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Trial record 19 of 107 for:    PHENYTOIN

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
Sponsor:
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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).
Other Names:
  • 5,5-Diphenylhydantoin
  • Fenitoin
  • Antisacer
  • Difenin
  • Dihydan
  • Dilantin
  • Diphenylhydantoin
  • Epamin
  • Hydantol
  • Sodium Diphenylhydantoinate

Drug: Hydrocortisone
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.
Other Names:
  • Cortef
  • Corticosteroids

Drug: Placebo
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hippocampal Activation Differences Between Treatment Conditions [ Time Frame: At the end of each treatment condition ]
  2. Para-Hippocampal Activation Differences Between Treatment Conditions [ Time Frame: At the end of each treatment condition ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-50 years
  • Men or women
  • Vision corrected to at least 20-40
  • No tobacco use
  • Education of ≥12 years (No GED)

Exclusion Criteria:

  • History of major psychiatric illness defined as major depressive disorder, bipolar disorder, post traumatic stress disorder, panic disorder, schizoaffective disorder, schizophrenia or eating disorders
  • History of drug or alcohol abuse or dependence
  • History of neurological disorders including seizures, brain surgery, multiple sclerosis, Parkinson's disease
  • Taking central nervous system (CNS) acting medications (e.g. antidepressants, hypnotics)
  • History of allergic reaction or medical contraindication to phenytoin or hydrocortisone therapy
  • Metal implants, claustrophobia or other contraindications to MRI
  • Significant medical conditions (e.g. myocardial infarction, diabetes)
  • Pregnant or nursing women
  • Prisoners
  • History of mental retardation, special education classes, dementia or other severe cognitive disorders
  • Baseline Hamilton Rating Scale for Depression Score > 7
  • History of a suicide attempt
  • History of systemic corticosteroid use or current inhaled corticosteroid use

Information from the National Library of Medicine

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


Locations
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United States, Texas
UT Southwestern Medical Center of Dallas/Parkland Memorial Hospital
Dallas, Texas, United States, 75390-8849
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Sherwood Brown, M.D.,Ph.D. UT Southwestern Medical Center of Dallas

Additional Information:
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Responsible Party: Sherwood Brown, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00591006     History of Changes
Other Study ID Numbers: 1R21MH078182 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2008    Key Record Dates
Results First Posted: August 19, 2015
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by Sherwood Brown, University of Texas Southwestern Medical Center:
Phenytoin
Dilantin
Corticosteroid
Neuroprotection
Mania
Cognition
Mood
Memory
Hydrocortisone
Healthy Controls
MRI
hippocampal activation

Additional relevant MeSH terms:
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Phenytoin
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Neuroprotective Agents
Anti-Inflammatory Agents
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Protective Agents
Physiological Effects of Drugs