- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168506
Panic Disorder and Cardiac Risk
Panic Disorder and Cardiac Risk: Evaluation of a Psychological Treatment Which Addresses Biology, Psychology and Behaviour
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3121
- Recruiting
- Baker Heart Research Institute
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Contact:
- David A Barton, MBBS
- Phone Number: 61393428946
- Email: david.barton@bigpond.com
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Sub-Investigator:
- David A Barton, MBBS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Panic disorder
Exclusion Criteria:
- Comorbid heart disease
- Comorbid significant psychiatric illness
- Significant suicide risk
- HIV/AIDS hepatitis B/c
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Murray A Esler, MBBS Phd, Baker Heart Research Insitute
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHMRC P - 01
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