COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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

Study type
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


Key inclusion criteria
- Panic disorder
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Comorbid heart disease

- Comorbid significant psychiatric illness

- Significant suicide risk

- HIV/AIDS hepatitis B/c

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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

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

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see