Panic Disorder and Cardiac Risk

NCT ID: NCT00168506

Last Updated: 2007-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SSRI

Intervention Type DRUG

CBT

Intervention Type DRUG

CBT/SSRI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Panic disorder

Exclusion Criteria

* Comorbid heart disease
* Comorbid significant psychiatric illness
* Significant suicide risk
* HIV/AIDS hepatitis B/c
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Baker Heart Research Institute

OTHER

Sponsor Role lead

Principal Investigators

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Murray A Esler, MBBS Phd

Role: PRINCIPAL_INVESTIGATOR

Baker Heart Research Insitute

Locations

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Baker Heart Research Institute

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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David A Barton, MBBSFRANZCP

Role: CONTACT

61393428946

Murray Esler, PhD

Role: CONTACT

61385321338

Facility Contacts

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David A Barton, MBBS

Role: primary

61393428946

Other Identifiers

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NHMRC P - 01

Identifier Type: -

Identifier Source: org_study_id