Trial · NCT00621751

Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression

NCT00621751, Not applicable, Completed, Wake Forest University Health Sciences; results first posted 2021-08-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression. Trials, record NCT00621751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00621751

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Trial

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

Title: Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression
NCT number: NCT00621751
Status: Completed
Phases: Not applicable
Enrollment: 70 participants, actual
Lead sponsor: Wake Forest University Health Sciences
Conditions: Traumatic Brain Injury
Interventions: Carbamazepine, Placebo
First posted: 2008-02-22
Last updated: 2022-04-22
Results first posted: 2021-08-19

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure -- Observer	42 days	Neuropsychiatry Inventory-Irritability (NPI-I) \& Aggression domains (NPI-A): NPI is a 40-item assessment of 12 behavioral domains (NPI-I \& NPI-A domains used in this study). The most problematic aspect of each domain is graded for severity (1=mild, to 3=severe) and frequency (1-4 with 4 representing highest frequency); the domain scores (0-12) are the product of severity and frequency. To best reflect treatment target intent and meet parametric statistical method criteria, the primary outcome was a composite measure of observer-rated NPI-I \& -A domains transformed to a Rasch logit scale running from 0 (best) to 100 (worse) units (i.e., observer-rated NPI-I/A Rasch construct scores). Mean day-42 observer-rated NPI-I/A Rasch construct scores were compared between placebo vs. carbamazepine using ANCOVA with baseline score as covariate.
Secondary	Proportion of Participants With Minimal Clinically Important Difference -- Observer Rating	42-day	Proportion of participants with Minimal Clinically Important Difference (MCID) on Neuropsychiatric Inventory Irritability-Aggression Composite Measure completed by Observer. Specifically, the proportion of participants that experienced a decrease of \> 1 (MCID) in the NPI-I/A Rasch construct score (i.e., participants that are considered to have meaningful reduction in irritability/aggression) from baseline to day-42 between the groups using a chi-square test. MCID was defined as 0.5 times the standard deviation of baseline scores.
Secondary	Global Impression of Change -- Observer	42 days	Global Impression of Change (GIC) is a 5-item Likert Scale rated participants and observer impression of change in the person with TBI. Responses range 1 = much improved to 5 = much worse.
Secondary	Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure Completed by Participant [Time Frame: 42 Days]	Day 42	Neuropsychiatry Inventory-Irritability (NPI-I) \& Aggression domains (NPI-A): NPI is a 40-item assessment of 12 behavioral domains (NPI-I \& NPI-A domains used in this study). The most problematic aspect of each domain is graded for severity (1=mild, to 3=severe) and frequency (1-4 with 4 representing highest frequency); the domain scores (0-12) are the product of severity and frequency. To best reflect treatment target intent and meet parametric statistical method criteria, a composite measure of participant-rated NPI-I \& -A domains transformed to a Rasch logit scale running from 0 (best) to 100 (worse) units (i.e., participant-rated NPI-I/A Rasch construct scores). Mean day-42 participant-rated NPI-I/A Rasch construct scores were compared between placebo vs. CBZ using ANCOVA with baseline score as covariate.
Secondary	Proportion of Participants With Minimal Clinically Important Difference (MCID) -- Participant	Day-42	Proportion of participants with Minimal Clinically Important Difference (MCID) on Neuropsychiatric Inventory Irritability-Aggression Composite Measure completed by Participant. Specifically, the proportion of participants that experienced a decrease of \> 1 (MCID) in the NPI-I/A Rasch construct score (i.e., participants that are considered to have meaningful reduction in irritability/aggression) from baseline to day-42 between the groups using a chi-square test. MCID was defined as 0.5 times the standard deviation of baseline scores.
Secondary	Clinicians Global Impression of Change	42 days	Study physician's impression of change since study onset. Clinicians Global Impressions of Change (CGI) is a sensitive, standardized tool to assess psychopharmacologic treatment response completed by the study physician. The Global Improvement (GI) CGI subscale documented the clinician's impression of change. The GI uses a 7-point scale to assess beneficial and negative effects. Low GI values (1 -3) indicate improvement; higher values (4-7) represent worsening.
Secondary	Global Impression of Change -- Participant	Day-42	Global Impression of Change (GIC) is a 5-item Likert Scale rated participants and observer impression of change in the person with TBI. Responses range 1 = much improved to 5 = much worse.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure -- Observer	42 days		score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Participants With Minimal Clinically Important Difference -- Observer Rating	42-day		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Global Impression of Change -- Observer	42 days		units on a scale	MEAN
SECONDARY	Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure Completed by Participant [Time Frame: 42 Days]	Day 42	There were fewer participants scores than observers scores.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Participants With Minimal Clinically Important Difference (MCID) -- Participant	Day-42		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinicians Global Impression of Change	42 days		units on a scale	MEAN
SECONDARY	Global Impression of Change -- Participant	Day-42		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Spread	Units
Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure -- Observer	Carbamazepine	37.7	Standard Error 1.4	score on a scale
Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure -- Observer	Placebo	36.7	Standard Error 1.5	score on a scale
Proportion of Participants With Minimal Clinically Important Difference -- Observer Rating	Carbamazepine	20		Participants
Proportion of Participants With Minimal Clinically Important Difference -- Observer Rating	Placebo	26		Participants
Global Impression of Change -- Observer	Carbamazepine	3.3	Standard Deviation 1.4	units on a scale
Global Impression of Change -- Observer	Placebo	3.1	Standard Deviation 0.9	units on a scale
Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure Completed by Participant [Time Frame: 42 Days]	Carbamazepine	37.5	Standard Error 1.4	score on a scale
Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure Completed by Participant [Time Frame: 42 Days]	Placebo	36.4	Standard Error 1.4	score on a scale
Proportion of Participants With Minimal Clinically Important Difference (MCID) -- Participant	Carbamazepine	21		Participants
Proportion of Participants With Minimal Clinically Important Difference (MCID) -- Participant	Placebo	16		Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Carbamazepine	35
Overall Study	STARTED	Placebo	35
Overall Study	COMPLETED	Carbamazepine	35
Overall Study	COMPLETED	Placebo	34
Overall Study	NOT COMPLETED	Carbamazepine	0
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events40

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
other	Cardiac disprders	Cardiac disorders	Carbamazepine	2	35	2
other	Cardiac disprders	Cardiac disorders	Placebo	0	35	0
other	Gastrointestinal disorders	Gastrointestinal disorders	Carbamazepine	5	35	5
other	Gastrointestinal disorders	Gastrointestinal disorders	Placebo	2	35	2
other	General disorders & administration conditions	General disorders	Carbamazepine	3	35	3
other	General disorders & administration conditions	General disorders	Placebo	1	35	1
other	Injury	Injury, poisoning and procedural complications	Carbamazepine	2	35	2
other	Injury	Injury, poisoning and procedural complications	Placebo	0	35	0
other	Lab results	Investigations	Carbamazepine	3	35	3
other	Lab results	Investigations	Placebo	0	35	0

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Carbamazepine	0	35
Total, all-cause mortality	Placebo	0	35
Total, other adverse events	Carbamazepine	29	35
Total, other adverse events	Placebo	19	35
Total, serious adverse events	Carbamazepine	6	35
Total, serious adverse events	Placebo	1	35

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1521112	BACKGROUND	PubMed
8845710	BACKGROUND	PubMed
9012550	BACKGROUND	PubMed
10576463	BACKGROUND	PubMed

Grants0

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.

None in this release.

Trial comparisons4

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

Comparison	Source
Carbamazepine vs Placebo: Proportion of Participants With Minimal Clinically Important Difference -- Observer Rating	Trial comparisons
Carbamazepine vs Placebo: Proportion of Participants With Minimal Clinically Important Difference (MCID) -- Participant	Trial comparisons
Carbamazepine vs Placebo: deaths from any cause	Trial comparisons
Carbamazepine vs Placebo: serious adverse events	Trial comparisons

Tests0

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

None in this release.

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.

GET https://conductscience.org/api/trials/v1/NCT00621751

GET https://conductscience.org/api/trials/v1/NCT00621751/events?page=2

API reference For AI assistants