Trial · NCT01821690
Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
NCT01821690, Phase 4, Completed, Indiana University; results first posted 2026-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression. Trials, record NCT01821690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01821690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression
- NCT number
- NCT01821690
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 81 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Traumatic Brain Injury
- Interventions
- Buspirone, Placebo
- First posted
- 2013-04-01
- Last updated
- 2026-02-24
- Results first posted
- 2026-02-24
- Limitations and caveats
- No technical problems to report. Study recruitment took place over 12 years until the a priori sample size was achieved.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neuropsychiatric Inventory-Irritability Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Day 91 | Neuropsychiatric Inventory (NPI) is a 40-item instrument evaluating 12 behavioral domains with prior use in TBI. NPI-Irritability domain (NPI-I) encompasses temper outbursts, mood fluctuations, abrupt anger, impatience, irritable disposition, and argumentative behavior. Assessment involves identifying if these behaviors are present and then scoring the most concerning manifestation on severity (1=mild to 3=severe) and frequency (1-4 scale, higher=greater occurrence). Domain totals (0-12 range) represent the product of severity and frequency ratings for the predominant symptom. |
| Secondary | Neuropsychiatric Inventory-Aggression Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Day 91 | Neuropsychiatric Inventory (NPI) is a 40-item instrument evaluating 12 behavioral domains with prior use in TBI. NPI-Aggression domain (NPI-A) captures emotional reactivity, resistance to activities, obstinate conduct, lack of cooperation, verbal outbursts, profanity, and physical aggression. Assessment involves identifying if these behaviors are present and then scoring the most concerning manifestation on severity (1=mild to 3=severe) and frequency (1-4 scale, higher=greater occurrence). Domain totals (0-12 range) represent the product of severity and frequency ratings for the predominant symptom. |
| Secondary | Neuropsychiatric Inventory-Distress Irritability Domain - Observer-rated | Day 91 | Neuropsychiatric Inventory (NPI) is a 40-item instrument evaluating 12 behavioral domains with prior use in TBI. NPI-Irritability domain (NPI-I) encompasses temper outbursts, mood fluctuations, abrupt anger, impatience, irritable disposition, and argumentative behavior. Assessment involves identifying if these behaviors are present and then scoring the most concerning manifestation on severity, frequency, and distress. The NPI-I Distress quantifies the emotional burden experienced by the rater regarding the most troublesome behavior using a 6-point rating system 0 to 5 (lower scores=lower distress). |
| Secondary | Neuropsychiatric Inventory-Distress Aggression Domain - Observer Rated | Day 91 | Neuropsychiatric Inventory (NPI) is a 40-item instrument evaluating 12 behavioral domains with prior use in TBI. NPI-Aggression domain (NPI-A) captures emotional reactivity, resistance to activities, obstinate conduct, lack of cooperation, verbal outbursts, profanity, and physical aggression. Assessment involves identifying if these behaviors are present and then scoring the most concerning manifestation on severity (1=mild to 3=severe) and frequency (1-4 scale, higher=greater occurrence). Domain totals (0-12 range) represent the product of severity and frequency ratings for the predominant symptom. The NPI-A Distress quantifies the emotional burden experienced by the rater regarding the most troublesome behavior using a 6-point rating system 0 - 5 (lower scores=lower distress). |
| Secondary | St. Andrews-Swansea Neurobehavioural Outcome Scale - Observer-rated | Day 91 | A self-report measure of overall neurobehavioral function. St Andrew's-Swansea Neurobehavioural Outcome Scale (SASNOS) is a 49-item observer-rated measure of neurobehavioral dysfunction in acquired brain injury. This study utilized the 15-item aggression subscale (overt aggression, irritability, and provocative behavior). The scale uses a 7-point Likert scale ("never" to "always") for items, and raw total scores are converted into standardized T-scores (M=50),(SD=10). Higher score reflects less aggression with a clinically relevant range usually extending from below (30) (indicating significant disability/high aggression) to (70) or higher (fewer symptoms). |
| Secondary | Global Impressions of Change - Observer-rated | Day 91 | A self-report measure of overall change. Global Impression of Change (GIC) employs a 5-point Likert scale whereby observers rate perceived changes in the participant from significant improvement to substantial deterioration. High score reflects worsening. Score ranges 1 to 5: 1-much improved, 2-mildly improved, 3-unchanged, 4-mildly worsened, 5-much worsened. |
| Secondary | Personal Health Questionnaire - Participant-rated | Day 91 | A measure of depression that maps on to Diagnostic and Statistical Manual (DSM) criteria for depression. Personal Health Questionnaire-9 (PHQ-9) is a 9-item self-report depression screening based on DSM-V criteria with validity and reliability in TBI populations. Higher scores indicate greater presence of recent depression symptoms. PHQ-9 has a total score range of 0 to 27, based on 9 items scored from 0 ("not at all") to 3 ("nearly every day"). It is a validated tool for assessing depression severity in various populations, including those with traumatic brain injury. |
| Secondary | Generalized Anxiety Disorder - Participant-rated | 91 day | A self-report measure of anxiety. Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire assessing generalized anxiety disorder symptoms based on DSM-V criteria. Total score ranges from 0 to 21, where higher scores indicate greater severity of anxiety. Scores are categorized as: 0-4 (Minimal), 5-9 (Mild), 10-14 (Moderate), and 15-21 (Severe). A score of 10 or higher is commonly used as the cutoff for clinical screening. |
| Secondary | Traumatic Brain Injury-Quality of Life Anger - Participant-rated | Day 91 | A self-report measure of overall impact of anger on quality of life. TBI-Quality of Life (TBI-QOL) Anger is a 10-item measure of the continuum of anger in TBI populations that is calibrated with the Patient Reporter Outcome Measurement Information System (PROMIS) scales. The measure assesses self-reported frequency and intensity of anger symptoms-including irritability, frustration, and outward aggression-in individuals with traumatic brain injuries. A T-score metric is used, typically ranging from roughly 30 to 80+, where a mean of 50 and a standard deviation (SD) of 10 represent the general population. Higher scores indicate more severe anger. |
| Secondary | Clinical Global Impressions -- Global Improvement -- Clinician Rated. | Day 91 | Clinician rating of overall change. The Clinical Global Impressions (CGI) scale is a 3-item, 7-point observer-rated instrument used in psychiatry to assess treatment response. It measures severity of illness (1-7), global improvement (1-7), and the efficacy index (0-4) or specific combinations of therapeutic/side effects). Lower scores generally indicate better outcomes (e.g., 1="Very much improved"). CGI-Improvement (CGI-I) (1-7): Assesses change from baseline, with 1 indicating "very much improved" and 7 indicating "very much worse". |
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 | Neuropsychiatric Inventory-Irritability Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Day 91 | 3 participants withdrew | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Neuropsychiatric Inventory-Aggression Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Day 91 | 3 participants withdrew | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Neuropsychiatric Inventory-Distress Irritability Domain - Observer-rated | Day 91 | 3 participants withdrew | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Neuropsychiatric Inventory-Distress Aggression Domain - Observer Rated | Day 91 | 3 participants withdrew | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | St. Andrews-Swansea Neurobehavioural Outcome Scale - Observer-rated | Day 91 | 3 participants withdrew | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Global Impressions of Change - Observer-rated | Day 91 | 3 participants withdrew | score on a scale | MEAN |
| SECONDARY | Personal Health Questionnaire - Participant-rated | Day 91 | 3 participants withdrew | score on a scale | MEAN |
| SECONDARY | Generalized Anxiety Disorder - Participant-rated | 91 day | 3 participants withdrew | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Traumatic Brain Injury-Quality of Life Anger - Participant-rated | Day 91 | 3 participants withdrew | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impressions -- Global Improvement -- Clinician Rated. | Day 91 | 3 participants withdrew | score on a scale | MEAN |
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 |
|---|---|---|---|---|---|
| Neuropsychiatric Inventory-Irritability Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Buspirone Treatment | 30 | Participants | ||
| Neuropsychiatric Inventory-Irritability Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Buspirone Placebo | 31 | Participants | ||
| Neuropsychiatric Inventory-Aggression Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Buspirone Treatment | 28 | Participants | ||
| Neuropsychiatric Inventory-Aggression Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Buspirone Placebo | 27 | Participants | ||
| Neuropsychiatric Inventory-Distress Irritability Domain - Observer-rated | Buspirone Treatment | 2.0 | Standard Error 0.2 | Scores on a scale | |
| Neuropsychiatric Inventory-Distress Irritability Domain - Observer-rated | Buspirone Placebo | 1.7 | Standard Error 0.2 | Scores on a scale | |
| Neuropsychiatric Inventory-Distress Aggression Domain - Observer Rated | Buspirone Treatment | 1.5 | Standard Error 0.2 | Scores on a scale | |
| Neuropsychiatric Inventory-Distress Aggression Domain - Observer Rated | Buspirone Placebo | 1.3 | Standard Error 0.2 | Scores on a scale | |
| St. Andrews-Swansea Neurobehavioural Outcome Scale - Observer-rated | Buspirone Treatment | 51.7 | Standard Error 1.3 | units on a scale | |
| St. Andrews-Swansea Neurobehavioural Outcome Scale - Observer-rated | Buspirone Placebo | 53.1 | Standard Error 1.2 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buspirone Treatment | 41 | |
| Overall Study | STARTED | Buspirone Placebo | 40 | |
| Overall Study | COMPLETED | Buspirone Treatment | 38 | |
| Overall Study | COMPLETED | Buspirone Placebo | 40 | |
| Overall Study | NOT COMPLETED | Buspirone Treatment | 3 | |
| Overall Study | NOT COMPLETED | Buspirone Placebo | 0 |
Source ClinicalTrials.gov
Adverse events30
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 | Ear and labyrinth disorders | Ear and labyrinth disorders | Buspirone Treatment | 1 | 41 | |
| other | Ear and labyrinth disorders | Ear and labyrinth disorders | Buspirone Placebo | 1 | 40 | |
| other | Eye disorders | Eye disorders | Buspirone Treatment | 1 | 41 | |
| other | Eye disorders | Eye disorders | Buspirone Placebo | 0 | 40 | |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Buspirone Treatment | 5 | 41 | |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Buspirone Placebo | 6 | 40 | |
| other | General disorders and administration conditions | General disorders | Buspirone Treatment | 4 | 41 | |
| other | General disorders and administration conditions | General disorders | Buspirone Placebo | 7 | 40 | |
| other | Immune system disorders | Immune system disorders | Buspirone Treatment | 0 | 41 | |
| other | Immune system disorders | Immune system disorders | Buspirone Placebo | 1 | 40 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buspirone Treatment | 0 | 41 |
| Total, all-cause mortality | Buspirone Placebo | 0 | 40 |
| Total, other adverse events | Buspirone Treatment | 24 | 41 |
| Total, other adverse events | Buspirone Placebo | 22 | 40 |
| Total, serious adverse events | Buspirone Treatment | 0 | 41 |
| Total, serious adverse events | Buspirone Placebo | 1 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42101960 | DERIVED |
Source 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 |
|---|---|
| Buspirone Treatment vs Buspirone Placebo: Neuropsychiatric Inventory-Irritability Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Trial comparisons |
| Buspirone Treatment vs Buspirone Placebo: Neuropsychiatric Inventory-Aggression Domain - Observer-rated Proportion Improved ≥ 3 Points Baseline to Day-91 | Trial comparisons |
| Buspirone Treatment vs Buspirone Placebo: deaths from any cause | Trial comparisons |
| Buspirone Treatment vs Buspirone 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.
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/NCT01821690
GET https://conductscience.org/api/trials/v1/NCT01821690/events?page=2