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

Phase 2

Recruiting

• Conditions: Traumatic brain injury; Post-traumatic amnesia; Neurological - Other neurological disorders; Agitation

• Registration Number: ACTRN12619000284167
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean level of agitation as assessed by the Agitated Behaviour Scale[Daily across treatment period.]