← Back to Search

Neuroactive Steroid

Pregnenolone for Depression in HIV (SOOTHE Trial)

Phase 2
Recruiting
Led By Shibani S. Mukerji, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, day 14, day 28, day 56
Awards & highlights

SOOTHE Trial Summary

This trial will test if pregnenolone can help people living with HIV who have depression, by improving brain functioning, reducing inflammation, and decreasing depressive symptoms. Participants will receive pills and have their brain and behavior assessed.

Who is the study for?
This trial is for adults aged 18-70 with HIV who are on antiretroviral therapy and have depression (CES-D score ≥ 20). They must not be pregnant, severely cognitively impaired, or using certain medications like cobicistat. People with recent severe infections, liver inflammation, severe renal disease, high blood pressure, or a history of bipolar disorder or schizophrenia cannot join.Check my eligibility
What is being tested?
The study tests if pregnenolone can improve brain function and reduce depressive symptoms in people with HIV. Participants will receive either pregnenolone or a placebo pill while continuing their current antidepressants. Brain scans and behavioral assessments will monitor changes.See study design
What are the potential side effects?
Pregnenolone may cause side effects such as hormonal imbalances since it's involved in steroid hormone production. However, specific side effects aren't listed; participants should report any new symptoms to the study team.

SOOTHE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 14, day 28, day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, day 14, day 28, day 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gamma-aminobutyric acid
Secondary outcome measures
Adverse Events
CD14+CD16+ Monocytes
Center for Epidemiological Studies-Depression (CES-D; scores range from 0 (no symptoms) to 60 (maximum severity of depressive symptoms))
+2 more

SOOTHE Trial Design

2Treatment groups
Experimental Treatment
Group I: PregnenoloneExperimental Treatment1 Intervention
Participants will be on the following dosage schedule: 50 mg daily for 2 weeks, THEN 100 mg daily for 1 week, THEN 250 mg daily for 1 week, THEN 500 mg daily for 4 weeks
Group II: PlaceboExperimental Treatment1 Intervention
Participants will be on the following dosage schedule: 50 mg daily for 2 weeks, THEN 100 mg daily for 1 week, THEN 250 mg daily for 1 week, THEN 500 mg daily for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Pregnenolone
2011
Completed Phase 4
~770

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,361 Total Patients Enrolled
Institute for Medical Research, Inc.Industry Sponsor
1 Previous Clinical Trials
144 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,647 Total Patients Enrolled

Media Library

Pregnenolone (Neuroactive Steroid) Clinical Trial Eligibility Overview. Trial Name: NCT05570812 — Phase 2
Depression and Anxiety Research Study Groups: Pregnenolone, Placebo
Depression and Anxiety Clinical Trial 2023: Pregnenolone Highlights & Side Effects. Trial Name: NCT05570812 — Phase 2
Pregnenolone (Neuroactive Steroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05570812 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you accept volunteers aged sixty or over for this research?

"To be admitted to this medical study, patients must lie between 18 and 70 years old. There are 222 trials for those under the legal age of consent, and 1073 studies available for seniors over 65 years old."

Answered by AI

Has the FDA sanctioned Pregnenolone for public consumption?

"Our internal rating system at Power assigns Pregnenolone a score of 2, signifying that there is some evidence to its safety while efficacy has yet to be adequately established."

Answered by AI

How many individuals are being recruited to participate in this research?

"Affirmative. Data posted on clinicaltrials.gov confirms that this medical research is actively recruiting patients, with an initial posting date of February 1st 2023 and a recent update from the 15th of February. The study requires 120 participants to be sourced from one site."

Answered by AI

Are there any available vacancies in this clinical experiment?

"Affirmative. According to the clinical trials website, this research project is presently looking for volunteers and was first posted on February 1st 2023 with a recent update from February 15th of that same year. The study requires 120 participants at just one location."

Answered by AI

Who meets the eligibility requirements to join this clinical research?

"The scope of this study consists of 120 individuals suffering from depression and anxiety that meet the following criteria: HIV-1 viral load <200 copies/mL on antiretroviral therapy, Center for Epidemiological Studies - Depression (CES-D) score ≥ 20, aged between 18 to 70 years."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
Shibani Mukerji 2023. "Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05570812.
All > Depression Boston
~80 spots leftby Sep 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top