Clinical trial NCT03645096
Conditions: Major Depressive Disorder
Keywords: Depression Pregnenolone Women
Sponsor: University of Texas Southwestern Medical Center
Start date: 2019-09-01; Completion date: 2022-05-31
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Pregnenolone, an over-the-counter supplement, is a naturally occurring neurosteroid made in the adrenal glands and brain. Preclinical research suggests pregnenolone has antidepressant, cognitive enhancing, and neuroprotective properties, particularly in women. The following hypothesis will be tested in this trial: pregnenolone is associated with improvement in depressive symptom severity in women that is associated with changes in the resting state functional connectivity (rsFC) and GABA.

Detailed description:
In this study, 26 adult women meeting criteria for Major Depressive Disorder (MDD) as defined in DSM 5, will be randomized to a double-blind, placebo-controlled, crossover phase I clinical trial of pregnenolone (i.e. each participant receives 500 mg/d, 800 mg/d pregnenolone and placebo in random order). The study will consist of three 7-day treatment exposures to each pregnenolone dose with a 14-day washout between each exposure. Baseline evaluation will include medical and psychiatric history, psychiatric interview, standard laboratory analyses (i.e., blood draw, ECG), and a brief cognitive battery. Neuroimaging will be collected after each study drug or placebo administration. Study drug tolerability and participant safety will be assessed throughout the study (6 in-clinic visits + a safety visit) using structured clinical interviews, self-report questionnaires, and standard laboratory analyses.

Arms: arm 1: 3 exposures in order:

1. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout.
2. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout.
3. Matching placebo capsule by mouth, daily for 7 days. arm 2: 3 exposures in order:

1. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout.
2. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout.
3. Pregnenolone 800 mg capsule by mouth, daily for 7 days. arm 3: 3 exposures in order:

1. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout.
2. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout.
3. Matching placebo capsule by mouth, daily for 7 days. arm 4: 3 exposures in order:

1. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout.
2. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout.
3. Pregnenolone 500 mg capsule by mouth, daily for 7 days. arm 5: 3 exposures in order:

1. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout.
2. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout.
3. Pregnenolone 800 mg capsule by mouth, daily for 7 days. arm 6: 3 exposures in order:

1. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout.
2. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout.
3. Pregnenolone 500 mg capsule by mouth, daily for 7 days.
Interventions: intervention 1: Pregnenolone 500 mg intervention 2: Pregnenolone 800 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Pregnenolone 500 mg capsule. intervention 2: Pregnenolone 800 mg capsule. intervention 3: Placebo capsule manufactured to mimic pregnenolone capsule.

Protocol documents:
Prot_SAP_000.pdf: 


NCT03645096