Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes
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|ClinicalTrials.gov Identifier: NCT00591006|
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
The purpose of this research is to determine if patients who receive phenytoin (also commonly known as Dilantin) before taking corticosteroids will show less memory impairment and hypomanic symptoms (feelings of agitation, overexcitement or hyperactivity) than those receiving placebo (an inactive substance). This research also seeks to determine if patients taking phenytoin before corticosteroids show more activity in the area of the brain involved with memory than those receiving placebo.
This research is being done because increased levels of cortisol (the body's natural corticosteroid) in the body are frequently associated with forgetfulness, and interventions that may prevent or reverse this effect are of great importance.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Phenytoin (brand name Dilantin) Drug: Hydrocortisone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Experimental: Four Treatments Per Participant
This study has one arm due to a crossover design. All 17 subjects received 4 treatments: placebo then placebo, phenytoin then placebo, placebo then hydrocortisone, and phenytoin then hydrocortisone. Each treatment was randomly assigned and had a unique sequence out of 24 possible sequences.
Drug: Phenytoin (brand name Dilantin)
Three days prior to imaging, participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total).
Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The doses were selected to achieve a low therapeutic blood level of phenytoin and stress level of cortisol. Newcomer et al. (1999) used this dose of hydrocortisone in healthy controls. The imaging will be performed at approximately 1300 hours.
Participants take two capsules of placebo 100 mg at 0900 hours and 2100 hours for a total of 3 days with the last dose at 0900 hours on the day of imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating placebo), participants will being taking 4 tablets containing placebo (20 mg) also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total).
Other Name: Sugar pill
- Difference in RAVLT Total T-Score Between Treatments [ Time Frame: At end of each treatment condition (on average 21 days between treatments) ]The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions, including short-term auditory-verbal memory, and retention of information. Test raw scores are converted to T-scores. T-scores have a mean of 30 ± 10 where higher scores are indicative of better verbal memory. Total T-score differences following study treatment interventions are reported.
- Hippocampal Activation Differences Between Treatment Conditions [ Time Frame: At the end of each treatment condition ]
- Para-Hippocampal Activation Differences Between Treatment Conditions [ Time Frame: At the end of each treatment condition ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591006
|United States, Texas|
|UT Southwestern Medical Center of Dallas/Parkland Memorial Hospital|
|Dallas, Texas, United States, 75390-8849|
|Principal Investigator:||Sherwood Brown, M.D.,Ph.D.||UT Southwestern Medical Center of Dallas|