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Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans - NCT00993629-27705(Clinical Trial 368736)



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City:  Durham
State:  
NC
Zip Code: 27705
Conditions: Post-Traumatic Stress Disorder - Major Depressive Disorder
Purpose: 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.
Study summary: 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.
Criteria: 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
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2010
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