The Effect of Cortisol Administration on Neural Correlate... | NCT02837432

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

NCT02837432

Sponsor

Stanford University

Status

Completed

Last Update Posted

Oct 22, 2021Actual

Enrollment

192Actual

Phase

Early Phase 1

Conditions

Depression

Interventions

Hydrocortisone acetate
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Dec 13, 2019Actual

Completion Date

Nov 15, 2020Actual

First Submitted Date

Jul 15, 2016

First Submission Date that Met QC Criteria

Jul 18, 2016

First Posted Date

Jul 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2021

Last Update Posted Date

Oct 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

192Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy	Other	Healthy individuals will receive both the placebo and hydrocortisone interventions in a randomized order	Drug: Hydrocortisone acetate Drug: Placebo
Depression	Other	Individuals with depression will receive both the placebo and hydrocortisone interventions in a randomized order	Drug: Hydrocortisone acetate Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrocortisone acetate	Drug		Depression Healthy	Cortef
Placebo

Measure	Description	Time Frame
Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging.		2 hours

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keith Sudheimer, Ph.D.	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry and Behavioral Sciences, 401 Quarry Road		Stanford	California	94305	United States

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
C021650	hydrocortisone acetate
D006854	Hydrocortisone

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473