- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00993629
Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
October 23, 2014 updated by: US Department of Veterans Affairs
Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans
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 Overview
Status
Withdrawn
Intervention / Treatment
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 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.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- VA Medical Center, Durham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1
adjunctive pregnenolone
|
Administered adjunctively to "treatment as usual"
|
Placebo Comparator: Arm 2
adjunctive placebo
|
adjunctive placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinician Administered PTSD Scale (CAPS)
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Victoria M Payne, MD MS, VA Medical Center, Durham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
October 7, 2009
First Submitted That Met QC Criteria
October 9, 2009
First Posted (Estimate)
October 12, 2009
Study Record Updates
Last Update Posted (Estimate)
October 27, 2014
Last Update Submitted That Met QC Criteria
October 23, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B7064-W
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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