Panic Disorder and Cardiac Risk
1 other identifier
interventional
50
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedApril 5, 2007
April 1, 2007
September 10, 2005
April 4, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Panic disorder
You may not qualify if:
- Comorbid heart disease
- Comorbid significant psychiatric illness
- Significant suicide risk
- HIV/AIDS hepatitis B/c
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baker Heart Research Institute
Melbourne, Victoria, 3121, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Murray A Esler, MBBS Phd
Baker Heart Research Insitute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 15, 2005
Study Start
June 1, 2002
Study Completion
December 1, 2008
Last Updated
April 5, 2007
Record last verified: 2007-04