Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044096
Status:
COMPLETED
Last Update Posted:
2018-07-05
First Post:
2002-08-16
Brief Title:
Psychopharmacology of Fear-Potentiated Startle in Humans
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Psychopharmacology of Fear-Potentiated Startle in Humans
Status:
COMPLETED
Status Verified Date:
2013-09-17
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:
The purpose of this study is to understand the effects of the drug alprazolam Xanax on anxiety
To understand the effect of anxiety-relieving drugs on fear and anxiety researchers often have participants anticipate unpleasant stimuli Anticipating unpleasant stimuli increases or potentiates a simple reflex called the startle reflex The so-called fear-potentiated startle reflex FPS effect may be blocked or reduced by anxiety-relieving drugs Evidence suggests that the FPS can be mediated by two mechanisms that regulate the phasic- and sustained enhancement of startle This study will elicit phasic and sustained FPS in participants by having them anticipate moderately painful stimuli that are administered predictably and unpredictably The main goal of this study is to assess the affect of alprazolam on the phasic and sustained enhancement of startle
This study comprises two pilot experiments and a main study Participants in the study will be screened with a psychiatric history physical examination electrocardiogram EKG and blood and urine tests Participants will four testing sessions separated by 5 to 10 days At each session participants will be given one of two doses of alprazolam diphenhydramine or placebo an inactive pill Questionnaires and other tests will be performed
To understand the effect of anxiety-relieving drugs on fear and anxiety researchers often have participants anticipate unpleasant stimuli Anticipating unpleasant stimuli increases or potentiates a simple reflex called the startle reflex The so-called fear-potentiated startle reflex FPS effect may be blocked or reduced by anxiety-relieving drugs Evidence suggests that the FPS can be mediated by two mechanisms that regulate the phasic- and sustained enhancement of startle This study will elicit phasic and sustained FPS in participants by having them anticipate moderately painful stimuli that are administered predictably and unpredictably The main goal of this study is to assess the affect of alprazolam on the phasic and sustained enhancement of startle
This study comprises two pilot experiments and a main study Participants in the study will be screened with a psychiatric history physical examination electrocardiogram EKG and blood and urine tests Participants will four testing sessions separated by 5 to 10 days At each session participants will be given one of two doses of alprazolam diphenhydramine or placebo an inactive pill Questionnaires and other tests will be performed
Detailed Description:
Objective
Recent breakthroughs in biomedical research have not improved the ability to identify successful pharmacological treatments derived from novel candidate compounds This is partly due to the inability of the existing scientific approach to translate candidate anxiolytics identified through the drug discovery process into efficient psychopharmacological treatment of patients A new drug development approach urgently needs to be implemented to improve predictability and efficiency in translating the basic science explosion into validated drug targets A key approach to improve the selection of candidate anxiolytics for clinical trials is to fill the gap between animal models and clinical studies in patients by implementing tests in healthy humans with a predictive validity of subsequent clinical efficacy As a step towards this goal we developed integrative experimental models of fear and anxiety in non-clinical subjects We now use these models to identify the anxiolytic and anxiogenic properties of various compounds The current specific objectives are to 1 further test the psychopharmacological validity of the model using recognized anxiolytics the SSRI citalopram 2 test the properties of compounds that are hypothesized to be anxiolytic or anxiogenic eg oxytocin arginine vasopressin hydrocortisone and 3 examine the time course of the anxiolytic effect of the benzodiazepine alprazolam on FPS
Study population
Medically and psychiatrically healthy males and females ages 18 to 45
Design
The study examines fear and anxiety elicited by unpleasant electric shock delivered predictably and unpredictably respectively The following drugs will be tested
1 Citalopram 2 oxytocin and arginine vasopressin 3 hydrocortisone 4 alprazolam
Outcome measures
The primary outcome measure is the startle reflex Secondary measures include the skin conductance response the heart rate and subjective measures of anxiety
Recent breakthroughs in biomedical research have not improved the ability to identify successful pharmacological treatments derived from novel candidate compounds This is partly due to the inability of the existing scientific approach to translate candidate anxiolytics identified through the drug discovery process into efficient psychopharmacological treatment of patients A new drug development approach urgently needs to be implemented to improve predictability and efficiency in translating the basic science explosion into validated drug targets A key approach to improve the selection of candidate anxiolytics for clinical trials is to fill the gap between animal models and clinical studies in patients by implementing tests in healthy humans with a predictive validity of subsequent clinical efficacy As a step towards this goal we developed integrative experimental models of fear and anxiety in non-clinical subjects We now use these models to identify the anxiolytic and anxiogenic properties of various compounds The current specific objectives are to 1 further test the psychopharmacological validity of the model using recognized anxiolytics the SSRI citalopram 2 test the properties of compounds that are hypothesized to be anxiolytic or anxiogenic eg oxytocin arginine vasopressin hydrocortisone and 3 examine the time course of the anxiolytic effect of the benzodiazepine alprazolam on FPS
Study population
Medically and psychiatrically healthy males and females ages 18 to 45
Design
The study examines fear and anxiety elicited by unpleasant electric shock delivered predictably and unpredictably respectively The following drugs will be tested
1 Citalopram 2 oxytocin and arginine vasopressin 3 hydrocortisone 4 alprazolam
Outcome measures
The primary outcome measure is the startle reflex Secondary measures include the skin conductance response the heart rate and subjective measures of anxiety
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 |
|---|---|---|---|
| 02-M-0263 | None | None | None |