Effects of Stress Hormones on Emotion and Cognition
|First Received Date ICMJE||April 3, 2002|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||March 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00032838 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effects of Stress Hormones on Emotion and Cognition|
|Official Title ICMJE||The Effects of Cortisol and Norepinephrine Modulation on Emotional and Nonemotional Processing|
The purpose of this study is to examine how hormonal changes that occur during stressful situations affect thought and emotions. Results from this study may lead to treatments that can alleviate the psychological effects of trauma.
Levels of cortisol and norepinephrine increase in response to stress; these hormones also influence thought processes. This study will give hydrocortisone and/or yohimbine (a stimulator of central norepinephrine) to healthy adults in order to model the stress response and to better understand the way people process information during traumatic events.
This study comprises two experiments in which the stress response is pharmacologically modeled. Participants in the study will have two study visits. During Visit 1, participants will undergo a psychiatric assessment, complete neuropsychological tasks, and have their IQ measured. During Visit 2, participants will be given hydrocortisone and/or yohimbine. Blood will be collected before and during this. Participants will then perform two experiments. In one experiment, participants will hear a story with emotional and non-emotional segments; in a second experiment, participants will view both emotional and non-emotional stimuli.
Memories for traumatic events are fundamentally different from typical memories. Individuals who witness or are involved in an extremely stressful event, such as a robbery or a violent act, retain highly accurate memories for the information directly related to the trauma (e.g., a gun or verbal threat), while surrounding details are poorly remembered. This so-called weapon focus phenomenon has been found in both naturalistic and laboratory studies with humans. However, difficulties with the control of naturalistic studies and approximating trauma in the lab limit the validity of these findings.
Neurophysiologically, cortisol and norepinephrine are principal mediators of the stress response, and both influence memory function. In particular, cortisol improves memory at low levels but impairs memory at higher doses. Similarly, some evidence indicates that norepinephrine also enhances memory in low doses and either impairs or does not influence memory at high doses. Much of the experimental work in this area has been conducted with animals. Studies have recently begun to extend these paradigms to humans.
To better understand memory processing during trauma, hydrocortisone and/or yohimbine (a stimulator of central norepinephrine) will be administered to healthy adults in two experiments in order to pharmacologically model the stress response. Following infusion, participants will hear a story with emotional and nonemotional segments in one experiment (N = 80) and emotional as well as nonemotional stimuli (faces and scenes) in another experiment (N = 80). It is predicted that relative to the placebo, hydrocortisone will impair memory for both emotional and nonemotional information, yohimbine will improve memory for both types of information, and the combination of hydrocortisone and yohimbine will enhance memory for emotional aspects and impair memory for the nonemotional segments of the story. Results from this study will permit a better understanding of how emotionally charged memories are encoded and will potentially lead to treatments to mitigate the psychological effects of traumatic exposure.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Drug: Yohimbine|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||January 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
IQ: all subjects will have IQ greater than 85
Follicular cycle: Women will participate in the encoding task between days 3-10.
Only healthy individuals will participate; special attention will be taken to ensure that no subject has: hypertension, glaucoma, cataracts, ulcers, renal insufficiency, osteoporosis, hypothyroidism, cirrhosis, ocular herpes simplex and myocardial infarction.
Use of hormonal contraception
Use of glucocorticoids within past 3 years
Use of any psychoactive substance; current or past psychiatric diagnosis.
Irregular sleep pattern as defined as getting less than 6 hours of sleep per night, going to sleep after 2:00 AM; waking up before 5:00 AM or after 11:00 AM
Weight that is 15% more or less than ideal body weight for sex and height
History of panic attacks or first degree relative with history of panic attacks
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00032838|
|Other Study ID Numbers ICMJE||020155, 02-M-0155|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP