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Panic Disorder and Cardiac Risk
This study is currently recruiting participants.
Verified by Baker Heart Research Institute, April 2007
First Received: September 10, 2005   Last Updated: April 4, 2007   History of Changes
Sponsor: Baker Heart Research Institute
Collaborator: National Health and Medical Research Council, Australia
Information provided by: Baker Heart Research Institute
ClinicalTrials.gov Identifier: NCT00168506
  Purpose

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 Intervention
Panic Disorder
Drug: SSRI
Drug: CBT
Drug: CBT/SSRI

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title: Panic Disorder and Cardiac Risk: Evaluation of a Psychological Treatment Which Addresses Biology, Psychology and Behaviour

Resource links provided by NLM:


Further study details as provided by Baker Heart Research Institute:

Estimated Enrollment: 50
Study Start Date: June 2002
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Panic disorder

Exclusion Criteria:

  • Comorbid heart disease
  • Comorbid significant psychiatric illness
  • Significant suicide risk
  • HIV/AIDS hepatitis B/c
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168506

Contacts
Contact: David A Barton, MBBSFRANZCP 61393428946 david.barton@bigpond.com
Contact: Murray Esler, PhD 61385321338 Murray.Esler@baker.edu.au

Locations
Australia, Victoria
Baker Heart Research Institute Recruiting
Melbourne, Victoria, Australia, 3121
Contact: David A Barton, MBBS     61393428946     david.barton@bigpond.com    
Sub-Investigator: David A Barton, MBBS            
Sponsors and Collaborators
Baker Heart Research Institute
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Murray A Esler, MBBS Phd Baker Heart Research Insitute
  More Information

No publications provided

Study ID Numbers: NHMRC P - 01
Study First Received: September 10, 2005
Last Updated: April 4, 2007
ClinicalTrials.gov Identifier: NCT00168506     History of Changes
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Baker Heart Research Institute:
panic disorder
cardiac risk

Additional relevant MeSH terms:
Panic Disorder
Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 08, 2010