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NCT00168506 Clinical Trial

Panic Disorder and Cardiac Risk

Panic Disorder Clinical Trial

Official title:
Panic Disorder and Cardiac Risk: Evaluation of a Psychological Treatment Which Addresses Biology, Psychology and Behaviour

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00168506
Other study ID # NHMRC P - 01
Secondary ID
Status Recruiting
Phase N/A
First received September 10, 2005
Last updated April 4, 2007
Start date June 2002
Est. completion date December 2008

Study information
Verified date April 2007
Source Baker Heart Research Institute
Contact David A Barton, MBBSFRANZCP
Phone 61393428946
Email david.barton@bigpond.com
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Panic disorder

Exclusion Criteria:

- Comorbid heart disease

- Comorbid significant psychiatric illness

- Significant suicide risk

- HIV/AIDS hepatitis B/c

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SSRI

• CBT

• CBT/SSRI

Locations
Country Name City State
Australia Baker Heart Research Institute Melbourne Victoria

Sponsors (2)
Lead Sponsor Collaborator
Baker Heart Research Institute National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

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