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Panic Disorder and Cardiac Risk

Sponsor
Baker Heart Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT00168506
Collaborator
National Health and Medical Research Council, Australia (Other)
50
Enrollment
1
Location
78
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
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
Study Start Date :
Jun 1, 2002
Anticipated Study Completion Date :
Dec 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Panic disorder
    Exclusion Criteria:

    • Comorbid heart disease

    • Comorbid significant psychiatric illness

    • Significant suicide risk

    • HIV/AIDS hepatitis B/c

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baker Heart Research Institute Melbourne Victoria Australia 3121

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00168506
    Other Study ID Numbers:
    • NHMRC P - 01
    First Posted:
    Sep 15, 2005
    Last Update Posted:
    Apr 5, 2007
    Last Verified:
    Apr 1, 2007
    Keywords provided by , ,
    panic disorder
    cardiac risk
    Additional relevant MeSH terms:
    Disease
    Panic Disorder

    Study Results

    No Results Posted as of Apr 5, 2007