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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.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000284167
Enrollment
3
Registered
2019-02-25
Start date
2019-08-12
Completion date
2021-02-01
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 wil

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.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. A history of blunt head trauma with a loss of consciousness AND/OR an initial GCS of 3-14 AND/OR a period of PTA, 2. Judged to be in PTA (score < 12 on the WPTAS), 3. Judged to be in a state of clinically significant agitation (score > 21 on the ABS), 4. Aged 18-75 years, inclusive,

Exclusion criteria

1. History of premorbid neurocognitive decline, psychotic illness or severe substance dependence, 2. Medical or pharmacological contraindications.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026