Back to resultsAdjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
Primary Purpose
Post-traumatic Stress Disorder, Major Depressive Disorder
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pregnenolone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring PTSD, Depression, Neurosteroids
Eligibility 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
Sites / Locations
- VA Medical Center, Durham
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
adjunctive pregnenolone
adjunctive placebo
Outcomes
Primary Outcome Measures
Clinician Administered PTSD Scale (CAPS)
Secondary Outcome Measures
Full Information
NCT ID
NCT00993629
First Posted
October 7, 2009
Last Updated
October 23, 2014
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00993629
Brief Title
Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
Official Title
Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Withdrawn
Why Stopped
PI turned down funding.
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, Major Depressive Disorder
Keywords
PTSD, Depression, Neurosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
adjunctive pregnenolone
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
adjunctive placebo
Intervention Type
Drug
Intervention Name(s)
pregnenolone
Intervention Description
Administered adjunctively to "treatment as usual"
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
adjunctive placebo
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria M Payne, MD MS
Organizational Affiliation
VA Medical Center, Durham
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans
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