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The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837432
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Keith Sudheimer, Stanford University

Study Description
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Brief Summary:
There is good evidence to suggest that the pathological version of sadness that people with Major Depression experience could be caused by the failure of the hormone cortisol to properly inhibit sadness-related brain activity in the subgenual cingulate cortex. This project investigates if the subgenual cingulate cortex has become insensitive to cortisol in patients with depression and tests for variants of the cortisol receptor genes that could predispose individuals to develop cortisol insensitivity.

Condition or disease Intervention/treatment Phase
Depression Drug: Hydrocortisone acetate Drug: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Healthy
Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order
 Drug: Hydrocortisone acetate
Other Name: Cortef

Drug: Placebo
Depression
Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order
 Drug: Hydrocortisone acetate
Other Name: Cortef

Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging. [ Time Frame: 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

https://redcap.stanford.edu/surveys/?s=3F7WCENPND

Inclusion Criteria:

  • Healthy Participants must have no Axis 1 mental disorder
  • Participants with depression must meet minimum severity levels (Hamilton >7)
  • All participants must weight less than 280 pounds for the purposes of MRI scanning

Exclusion Criteria:

In order to protect against risk associated with taking Hydrocortisone, all participants must not have any of the following:

  • Psychotropic medications
  • Recent surgery
  • Endocrine disorders
  • Liver disease
  • Kidney disease
  • Thyroid disorder
  • History of malaria
  • Tuberculosis
  • Osteoporosis
  • Glaucoma/cataracts
  • Chronic expressed infections (herpes --including ocular herpes, HIV, etc.)
  • History of congestive heart failure
  • History of recurring seizures
  • Stomach Ulcers
  • Comorbid psychosis
  • Current use of illicit drugs
  • High Blood pressure

In order to protect against risks associated with MRI scanning participants must not be/have any of the following:

  • >280 lbs
  • In-dwelling ferrous metals
  • Left Handed
  • Abnormal Hearing
  • Claustrophobic
  • Head injury with loss of consciousness
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837432


Contacts
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Contact: Dalton D Duvio (650)498-5904 dlduvio@alumni.stanford.edu
Contact: David James (650)498-5904 david.james@stanford.edu

Locations
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United States, California
Department of Psychiatry and Behavioral Sciences, 401 Quarry Road Recruiting
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
More Information
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Responsible Party: Keith Sudheimer, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02837432    
Other Study ID Numbers: 19771
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Keith Sudheimer, Stanford University:
Depression
Cortisol
Sadness
Genetics
Stress
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents