Trial Review

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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
Scientific title
Panic Disorder and Cardiac Risk: Evaluation of a Psychological Treatment Which Addresses Biology, Psychology and Behaviour
Secondary ID [1] 0 0
NHMRC P - 01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Panic Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Panic disorder
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Comorbid heart disease

- Comorbid significant psychiatric illness

- Significant suicide risk

- HIV/AIDS hepatitis B/c

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2008
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3121 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00168506
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Murray A Esler, MBBS Phd
Address 0 0
Baker Heart Research Insitute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David A Barton, MBBSFRANZCP
Address 0 0
Country 0 0
Phone 0 0
61393428946
Fax 0 0
Email 0 0
david.barton@bigpond.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00168506