Oral Olanzapine Versus Haloperidol or Diazepam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-06-01

Brief Summary

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The purpose of this study is to determine whether oral olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or diazepam when used in the management of acute agitation in the emergency.

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Detailed Description

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1. Investigate oral use of sedating drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.
2. The multi-centre Randomised Clinical Trial will determine the safety and efficacy of oral olanzapine, in comparison with conventional medicines (haloperidol or diazepam) in a three-arm comparison for the sedation of acutely agitated patients in AEDs. Specifically, we aim to determine if administration of oral olanzapine (a)is more effective than sedation with oral haloperidol or oral diazepam alone; (b)is safer than sedation with comparison arms; (c)decreases the amount of subsequent redosing or alternative drugs required; (d)is more favourable than the haloperidol and diazepam arms with respect to safety, efficacy and adverse events.

Investigate potential variables leading to AED attendance and/or admission requiring oral sedation. These may include patient demographic and regular medications and adherence.

Conditions

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Acute Agitation Behavioural Emergency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Olanzapine

oro-dispersible tablet (wafer)(Zyprexa), 5 mg, single dose

Group Type EXPERIMENTAL

Olanzapine oro-dispersible 5Mg Tab

Intervention Type DRUG

Patient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet

Haloperidol

Haloperidol encapsulated tablet, 2 mg tablet, single dose

Group Type ACTIVE_COMPARATOR

Haloperidol 2Mg encapsulated Tab

Intervention Type DRUG

Patient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet

Diazepam

Diazepam encapsulated tablet, 2mg tablet, single dose

Group Type ACTIVE_COMPARATOR

Diazepam 2Mg encapsulated Tab

Intervention Type DRUG

Patient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet

Interventions

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Olanzapine oro-dispersible 5Mg Tab

Patient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet

Intervention Type DRUG

Haloperidol 2Mg encapsulated Tab

Patient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet

Intervention Type DRUG

Diazepam 2Mg encapsulated Tab

Patient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet

Intervention Type DRUG

Other Intervention Names

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Zyprexa

Eligibility Criteria

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Inclusion Criteria

* Accident \& Emergency Department patients
* Requiring oral drug sedation (as determined by an emergency clinician) will be enrolled.

Exclusion Criteria

* known hypersensitivity or contraindication to the study drugs
* reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)
* known pregnancy
* acute alcohol withdrawal
* refusal to take oral medication
* patients from correctional facilities

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No