Adjunctive Pregnenolone in Veterans With Mild TBI
|ClinicalTrials.gov Identifier: NCT00623506|
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : June 20, 2013
Last Update Posted : June 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Drug: Pregnenolone Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Adjunctive Pregnenolone in Veterans With Mild TBI|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||November 2012|
Active Comparator: 1
Placebo for two weeks (during placebo lead-in), then:
Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID)
Placebo Comparator: 2
Placebo for two weeks (placebo lead in), then:
Placebo equivalent to Pregnenolone arm: 100 mg in divided doses (50 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 300 mg in divided doses (150 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 500 mg in divided doses (250 mg, PO, BID)
- Brief Assessment of Cognition in Affective Disorders (BAC-A) [ Time Frame: Week 2, Week 10 ]Mean change scores (Week 2 minus Week 10) to assess cognitive changes. The BAC-A includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 10 (Week 2 minus Week 10).
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: Week 2, Week 10 ]
Mean change scores (Week 2 minus Week 10) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered).
A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
- Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: Week 2, Week 10 ]The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability,sleep,weight/appetite change,and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623506
|United States, North Carolina|
|Durham VA Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Christine E Marx, MD, MA||Durham VAMC|