Trial · NCT00591006

Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes

NCT00591006, Phase 3, Completed, University of Texas Southwestern Medical Center; results first posted 2015-08-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes. Trials, record NCT00591006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00591006

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes
NCT number: NCT00591006
Status: Completed
Phases: Phase 3
Enrollment: 17 participants, actual
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Healthy
Interventions: Phenytoin (brand name Dilantin), Hydrocortisone, Placebo
First posted: 2008-01-11
Last updated: 2015-08-19
Results first posted: 2015-08-19
Limitations and caveats: The sample size in this pilot study was modest; The duration of exposure to hydrocortisone was subacute;

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Difference in RAVLT Total T-Score Between Treatments	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	Hippocampal Activation Differences Between Treatment Conditions	At the end of each treatment condition
Secondary	Para-Hippocampal Activation Differences Between Treatment Conditions	At the end of each treatment condition

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Difference in RAVLT Total T-Score Between Treatments	At end of each treatment condition (on average 21 days between treatments)	T-score	MEAN
SECONDARY	Hippocampal Activation Differences Between Treatment Conditions	At the end of each treatment condition	percentage of BOLD activation	MEAN
SECONDARY	Para-Hippocampal Activation Differences Between Treatment Conditions	At the end of each treatment condition	percentage of BOLD activation	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Difference in RAVLT Total T-Score Between Treatments	Phenytoin&Hydrocortisone	57.76	Standard Error 0.51	T-score
Difference in RAVLT Total T-Score Between Treatments	Placebo&Placebo	56.11	Standard Error 0.67	T-score
Difference in RAVLT Total T-Score Between Treatments	Phenytoin&Placebo	53.08	Standard Error 0.45	T-score
Difference in RAVLT Total T-Score Between Treatments	Placebo&Hydrocortisone	42.76	Standard Error 2.60	T-score
Hippocampal Activation Differences Between Treatment Conditions	Phenytoin&Hydrocortisone	1.035	Standard Deviation 0.180	percentage of BOLD activation
Hippocampal Activation Differences Between Treatment Conditions	PBO&PBO	1.288	Standard Deviation .06	percentage of BOLD activation
Hippocampal Activation Differences Between Treatment Conditions	Phenytoin&PBO	1.135	Standard Deviation 0.161	percentage of BOLD activation
Hippocampal Activation Differences Between Treatment Conditions	PBO&Hydrocortisone	1.121	Standard Deviation 0.144	percentage of BOLD activation
Para-Hippocampal Activation Differences Between Treatment Conditions	Phenytoin&Hydrocortisone	1.293	Standard Deviation 0.264	percentage of BOLD activation
Para-Hippocampal Activation Differences Between Treatment Conditions	PBO&PBO	1.604	Standard Deviation 0.315	percentage of BOLD activation

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow144

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PH + PL Then PL + H Then PL + H Then PL + PL	1
Overall Study	STARTED	PH + H Then PH + PL Then PL + H Then PL + PL	0
Overall Study	STARTED	PL + PL Then PH + PL Then PH + H Then PL + H	1
Overall Study	STARTED	PL + H Then PL + PL Then PH + PL Then PH + H	1
Overall Study	STARTED	PL + H Then PH + PL Then PL + PL Then PH + H	1
Overall Study	STARTED	PL + H Then PL + PL Then PH + H Then PH + PL	0
Overall Study	STARTED	PL + H Then PH +H Then PH + PL Then PL + PL	1
Overall Study	STARTED	PL + H Then PH + H Then PL + PL Then PH + PL	0
Overall Study	STARTED	PL + H Then PH + PL Then PH + H Then PL + PL	1
Overall Study	STARTED	PH + H Then PL + H Then PL + PL Then PH + PL	1

1 to 10 of 144Source ClinicalTrials.gov

See all 144 participant flow

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	MRI anxiety	General disorders	Phenytoin, Then Hydrocortisone	0	16	0
serious	MRI anxiety	General disorders	Phenytoin, Then Placebo	0	16	0
serious	MRI anxiety	General disorders	Placebo, Then Hydrocortisone	1	14	1
serious	MRI anxiety	General disorders	Placebo, Then Placebo	0	15	0
serious	Pre-existing condition discovered during MRI	Nervous system disorders	Phenytoin, Then Hydrocortisone	1	16	1
serious	Pre-existing condition discovered during MRI	Nervous system disorders	Phenytoin, Then Placebo	0	16	0
serious	Pre-existing condition discovered during MRI	Nervous system disorders	Placebo, Then Hydrocortisone	0	14	0
serious	Pre-existing condition discovered during MRI	Nervous system disorders	Placebo, Then Placebo	0	15	0

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phenytoin, Then Hydrocortisone
Total, all-cause mortality	Phenytoin, Then Placebo
Total, all-cause mortality	Placebo, Then Hydrocortisone
Total, all-cause mortality	Placebo, Then Placebo
Total, other adverse events	Phenytoin, Then Hydrocortisone	0	16
Total, other adverse events	Phenytoin, Then Placebo	0	16
Total, other adverse events	Placebo, Then Hydrocortisone	0	14
Total, other adverse events	Placebo, Then Placebo	0	15
Total, serious adverse events	Phenytoin, Then Hydrocortisone	1	16
Total, serious adverse events	Phenytoin, Then Placebo	0	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21MH078182	Development of a Model to Examine Corticosteroid Effects on the Hippocampus	BROWN, E SHERWOOD	UT SOUTHWESTERN MEDICAL CENTER	NATIONAL INSTITUTE OF MENTAL HEALTH	2008 to 2009

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Verbal Learning	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT00591006/flow?page=2

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