Panic Disorder and Cardiac Risk
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|ClinicalTrials.gov Identifier: NCT00168506|
Recruitment Status : Unknown
Verified April 2007 by Baker Heart Research Institute.
Recruitment status was: Recruiting
First Posted : September 15, 2005
Last Update Posted : April 5, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Panic Disorder||Drug: SSRI Drug: CBT Drug: CBT/SSRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Panic Disorder and Cardiac Risk: Evaluation of a Psychological Treatment Which Addresses Biology, Psychology and Behaviour|
|Study Start Date :||June 2002|
|Estimated Study Completion Date :||December 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168506
|Contact: David A Barton, MBBSFRANZCPfirstname.lastname@example.org|
|Contact: Murray Esler, PhD||61385321338||Murray.Esler@baker.edu.au|
|Baker Heart Research Institute||Recruiting|
|Melbourne, Victoria, Australia, 3121|
|Contact: David A Barton, MBBS 61393428946 email@example.com|
|Sub-Investigator: David A Barton, MBBS|
|Principal Investigator:||Murray A Esler, MBBS Phd||Baker Heart Research Insitute|