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Corticosteroid

Hydrocortisone for Memory Impairment

Phase 4

Recruiting

Led By Sherwood Brown, MD, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Baseline QIDS-C between 11-20 (≥ moderate depressive symptoms but < very severe depressive symptoms) for the 'depressed' group

BMI between 18.5-35.0 (neither underweight nor severely obese)

Must not have

History of neurological disorders including seizures, brain surgery, multiple sclerosis, Parkinson's disease

Taking CNS-acting medications (e.g., antidepressants, antipsychotics, lithium, anticonvulsants, sedative/hypnotic/anxiolytics) for the depressed group

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will use hydrocortisone or placebo to study the effects of chronic corticosteroid exposure on memory and the hippocampus in both men and women.

Who is the study for?

This trial is for men and women aged 18-40 with normal to slightly overweight BMI, at least a high school education, and normal memory function. Healthy participants must have minimal depressive symptoms, while the depressed group should have moderate but not severe depression. Participants need good vision (correctable) for MRI tasks.

What is being tested?

The study tests how a short-term high-dose hydrocortisone treatment affects memory and brain structure/function in healthy individuals versus those with depression. It involves taking either hydrocortisone or a placebo pill and undergoing advanced neuroimaging to observe changes in specific areas of the hippocampus.

What are the potential side effects?

Potential side effects from hydrocortisone may include mood swings, increased blood pressure, sleep problems, weight gain around the midsection or face (moon face), increased blood sugar levels, weakened bones over time if used long term.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My depression is moderate to severe, but not very severe.

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My BMI is between 18.5 and 35.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of neurological disorders like seizures or Parkinson's.

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I am taking medication for depression or other mental health conditions.

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I have depression but no other major psychiatric conditions like bipolar or schizophrenia.

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I am allergic to or cannot take hydrocortisone due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hippocampal subfield activation

Hippocampal subfield volume

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Healthy Controls: Placebo, then HydrocortisoneExperimental Treatment2 Interventions

Participants in the "healthy control" arm will receive a Placebo tablet (matching Hydrocortisone 160 mg tablet) every day for 3 days. After a washout period of 25 days, they then will receive a Hydrocortisone 160 mg tablet every day for 3 days.

Group II: Healthy Controls: Hydrocortisone, then PlaceboExperimental Treatment2 Interventions

Participants in the "healthy control" arm will receive a Hydrocortisone 160 mg tablet every day for 3 days. After a washout period of 25 days, they then will receive a Placebo tablet (matching Hydrocortisone 160 mg tablet) every day for 3 days.

Group III: Depressed: Placebo, then HydrocortisoneExperimental Treatment2 Interventions

Participants in the "depressed' arm will receive a Placebo tablet (matching Hydrocortisone 160 mg tablet) every day for 3 days. After a washout period of 25 days, they then will receive a Hydrocortisone 160 mg tablet every day for 3 days.

Group IV: Depressed: Hydrocortisone, then PlaceboExperimental Treatment2 Interventions

Participants in the "depressed' arm will receive a Hydrocortisone 160 mg tablet every day for 3 days. After a washout period of 25 days, they then will receive a Placebo tablet (matching Hydrocortisone 160 mg tablet) every day for 3 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo Oral Tablet

2020

Completed Phase 4

~2490

0 / 6Eligibility criteria met