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

US Department of Veterans Affairs (VA)

Status and phase: Withdrawn; Phase 2

Conditions: Major Depressive Disorder; Post-traumatic Stress Disorder

Treatments: Drug: placebo; Drug: pregnenolone

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00993629

B7064-W

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

adjunctive pregnenolone

Treatment:

Drug: pregnenolone

Arm 2

Placebo Comparator group

Description:

adjunctive placebo

Treatment:

Drug: placebo