Status:
COMPLETED
Neurobiological Mechanisms in Panic Disorder
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Panic Disorder
Eligibility:
All Genders
18-60 years
Brief Summary
This study will examine brain and noradrenaline function in panic disorder. Noradrenaline is a brain chemical that is involved in the regulation of emotion, anxiety, sleep, stress hormones such as cor...
Detailed Description
A considerable body of preclinical and clinical evidence suggests that dysregulated activity of noradrenergic systems in the brain is involved in the development of mood disturbance, anxiety, and fear...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Up to 120 drug-free subjects (ages 18-60) will be selected who additionally meet criteria for one of 3 subgroups:
- I. PD, current (n=30), as defined by DSM-IV criteria for PD, and still symptomatic as defined by at least 1 panic attack/week or a CGI score of at least 4. In case of co-morbid depression it will be ensured that PD is the primary diagnosis. This means that PD preceded the onset of MDD. These patients will be drug-free for at least 2 weeks prior to being enrolled in the study.
- II. PD, remitted (n=30), as defined by DSM-IV criteria for PD, and asymptomatic as no longer meeting criteria for PD while being drug-free during the past 6 months.
- III. Healthy Control Sample. Sixty subjects (ages 18-60) who have not met criteria for any major psychiatric disorder (axis I diagnosis according to DSM-IV). A control subject will be matched to each PD subject for age, gender, menopausal and estrogen replacement status, and handedness. The control subjects will have no known first-degree relatives with any axis I disorder.
- EXCLUSION CRITERIA:
- Symptomatic PD patients must not have taken any antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function for at least 2 weeks prior to the challenge studies.
- Remitted PD patients will be drug-free for at least 6 months prior to enrollment.
- Subjects will also be excluded if they have:
- evidence for an axis I psychiatric disorder (DSM-IV criteria) other than panic disorder with/without agoraphobia with/without comorbid depression,
- medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders, seizures,
- a history of drug (including BZDs) or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM IV criteria),
- current pregnancy (as documented by pregnancy testing at screening or on the days of the challenge studies),
- current breast feeding,
- are smokers,
- presence of an axis II personality disorder,
- current treatment with fluoxetine, or
- history of an adverse reaction associated with the administration of yohimbine.
- Subjects beyond age 60 are excluded.
Exclusion
Key Trial Info
Start Date :
February 14 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 12 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00103987
Start Date
February 14 2005
End Date
November 12 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892