Status:
COMPLETED
Genetic Causes of Panic Disorder
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Panic Disorder
Eligibility:
All Genders
18-60 years
Brief Summary
This study will try to identify genes that increase the risk of developing panic disorder-an anxiety disorder characterized by recurrent unexpected panic attacks-and that contribute to the abnormaliti...
Detailed Description
Caffeine, the most widely used psychoactive drug in the world, exerts its behavioral effects by antagonizing adenosine receptors (AR). Four different human AR subtypes have been found and there is evi...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male or female subjects between ages 18 to 60.
- Panic patients with a primary diagnosis of current Panic Disorder without Agoraphobia (300.01) or Panic Disorder with Agoraphobia (300.21) according to DSM-IV criteria. Patients with co-morbid Major Depressive Disorder will be included provided there has been a period of at least 3 months where Panic Disorder, was present in the absence of Major Depressive Disorder or Patients with a past history of Panic Disorder, currently in remission. Remission is defined by as not meeting criteria for Panic Disorder for at least 3 months (no panic attacks in 3 months and less than 5 PDSS score for past month) and off treatment for at least 3 months immediately prior to study entry.
- Subjects must be competent to comprehend the purpose of the study and provide written informed consent.
- If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable method(s) of contraception (eg, hormonal intrauterine device), for at least one month prior to study entry and throughout the study.
- Subjects must be psychotropic medication free for at lest 14 days prior to the caffeine/placebo challenge sessions; for fluoxetine at least 4 weeks.
- Caffeine free diet for at least 7 days prior to the caffeine/placebo challenge sessions.
- EXCLUSION CRITERIA:
- Subjects should have no general medical illness that is causing the panic disorder.
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease.
- Subjects with known cardiac disease.
- Subjects with one or more past seizures without a clear and resolved etiology.
- Patients who would be unable to comply with study procedures or assessments.
- Patients who are currently at high risk for homicide or suicide.
- Patients with psychotic features.
- Patients with current DSM-IV substance abuse or dependence within the past year.
- Patients who are on a non-psychotropic medication with psychotropic effects (e.g., beta-adrenergic blockers) unless the dosage has been stable for a minimum of one month prior to the study.
- Subjects with a positive HIV test result.
- Experimental treatment in the past one month.
- For healthy volunteers, no current or past history of any psychiatric disorder.
- Exclude subjects taking CYP1A2 inhibitors.
- Exclude subjects with prostatitis.
Exclusion
Key Trial Info
Start Date :
May 13 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 14 2018
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00083265
Start Date
May 13 2004
End Date
February 14 2018
Last Update
February 19 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892