Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083265
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2004-05-15
Brief Title:
Genetic Causes of Panic Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Association Between Adenosine Receptor Gene Polymorphisms and Physiological Responses to Caffeine in Subjects With Panic Disorder and Healthy Controls
Status:
COMPLETED
Status Verified Date:
2018-02-14
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 abnormalities associated with it It will compare reactions in patients with panic disorder and in normal volunteers to caffeine a compound that can induce anxiety and to placebo an inactive substance Caffeine is believed to induce anxiety by blocking proteins called adenosine receptors on the surface of nerve cells in the brain One study found that people with a specific adenosine receptor gene called 1976TT had greater anxiety in response to caffeine challenge than did people with other adenosine receptor gene groups There is also evidence that people with the 1976TT genotype are more vulnerable to having panic disorder
Normal volunteers and patients with panic disorder with or without agoraphobia who are between 18 and 60 years of age may be eligible for this study Candidates are screened with physical and psychiatric examinations a diagnostic interview mood and anxiety ratings an electrocardiogram and blood and urine tests including genetic studies
Participants have two caffeineplacebo challenge sessions at least 3 days apart Each session lasts about 4 hours For at least 1 week before each session subjects follow a diet excluding foods with caffeine and refrain from drinking alcoholic beverages for at least 48 hours before the procedure The morning of the session following an overnight fast subjects swallow either a placebo capsule or a caffeine capsule that is equivalent to about 5 cups of coffee During the session subjects take a battery of neuropsychological tests to document changes in cognitive and emotional functioning including attention memory and motor performance In addition heart rate and blood pressure are measured 15 minutes before and 30 60 90 120 150 and 180 minutes after the caffeine or placebo dose
At the end of the study patients with panic disorder are eligible to receive routine clinical treatment for up to 3 months and may participate in planning for long-term treatment under the care of their local health care provider
Normal volunteers and patients with panic disorder with or without agoraphobia who are between 18 and 60 years of age may be eligible for this study Candidates are screened with physical and psychiatric examinations a diagnostic interview mood and anxiety ratings an electrocardiogram and blood and urine tests including genetic studies
Participants have two caffeineplacebo challenge sessions at least 3 days apart Each session lasts about 4 hours For at least 1 week before each session subjects follow a diet excluding foods with caffeine and refrain from drinking alcoholic beverages for at least 48 hours before the procedure The morning of the session following an overnight fast subjects swallow either a placebo capsule or a caffeine capsule that is equivalent to about 5 cups of coffee During the session subjects take a battery of neuropsychological tests to document changes in cognitive and emotional functioning including attention memory and motor performance In addition heart rate and blood pressure are measured 15 minutes before and 30 60 90 120 150 and 180 minutes after the caffeine or placebo dose
At the end of the study patients with panic disorder are eligible to receive routine clinical treatment for up to 3 months and may participate in planning for long-term treatment under the care of their local health care provider
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 evidence that the stimulatory effect of caffeine is mainly caused by an inhibition of transmission via adenosine A2a receptors A significant association has been found in healthy infrequent caffeine users between caffeine-induced anxiety and two linked polymorphisms on the A2a receptor gene the 1976C greater than T and 2592C greater than Tins polymorphisms In one study looking at monozygotic and dizygotic twin pairs there was much evidence that individual differences in caffeine use intoxication tolerance and withdrawal were substantially influenced by genetic factors Family and twin studies have shown that genetic factors may increase vulnerability to panic disorder In one study a systematic mutation screening and association study of the A1 and A2a adenosine receptor genes in panic disorder showed a significant association between the 1976T allele and 1976TT genotype of the A2a receptor gene and panic disorder As the 1976TT genotype of the A2a receptor gene has been associated with both increased caffeine-induced anxiety in healthy controls and has been associated with increased vulnerability to panic disorder we wish to study whether the 1976TT genotype in panic disorder patients is associated with increased caffeine-induced anxiety
This study will study subjects with panic disorder and healthy controls Based on previous studies the following hypotheses will be tested 2 replication and 2 new hypotheses Replication 1 panic disorder subjects will report higher anxiety after a caffeine challenge than the healthy control subjects 2 healthy controls with the1976 TT polymorphism will report increased anxiety after a caffeine challenge compared to healthy controls with the 1976 CT and 1976 CC genotypes New hypotheses 3 panic patients two separate groups currently ill and remitted with the 1976 TT polymorphism will report increased anxiety after a caffeine challenge compared to panic patients with the 1976 CT and 1976 CC genotypes 4 panic patients two separate groups currently ill and remitted with the 1976 TT polymorphism will report increased anxiety after a caffeine challenge compared to healthy controls with the 1976 TT polymorphism will report increased anxiety after a caffeine challenge compared to healthy controls with the 1976 TT genotype
This study will study subjects with panic disorder and healthy controls Based on previous studies the following hypotheses will be tested 2 replication and 2 new hypotheses Replication 1 panic disorder subjects will report higher anxiety after a caffeine challenge than the healthy control subjects 2 healthy controls with the1976 TT polymorphism will report increased anxiety after a caffeine challenge compared to healthy controls with the 1976 CT and 1976 CC genotypes New hypotheses 3 panic patients two separate groups currently ill and remitted with the 1976 TT polymorphism will report increased anxiety after a caffeine challenge compared to panic patients with the 1976 CT and 1976 CC genotypes 4 panic patients two separate groups currently ill and remitted with the 1976 TT polymorphism will report increased anxiety after a caffeine challenge compared to healthy controls with the 1976 TT polymorphism will report increased anxiety after a caffeine challenge compared to healthy controls with the 1976 TT genotype
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-M-0183 | None | None | None |