Trial · NCT00779324
Amantadine for the Treatment of Traumatic Brain Injury Irritability and Aggression: A Multi-site Study
NCT00779324, Not applicable, Completed, Wake Forest University Health Sciences; results first posted 2021-09-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Amantadine for the Treatment of Traumatic Brain Injury Irritability and Aggression: A Multi-site Study. Trials, record NCT00779324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00779324
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Amantadine for the Treatment of Traumatic Brain Injury Irritability and Aggression: A Multi-site Study
- NCT number
- NCT00779324
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 168 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Brain Injury, Aggression
- Interventions
- Amantadine Hydrochloride, Placebo
- First posted
- 2008-10-24
- Last updated
- 2022-07-12
- Results first posted
- 2021-09-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Observer Day 28 | Day 28 | The Neuropsychiatric Inventory (NPI) is a 40-item rating scale developed to assess 12 behavioral domains. Only the NPI-Irritability (NPI-I) domain was used for this study. NPI-I measures irritability with items including: bad temper, rapid mood changes, sudden anger, impatience, crankiness, argumentative. The rater selects the frequency (1-3) and severity (1-4) of the most problematic of these behavioral aspect(s) over the preceding month. The NPI score is the product of the frequency and severity for the NPI most problematic item score. The primary outcome measure was the proportion of participants with greater than two-point increase on the Neuropsychiatric Inventory Irritability domain. The total range is 1 (least irritability) - 12 (worst irritability). |
| Secondary | Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Observer Day 28 | Day 28 | The Neuropsychiatric Inventory (NPI) is a 40-item rating scale developed to assess 12 behavioral domains. Only the NPI-Irritability (NPI-I) domain was used for this study. NPI-I measures irritability with items including: bad temper, rapid mood changes, sudden anger, impatience, crankiness, argumentative. The rater selects the frequency (1-3) and severity (1-4) of the most problematic of these behavioral aspect(s) over the preceding month. The NPI score is the product of the frequency and severity for the NPI most problematic item score. The primary outcome measure was the proportion of participants with greater than two-point increase on the Neuropsychiatric Inventory Irritability domain. The total range is 1 (least irritability) - 12 (worst irritability). |
| Secondary | Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Participant Day 28 | Day 28 | The Neuropsychiatric Inventory (NPI) is a 40-item rating scale developed to assess 12 behavioral domains. Only the NPI-Irritability (NPI-I) domain was used for this study. NPI-I measures irritability with items including: bad temper, rapid mood changes, sudden anger, impatience, crankiness, argumentative. The rater selects the frequency (1-3) and severity (1-4) of the most problematic of these behavioral aspect(s) over the preceding month. The NPI score is the product of the frequency and severity for the NPI most problematic item score. The primary outcome measure was the proportion of participants with greater than two-point increase on the Neuropsychiatric Inventory Irritability domain. The total range is 1 (least irritability) - 12 (worst irritability). |
| Secondary | Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Participants Day 28 | Day 28 | The Neuropsychiatric Inventory (NPI) is a 40-item rating scale developed to assess 12 behavioral domains. Only the NPI-Irritability (NPI-I) domain was used for this study. NPI-I measures irritability with items including: bad temper, rapid mood changes, sudden anger, impatience, crankiness, argumentative. The rater selects the frequency (1-3) and severity (1-4) of the most problematic of these behavioral aspect(s) over the preceding month. The NPI score is the product of the frequency and severity for the NPI most problematic item score. The primary outcome measure was the proportion of participants with greater than two-point increase on the Neuropsychiatric Inventory Irritability domain. The total range is 1 (least irritability) - 12 (worst irritability). |
| Secondary | Clinical Global Impressions Day 28 | 28 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 | Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory Irritability Domain Rated by Observers Day 60 | 60 days | As described above for the primary measure, assessed as a secondary measure at Day 60. The Neuropsychiatric Inventory (NPI) is a 40-item rating scale developed to assess 12 behavioral domains. Only the NPI-Irritability (NPI-I) domain was used for this study. NPI-I measures irritability with items including: bad temper, rapid mood changes, sudden anger, impatience, crankiness, argumentative. The rater selects the frequency (1-3) and severity (1-4) of the most problematic of these behavioral aspect(s) over the preceding month. The NPI score is the product of the frequency and severity for the NPI most problematic item score. The primary outcome measure was the proportion of participants with greater than two-point increase on the Neuropsychiatric Inventory Irritability domain. The total range is 1 (least irritability) - 12 (worst irritability). |
| Secondary | Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Participant Day 60 | Day 60 | The Neuropsychiatric Inventory (NPI) is a 40-item rating scale developed to assess 12 behavioral domains. Only the NPI-Irritability (NPI-I) domain was used for this study. NPI-I measures irritability with items including: bad temper, rapid mood changes, sudden anger, impatience, crankiness, argumentative. The rater selects the frequency (1-3) and severity (1-4) of the most problematic of these behavioral aspect(s) over the preceding month. The NPI score is the product of the frequency and severity for the NPI most problematic item score. The primary outcome measure was the proportion of participants with greater than two-point increase on the Neuropsychiatric Inventory Irritability domain. The total range is 1 (least irritability) - 12 (worst irritability). |
| Secondary | Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Observers Day 60 | Day 60 | The Neuropsychiatric Inventory (NPI) is a 40-item rating scale developed to assess 12 behavioral domains. Only the NPI-Irritability (NPI-I) domain was used for this study. NPI-I measures irritability with items including: bad temper, rapid mood changes, sudden anger, impatience, crankiness, argumentative. The rater selects the frequency (1-3) and severity (1-4) of the most problematic of these behavioral aspect(s) over the preceding month. The NPI score is the product of the frequency and severity for the NPI most problematic item score. The primary outcome measure was the proportion of participants with greater than two-point increase on the Neuropsychiatric Inventory Irritability domain. The total range is 1 (least irritability) - 12 (worst irritability). |
| Secondary | Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Participants Day 60 | Day 60 | The Neuropsychiatric Inventory (NPI) is a 40-item rating scale developed to assess 12 behavioral domains. Only the NPI-Irritability (NPI-I) domain was used for this study. NPI-I measures irritability with items including: bad temper, rapid mood changes, sudden anger, impatience, crankiness, argumentative. The rater selects the frequency (1-3) and severity (1-4) of the most problematic of these behavioral aspect(s) over the preceding month. The NPI score is the product of the frequency and severity for the NPI most problematic item score. The primary outcome measure was the proportion of participants with greater than two-point increase on the Neuropsychiatric Inventory Irritability domain. The total range is 1 (least irritability) - 12 (worst irritability). |
| Secondary | Clinical Global Impressions Day 60 | 60 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Observer Day 28 | Day 28 | percentage of participants NPI improve>2 | NUMBER | |
| SECONDARY | Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Observer Day 28 | Day 28 | score on a scale | MEDIAN | |
| SECONDARY | Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Participant Day 28 | Day 28 | percentage of participants NPI improve>2 | NUMBER | |
| SECONDARY | Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Participants Day 28 | Day 28 | score on a scale | MEDIAN | |
| SECONDARY | Clinical Global Impressions Day 28 | 28 Days | score on a scale | MEDIAN | |
| SECONDARY | Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory Irritability Domain Rated by Observers Day 60 | 60 days | percentage of participants NPI improve>2 | NUMBER | |
| SECONDARY | Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Participant Day 60 | Day 60 | percentage of participants NPI improve>2 | NUMBER | |
| SECONDARY | Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Observers Day 60 | Day 60 | score on a scale | MEDIAN | |
| SECONDARY | Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Participants Day 60 | Day 60 | score on a scale | MEDIAN | |
| SECONDARY | Clinical Global Impressions Day 60 | 60 days | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Observer Day 28 | Amantadine | 66.3 | percentage of participants NPI improve>2 | ||
| Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Observer Day 28 | Placebo | 66.7 | percentage of participants NPI improve>2 | ||
| Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Observer Day 28 | Amantadine | -4 | Standard Deviation 3.39 | score on a scale | |
| Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Observer Day 28 | Placebo | -4 | Standard Deviation 3.36 | score on a scale | |
| Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Participant Day 28 | Amantadine | 51.3 | percentage of participants NPI improve>2 | ||
| Proportion of Participants With >2-point Increase on Neuropsychiatric Inventory - Irritability Domain Rated by Participant Day 28 | Placebo | 40.5 | percentage of participants NPI improve>2 | ||
| Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Participants Day 28 | Amantadine | -3 | Standard Deviation 3.58 | score on a scale | |
| Change in Neuropsychiatric Inventory - Irritability Domain Assessed by Participants Day 28 | Placebo | -2 | Standard Deviation 3.9 | score on a scale | |
| Clinical Global Impressions Day 28 | Amantadine | 3.00 | Standard Deviation 1.14 | score on a scale | |
| Clinical Global Impressions Day 28 | Placebo | 3.00 | Standard Deviation 0.92 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amantadine | 82 | |
| Overall Study | STARTED | Placebo | 86 | |
| Overall Study | Completed 28-day Mid-point | Amantadine | 80 | |
| Overall Study | Completed 28-day Mid-point | Placebo | 81 | |
| Overall Study | COMPLETED | Amantadine | 75 | |
| Overall Study | COMPLETED | Placebo | 82 | |
| Overall Study | NOT COMPLETED | Amantadine | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events22
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 | headache | Nervous system disorders | Amantadine | 5 | 82 | 5 |
| other | headache | Nervous system disorders | Placebo | 2 | 86 | 2 |
| other | Insomnia/ sleep disturbance | Nervous system disorders | Amantadine | 7 | 82 | 7 |
| other | Insomnia/ sleep disturbance | Nervous system disorders | Placebo | 10 | 86 | 10 |
| other | Connstipation | Gastrointestinal disorders | Amantadine | 6 | 82 | 6 |
| other | Connstipation | Gastrointestinal disorders | Placebo | 1 | 86 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Amantadine | 5 | 82 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 86 | 1 |
| other | Other general medical | General disorders | Amantadine | 10 | 82 | 10 |
| other | Other general medical | General disorders | Placebo | 13 | 86 | 13 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amantadine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Amantadine | 36 | 82 |
| Total, other adverse events | Placebo | 33 | 86 |
| Total, serious adverse events | Amantadine | 3 | 82 |
| Total, serious adverse events | Placebo | 2 | 86 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Amantadine vs Placebo: serious adverse events |
Source 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.
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/NCT00779324
GET https://conductscience.org/api/trials/v1/NCT00779324/events?page=2