Status:
WITHDRAWN
Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Post-traumatic Stress Disorder
Major Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00993629
Start Date
January 1 2010
End Date
May 1 2010
Last Update
October 27 2014
Active Locations (1)
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1
VA Medical Center, Durham
Durham, North Carolina, United States, 27705