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

Primary Purpose

Depression

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hydrocortisone acetate
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring Depression, Cortisol, Sadness, Genetics, Stress

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Psychiatry and Behavioral Sciences, 401 Quarry Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy

Depression

Arm Description

Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order

Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order

Outcomes

Primary Outcome Measures

Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.

Secondary Outcome Measures

Full Information

First Posted
July 15, 2016
Last Updated
October 14, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02837432
Brief Title
The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression
Official Title
The Effect of Cortisol Administration on Neural Correlates of Emotion in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
November 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Cortisol, Sadness, Genetics, Stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
Other
Arm Description
Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order
Arm Title
Depression
Arm Type
Other
Arm Description
Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone acetate
Other Intervention Name(s)
Cortef
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Sudheimer, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Behavioral Sciences, 401 Quarry Road
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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