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

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0, day 14, day 28, day 56

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

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

Primary study objectives

Gamma-aminobutyric acid

Secondary study objectives

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

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