Trial intelligence / Profile preview

Pregnenolone for Anxiety and Depression in Veterans

NCT06188923Phase 2

Key facts

Status
Recruiting
Start
Aug 2025
Primary completion
Jun 2028
Countries
1
Sponsor
VA Office of Research & Development
Modality
Small Molecules
Conditions
anxiety disordermajor depressive disorder (MDD)
01

Overview

Phase 2, randomised, double-blind trial in anxiety disorder and major depressive disorder (MDD) comparing Pregnenolone with Placebo (2 arms). Primary endpoint: World Health Organization Disability Assessment Schedule II at 10 weeks. Started Aug 2025; status: recruiting.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Pregnenolone

    Pregnenolone flexible dosing for 8 weeks

  • Placebo

    Placebo for 8 weeks

03

Who it enrols

Veterans with moderate to severe anxiety and depression symptoms (PHQ-ADS >= 20), excluding those with severe PTSD, bipolar disorder, schizophrenia, current suicidal ideation, or recent substance use disorders.

04

Endpoints

Primary

  • World Health Organization Disability Assessment Schedule II

Secondary

  • Patient Health Questionnaire Anxiety and Depression Scale

  • Brief Pain Inventory, Second Edition

  • Pittsburgh Sleep Quality Index

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