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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My depression is moderate to severe, but not very severe.
Select...
My BMI is between 18.5 and 35.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hippocampal subfield activation
Hippocampal subfield volume
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
2017
Completed Phase 4
~2160
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,055 Previous Clinical Trials
1,054,681 Total Patients Enrolled
University of California, IrvineOTHER
546 Previous Clinical Trials
1,923,013 Total Patients Enrolled
1 Trials studying Hydrocortisone
158 Patients Enrolled for Hydrocortisone
National Institute of Mental Health (NIMH)NIH
2,799 Previous Clinical Trials
2,660,976 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either not using estrogen-based birth control, am menopausal, or have irregular periods.You have a history of having problems with drugs or alcohol.My depression is moderate to severe, but not very severe.I have a history of neurological disorders like seizures or Parkinson's.I am between 18-40 years old and my vision, with correction, is at least 20-40.My BMI is between 18.5 and 35.I am taking medication for depression or other mental health conditions.I have depression but no other major psychiatric conditions like bipolar or schizophrenia.You are currently having thoughts about hurting yourself or have tried to hurt yourself in the past year or more than once in your life.I have used corticosteroids for more than 12 weeks in my life or inhaled them in the last 28 days.I have a significant medical condition like cancer, heart disease, or diabetes.I am allergic to or cannot take hydrocortisone due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Depressed: Placebo, then Hydrocortisone
- Group 2: Depressed: Hydrocortisone, then Placebo
- Group 3: Healthy Controls: Hydrocortisone, then Placebo
- Group 4: Healthy Controls: Placebo, then Hydrocortisone
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Hydrocortisone Patient Testimony for trial: Trial Name: NCT03896659 — Phase 4
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