Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans

Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00993629

Enrollment

Registered

2009-10-12

Start date

2010-01-31

Completion date

2010-05-31

Last updated

2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder, Post-traumatic Stress Disorder

Keywords

PTSD, Depression, Neurosteroids

Brief summary

This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.

Detailed description

PTSD and depression are critical areas of immediate impact to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) Veterans. Current treatments for PTSD (which frequently co-occurs with depression) remain limited, with many patients remaining symptomatic despite single or combination administration of SSRIs, mood stabilizers, antipsychotics and sedatives/hypnotics. In addition, many patients treated for depression remain symptomatic. New interventions are thus urgently needed in PTSD with co-occurring depression to ensure optimal functional outcomes for our Service members and their families.

Interventions

DRUGpregnenolone

Administered adjunctively to treatment as usual

DRUGplacebo

adjunctive placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Diagnosis of PTSD, * diagnosis of MDD, * age 18-55, * no change in psychotropic medication for \>=4 weeks, * no anticipated need to to alter psychotropic medication for duration of study

Exclusion criteria

* Unstable medical/neurological illness, * diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, * cognitive disorder, * substance dependence, * positive urine drug screen at screening, * use of hormonal supplementation, * pregnancy/lactation, * female patients who are sexually active and not using acceptable non-hormonal birth control, * initiation/change of psychotherapy within 3 months of randomization, * recent/current electroconvulsive therapy, * regular use of opiates/barbiturates/benzodiazepines

Design outcomes

Primary

Measure	Time frame
Clinician Administered PTSD Scale (CAPS)	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026