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

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

Inclusion Criteria4

  • 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,
  • Judged to be in PTA (score < 12 on the WPTAS),
  • Judged to be in a state of clinically significant agitation (score > 21 on the ABS),
  • Aged 18-75 years, inclusive,

Exclusion Criteria2

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

Interested in this trial?

Get notified about updates and connect with the research team.

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 measur

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.


Locations(1)

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12619000284167


Related Trials