HealthyNCT00032838
Effects of Stress Hormones on Emotion and Cognition
An observational study of Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Yohimbine
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Jan 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age: 18-36
- IQ: all subjects will have IQ greater than 85
- Follicular cycle: Women will participate in the encoding task between days 3-10.
Who cannot join
- Pregnancy/Nursing
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Yohimbine
- Keywords
- Hydrocortisone, Yohimbine, Cognition, Norepinephrine, Cortisol, Emotion, Healthy Volunteer, HV, Normal Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YohimbineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2002 (estimated)
- Study startMar 2002
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 170 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032838
- Sponsor's protocol ID
- 020155
- Other IDs
- 02-M-0155
- Status last verified
- Jan 2006
- First submitted
- 3 Apr 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Diamond DM, Fleshner M, Ingersoll N, Rose GM. Psychological stress impairs spatial working memory: relevance to electrophysiological studies of hippocampal function. Behav Neurosci. 1996 Aug;110(4):661-72. doi: 10.1037//0735-7044.110.4.661.
PubMed 8864259Sandi C, Loscertales M, Guaza C. Experience-dependent facilitating effect of corticosterone on spatial memory formation in the water maze. Eur J Neurosci. 1997 Apr;9(4):637-42. doi: 10.1111/j.1460-9568.1997.tb01412.x.
PubMed 9153570Christianson SA, Fallman L. The role of age on reactivity and memory for emotional pictures. Scand J Psychol. 1990;31(4):291-301. doi: 10.1111/j.1467-9450.1990.tb00841.x.
PubMed 2274761
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cortisol and Norepinephrine Modulation on Emotional and Nonemotional Processing
- ClinicalTrials.gov ID
- NCT00032838
- Acronym / sponsor ID
- 020155
- Conditions
- Healthy
- Keywords
- Hydrocortisone, Yohimbine, Cognition, Norepinephrine, Cortisol, Emotion, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Mar 2002
- Study completion
- Jan 2006
- First posted
- 4 Apr 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-36
- IQ: all subjects will have IQ greater than 85
- Follicular cycle: Women will participate in the encoding task between days 3-10.
Key exclusion criteria (8 listed)
- Pregnancy/Nursing
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yohimbine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8864259Diamond DM, Fleshner M, Ingersoll N, Rose GM. Psychological stress impairs spatial working memory: relevance to electrophysiological studies of hippocampal function. Behav Neurosci. 1996 Aug;110(4):661-72. doi: 10.1037//0735-7044.110.4.661.
- Background: PubMed 9153570Sandi C, Loscertales M, Guaza C. Experience-dependent facilitating effect of corticosterone on spatial memory formation in the water maze. Eur J Neurosci. 1997 Apr;9(4):637-42. doi: 10.1111/j.1460-9568.1997.tb01412.x.
- Background: PubMed 2274761Christianson SA, Fallman L. The role of age on reactivity and memory for emotional pictures. Scand J Psychol. 1990;31(4):291-301. doi: 10.1111/j.1467-9450.1990.tb00841.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00032838, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.