RecruitingPhase 2ACTRN12619000284167

Use of the antipsychotic olanzapine to treat agitation in traumatic brain injury

Use of olanzapine to treat agitation in traumatic brain injury: A randomised controlled trial.

Sponsor

Monash University

Enrollment

58 participants

Start Date

Aug 12, 2019

Study Type

Interventional

Conditions

Post-traumatic amnesia Agitation

Summary

Following traumatic brain injury, patients frequently enter a state of post-traumatic amnesia and may become agitated. Agitation is threatening to staff and families, impacts access to treatment and is associated with longer hospital stays. Atypical antipsychotics are prevalent in the management of agitation despite a complete lack of well-designed studies underpinning their use in treating agitation in traumatic brain injury. We hypothesise that patients in post-traumatic amnesia, exhibiting agitation who are administered the atypical antipsychotic olanzapine will show lower levels of agitation than those administered placebo.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

After a serious head injury, many patients go through a period called post-traumatic amnesia (PTA) — a state of confusion and disorientation where they cannot form new memories. During this time, some patients become severely agitated: they may be restless, combative, or distressed in ways that make it difficult to provide care and that can be frightening for families and staff. Antipsychotic medications are commonly given to manage this agitation, but there is very little solid evidence supporting this practice. This trial is testing whether olanzapine — one of the most commonly used antipsychotic medications — is effective at reducing agitation in patients who are in post-traumatic amnesia after a traumatic brain injury. Participants will receive either olanzapine or a placebo, and their agitation levels will be measured and compared using a validated scoring tool. To be eligible, participants must have sustained a traumatic brain injury (confirmed by loss of consciousness or a low score on the Glasgow Coma Scale), currently be in a state of post-traumatic amnesia, and be showing clinically significant agitation. Participants must be between 18 and 75 years of age. People with pre-existing cognitive decline, psychotic illness, severe substance dependence, or medical reasons that make olanzapine unsafe would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Olanzapine, Optimal Environmental Management: Treatment will be administered orally in capsule form initially at a dosage of 5mg/day at night. If agitation scores do not reduce after 3 days (as measured by the Agitated Behaviour Scale), the dose will be increased by 5 mg every 3 days up to a maximum daily dose of 20mg/day. Escalation will be as follows: Escalation one - 5mg morning, 5mg night; escalation two - 5mg morning, 10mg night; escalation three - 10mg morning, 10mg night. Participants will also receive optimal environmental management to minimise agitation. Treatment will continue until the patient emerges from post-traumatic amnesia, defined as the third of three consecutive days in which a score of 12 is obtained on the Westmead Post-Traumatic Amnesia Scale, or when a maximum of 6 months in a state of post-traumatic amnesia have elapsed. Each active capsule will contain 5mg olanzapine, as well as Flocel (filler). During this trial, all participants will receive environmental management designed to minimise agitation including being located in a secure and quiet ward, avoiding restraint and overstimulation, allowing frequent rest, with dedicated, consistent staff optimising communication, reassurance and orientation. They will receive any physiotherapy, speech therapy or occupational therapy treatment on the ward. Visitors will be regulated to avoid overstimulation.