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Panic Disorder and Cardiac Risk

Primary Purpose

Panic Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
SSRI
CBT
CBT/SSRI
Sponsored by
Baker Heart Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring panic disorder, cardiac risk

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Panic disorder Exclusion Criteria: Comorbid heart disease Comorbid significant psychiatric illness Significant suicide risk HIV/AIDS hepatitis B/c

Sites / Locations

  • Baker Heart Research InstituteRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 10, 2005
Last Updated
April 4, 2007
Sponsor
Baker Heart Research Institute
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00168506
Brief Title
Panic Disorder and Cardiac Risk
Official Title
Panic Disorder and Cardiac Risk: Evaluation of a Psychological Treatment Which Addresses Biology, Psychology and Behaviour
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Baker Heart Research Institute
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
panic disorder, cardiac risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SSRI
Intervention Type
Drug
Intervention Name(s)
CBT
Intervention Type
Drug
Intervention Name(s)
CBT/SSRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Panic disorder Exclusion Criteria: Comorbid heart disease Comorbid significant psychiatric illness Significant suicide risk HIV/AIDS hepatitis B/c
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David A Barton, MBBSFRANZCP
Phone
61393428946
Email
david.barton@bigpond.com
First Name & Middle Initial & Last Name or Official Title & Degree
Murray Esler, PhD
Phone
61385321338
Email
Murray.Esler@baker.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murray A Esler, MBBS Phd
Organizational Affiliation
Baker Heart Research Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baker Heart Research Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David A Barton, MBBS
Phone
61393428946
Email
david.barton@bigpond.com
First Name & Middle Initial & Last Name & Degree
David A Barton, MBBS

12. IPD Sharing Statement

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Panic Disorder and Cardiac Risk

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