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

NCT ID: NCT02837432

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Healthy

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

Group Type OTHER

Hydrocortisone acetate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Depression

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

Group Type OTHER

Hydrocortisone acetate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Hydrocortisone acetate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Cortef

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Keith Sudheimer

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keith Sudheimer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Department of Psychiatry and Behavioral Sciences, 401 Quarry Road

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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19771

Identifier Type: -

Identifier Source: org_study_id