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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00168506
Registration number
NCT00168506
Ethics application status
Date submitted
10/09/2005
Date registered
15/09/2005
Date last updated
5/04/2007
Titles & IDs
Public title
Panic Disorder and Cardiac Risk
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Scientific title
Panic Disorder and Cardiac Risk: Evaluation of a Psychological Treatment Which Addresses Biology, Psychology and Behaviour
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Secondary ID [1]
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NHMRC P - 01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Panic Disorder
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Condition category
Condition code
Mental Health
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SSRI
Treatment: Drugs - CBT
Treatment: Drugs - CBT/SSRI
Treatment: Drugs: SSRI
Treatment: Drugs: CBT
Treatment: Drugs: CBT/SSRI
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
- Panic disorder
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Minimum age
18
Years
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Maximum age
65
Years
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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
- Comorbid heart disease
- Comorbid significant psychiatric illness
- Significant suicide risk
- HIV/AIDS hepatitis B/c
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2002
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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
1/12/2008
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker Heart Research Institute - Melbourne
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Recruitment postcode(s) [1]
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3121 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Baker Heart Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The reason for increased cardiac mortality in panic disorder has not been precisely
identified, but possibly is due to chronic activation of the cardiac stimulant (sympathetic)
nerves, which may predispose the individual with panic disorder to disorders of cardiac
rhythm and coronary artery spasm. The uniqueness of this study lies in its comprehensive
evaluation of a psychobiological approach to the treatment of panic disorder using change in
biological, behavioural and psychological variables as criteria for efficacy. 50 patients
aged between 18 and 60 years will be recruited; both males and females. They will be treated
with either cognitive behavioural therapy (CBT) or SSRI (selective serotonin re-uptake
inhibitor) antidepressants or a combination of both.
This project will firstly compare individuals with panic disorder who demonstrate abnormal
brain transmitter (noradrenaline, serotonin) with those who demonstrate normal activity of
these neurotransmitters, on interoceptive accuracy for changes in sympathetic nervous system
arousal. It is predicted that individuals who demonstrate abnormal activity of these
neurotransmitters will also demonstrate enhanced interoceptive ability to detect changes in
arousal levels. Secondly, this project will evaluate the effects of a psychobiological
treatment approach to panic disorder involving a combination of CBT and SSRI. This approach
will be compared to the effects of both these interventions alone on a comprehensive array of
measures related to panic disorder. It is predicted that the combined approach will be the
most effective intervention on behavioural, psychological and biological variables, and
cardiac risk. We will also be able to assess whether changes in panic disorder severity are
associated with changes in interoceptive accuracy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00168506
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Murray A Esler, MBBS Phd
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Address
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Baker Heart Research Insitute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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David A Barton, MBBSFRANZCP
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Address
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Country
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Phone
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61393428946
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00168506
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