Adjunctive Pregnenolone in Veterans With Mild TBI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00623506
First received: February 15, 2008
Last updated: May 13, 2013
Last verified: May 2013
Results First Received: March 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Traumatic Brain Injury
Interventions: Drug: Pregnenolone
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Durham Medical Center, Durham, NC.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Each subject received a two week placebo-lead in following enrollment.

Reporting Groups
  Description
Pregnenolone

Pregnenolone

Pregnenolone : 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

Placebo

Subjects received placebo study medication; dispensed exactly as active study medication was dispensed.


Participant Flow:   Overall Study
    Pregnenolone     Placebo  
STARTED     15     15  
Week 4     11     11  
COMPLETED     11     11  
NOT COMPLETED     4     4  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pregnenolone

Pregnenolone

Pregnenolone : 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

Placebo

Subjects received placebo study medication; dispensed exactly as active study medication was dispensed.

Total Total of all reporting groups

Baseline Measures
    Pregnenolone     Placebo     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     11     22  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.27  ± 10.51     36.38  ± 9.74     35.76  ± 9.97  
Gender  
[units: participants]
     
Female     2     1     3  
Male     9     10     19  
Region of Enrollment  
[units: participants]
     
United States     11     11     22  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Brief Assessment of Cognition in Affective Disorders (BAC-A)   [ Time Frame: Week 2, Week 10 ]

2.  Secondary:   Clinician Administered PTSD Scale (CAPS)   [ Time Frame: Week 2, Week 10 ]

3.  Secondary:   Quick Inventory of Depressive Symptomatology (QIDS)   [ Time Frame: Week 2, Week 10 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Christine E. Marx, MD
Organization: Durham VA Medical Center
phone: 919 286-0411 ext 7426
e-mail: marx0001@mc.duke.edu


No publications provided


Responsible Party: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT00623506     History of Changes
Other Study ID Numbers: VA IRB# 01209, VA IRB# 01209
Study First Received: February 15, 2008
Results First Received: March 5, 2013
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government