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Panic Disorder and Cardiac Risk

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Baker Heart Research Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168506
First Posted: September 15, 2005
Last Update Posted: April 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
Baker Heart Research Institute
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00168506     History of Changes
Other Study ID Numbers: NHMRC P - 01
First Submitted: September 10, 2005
First Posted: September 15, 2005
Last Update Posted: April 5, 2007
Last Verified: April 2007

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

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