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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
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
Secondary ID [1] 259675 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension related to Panic Disorders 261244 0
Condition category
Condition code
Cardiovascular 259392 259392 0 0
Hypertension
Mental Health 259396 259396 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 258106 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262210 0
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.
Timepoint [1] 262210 0
0, 14 and 28 days
Secondary outcome [1] 273337 0
nil
Timepoint [1] 273337 0
nil

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258563 0
Self funded/Unfunded
Name [1] 258563 0
Country [1] 258563 0
Primary sponsor type
Individual
Name
Professor Sean Hood
Address
Queen Elizabeth II Medical Centre
The University of Western Australia (M521)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country
Australia
Secondary sponsor category [1] 257702 0
Individual
Name [1] 257702 0
Associate Professor David Playford
Address [1] 257702 0
Cambridge Specialist Centre
Suite 1, 178 Cambridge Street
Wembley WA 6014
Country [1] 257702 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260619 0
HUMAN RESEARCH ETHICS COMMITTEE - Fremantle Hospital
Ethics committee address [1] 260619 0
Human Research Ethics Office
Room G5.27B
Fremantle Hospital
GPO Box 480
Fremantle, WA 6959
Ethics committee country [1] 260619 0
Australia
Date submitted for ethics approval [1] 260619 0
22/03/2011
Approval date [1] 260619 0
Ethics approval number [1] 260619 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32268 0
Address 32268 0
Country 32268 0
Phone 32268 0
Fax 32268 0
Email 32268 0
Contact person for public queries
Name 15515 0
Benjamin Mulo
Address 15515 0
13/18 Strang Street
Beaconsfield
WA 6162
Country 15515 0
Australia
Phone 15515 0
+61 (0)402867853
Fax 15515 0
Email 15515 0
[email protected]
Contact person for scientific queries
Name 6443 0
Professor Sean Hood
Address 6443 0
Queen Elizabeth II Medical Centre
The University of Western Australia (M521)
35 Stirling Highway
CRAWLEY WA 6009
Australia
Country 6443 0
Australia
Phone 6443 0
+61 8 9346 2393
Fax 6443 0
Email 6443 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

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Documents added automatically
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