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

NCT00993629 | Withdrawn Phase 2 DMC

• 1 other identifier: B7064-W
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder; Major Depressive Disorder

Keywords

PTSD; Depression; Neurosteroids

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale (CAPS)

  8 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

adjunctive pregnenolone

Drug: pregnenolone

Arm 2

PLACEBO COMPARATOR

adjunctive placebo

Drug: placebo

Interventions

pregnenolone DRUG

Administered adjunctively to "treatment as usual"

Arm 1

placebo DRUG

adjunctive placebo

Arm 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Durham

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Depression

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Victoria M Payne, MD MS

  VA Medical Center, Durham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 12, 2009
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

US (1)