What side effects are associated with this type of intervention?

Behavioral therapies, such as Cognitive Behavioral Therapy (CBT), are commonly used to treat symptoms of Traumatic Brain Injury (TBI), including irritability and aggression. Known side effects of these therapies are generally minimal but can include temporary increases in anxiety or emotional distress as patients confront and work through challenging thoughts and behaviors. Overall, these therapies are well-tolerated and focus on improving coping strategies and emotional regulation.

What prior FDA approvals exist?

The provided context does not mention specific FDA-approved drugs for the treatment of Traumatic Brain Injury (TBI). However, it does reference ongoing studies and trials aimed at improving behavior control in TBI patients, such as the use of buspirone for post-TBI irritability and aggression, and dietary supplementation with branched-chain amino acids (BCAAs) to improve sleep in veterans with TBI. Behavioral therapy, which modifies behavior through structured interventions and coping strategies, is a common approach in managing TBI symptoms, although specific FDA approvals for such therapies are not detailed in the context.

What other types of research exist?

Promising novel alternatives to Behavioral Therapy for TBI patients include neuromodulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct-current stimulation (tDCS). These methods have shown potential in improving neurocognition and reducing depressive symptoms. Additionally, pharmacological treatments like buspirone for managing irritability and aggression post-TBI are also being explored.

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Anxiolytic

Buspirone for Traumatic Brain Injury Irritability and Aggression

Phase 4

Recruiting

Led By Flora Hammond, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age at time of enrollment: 18 to 70 years

No surgeries planned during the 91-day participation

Must not have

Penetrating head injury as defined by head injury due to gunshot, projectile or foreign object

Clinical signs of active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 91 day

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing buspirone, a medication usually used for anxiety, to see if it can help reduce irritability and aggression in people who have had a traumatic brain injury. The study involves 74 participants who will receive buspirone. The goal is to see if buspirone can make a positive difference in their behavior by calming the brain. Buspirone is a new anxiolytic agent that has been shown to reduce aggression and anxiety without causing sedation or cognitive side effects.

Who is the study for?

This trial is for adults aged 18-70 with traumatic brain injury (TBI) who have experienced increased irritability or aggression since their injury, which occurred at least 6 months prior. Participants must not plan any medication changes during the study and need a reliable observer to report on their behavior.

What is being tested?

The trial tests whether Buspirone, a medication typically used for anxiety, can help control post-TBI irritability and aggression compared to a placebo. Patients will be randomly assigned to receive either Buspirone or an inactive pill.

What are the potential side effects?

Buspirone may cause side effects such as dizziness, nausea, headache, nervousness, lightheadedness, excitement, and trouble sleeping. The severity of these side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I have no surgeries planned for the next 3 months.

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I have been medically stable for the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a head injury caused by a gunshot, projectile, or foreign object.

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I am showing signs of an active infection.

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I struggle to communicate effectively with my caregiver.

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My neurological condition is getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 91

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 91

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 91 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neuropsychiatric Inventory-Irritability Domain

Secondary study objectives

Aggression and Irritability Impact Measure

Clinical Global Impressions

Generalized Anxiety Disorder

+7 more

Side effects data

From 2016 Phase 4 trial • 175 Patients • NCT00875836

49%

Other

41%

Dizziness or lightheaded

41%

Gastrointestinal

32%

Headache

22%

Congestion

19%

Drowsiness

18%

Insomnia

15%

Sinus/allergies/flu

13%

Musculoskeletal

Anxiety or Depression

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Buspirone

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Buspirone TreatmentExperimental Treatment1 Intervention

starting at 15 mg/day and ending at 60 mg/day as prescribed

Group II: Buspirone PlaceboPlacebo Group1 Intervention

placebo tablets as prescribed

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Buspirone

2022

Completed Phase 4

~1160

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral therapy for Traumatic Brain Injury (TBI) focuses on modifying behavior through structured interventions and coping strategies. This approach helps patients manage irritability and aggression, which are common post-TBI symptoms. By teaching patients to recognize their vulnerabilities and develop planned responses, behavioral therapy aims to improve emotional regulation and social interactions. This is crucial for TBI patients as it enhances their ability to function in daily life, reduces the risk of negative behaviors, and promotes long-term recovery.

The pros and cons of motor, memory, and emotion-related behavioral tests in the mouse traumatic brain injury model.Randomized Controlled Trials of Rehabilitation Services in the Post-acute Phase of Moderate and Severe Traumatic Brain Injury - A Systematic Review.