Ethics committee country [1]
260619
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Australia
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Date submitted for ethics approval [1]
260619
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22/03/2011
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Approval date [1]
260619
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Ethics approval number [1]
260619
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Summary
Brief summary
The brain chemical serotonin is involved in both anxiety and the regulation of the autonomic nervous system (the main system involved in regulating blood pressure). A dysfunction relating to serotonin may explain why anxiety and hypertension often co-occur. Individuals with both a clinical anxiety disorder (Panic Disorder) and Hypertension will be offered a routine course of the serotonergic medication Sertraline – which is a licensed treatment of anxiety disorders in Australia. Participants continue to take their usual medications throughout the study, including antihypertensives. Blood pressure is studied over a one-month period This work may result in an improved understanding of the mechanisms by which hypertension and anxiety are linked, and may provide evidence to support targeted future therapies.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32268
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Address
32268
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Country
32268
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Phone
32268
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Fax
32268
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Email
32268
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Contact person for public queries
Name
15515
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Benjamin Mulo
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Address
15515
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13/18 Strang Street
Beaconsfield
WA 6162
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Country
15515
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Australia
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Phone
15515
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+61 (0)402867853
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Fax
15515
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Email
15515
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[email protected]
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Contact person for scientific queries
Name
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Professor Sean Hood
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Address
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Queen Elizabeth II Medical Centre
The University of Western Australia (M521)
35 Stirling Highway
CRAWLEY WA 6009
Australia
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Country
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Australia
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Phone
6443
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+61 8 9346 2393
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Fax
6443
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Email
6443
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[email protected]
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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.
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