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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans

Conditions
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Post-traumatic Stress Disorder, Major Depressive Disorder

Intervention / Treatment
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* Drug: pregnenolone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>adjunctive pregnenolone | Drug: pregnenolone<br>* Administered adjunctively to treatment as usual<br>|
| Placebo Comparator: Arm 2<br>adjunctive placebo | Drug: placebo<br>* adjunctive placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS) |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Depression, Neurosteroids