Trial Outcomes & Findings for Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia (NCT NCT00797277)

Results Overview

The primary efficacy measure was PANSS-EC, which was derived from the PANSS by its originators using a principal-components factor analysis, and includes the items of tension, uncooperativeness, hostility, poor impulse control and excitement.22 The score of each item ranges from 1 (normal) to 7 (most severe), with a total sum score ranging from 5 to 35. The changes in PANSS-EC from baseline to 2 hours after the first injection were compared.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

67 participants

Primary outcome timeframe

from baseline to 120 minutes after first injection

Results posted on

2014-09-15

Participant Flow

The study was conducted at 3 psychiatric centers from September 2006 to February 2009.

A total of 294 patients were assessed initially. Before randomization, 47 patients were excluded, including "no signed informed consent" (n=20), "having received recent depot injection" (n=24), "no overt agitation after admission" (n=180)" and "newly added benzodiazepine or antipsychotics" (n=3).

Participant milestones

Participant milestones
Measure	1. IM Olanzapine Patients of this arm received 10 mg IM olanzapine after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.	2. IM Haloperidol Plus Lorazepam Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
Overall Study STARTED	37	30
Overall Study COMPLETED	37	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1. IM Olanzapine n=37 Participants Patients of this arm received 10 mg IM olanzapine after randomization	2. IM Haloperidol Pus Lorazepam n=30 Participants Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization	Total n=67 Participants Total of all reporting groups
Age, Continuous	37.1 years STANDARD_DEVIATION 10.8 • n=5 Participants	41.3 years STANDARD_DEVIATION 11.3 • n=7 Participants	39.0 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: from baseline to 120 minutes after first injection

Population: Those receiving at least one IM injection

The primary efficacy measure was PANSS-EC, which was derived from the PANSS by its originators using a principal-components factor analysis, and includes the items of tension, uncooperativeness, hostility, poor impulse control and excitement.22 The score of each item ranges from 1 (normal) to 7 (most severe), with a total sum score ranging from 5 to 35. The changes in PANSS-EC from baseline to 2 hours after the first injection were compared.

Outcome measures

Outcome measures
Measure	1. IM Olanzapine n=37 Participants 10 mg olanzapine IM injection	2. IM Haloperidol Plus Lorazepam n=30 Participants 5 mg haloperidol plus 2 mg lorazepam IM injection
The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection	-10.2 units on a scale Standard Deviation 6.5	-9.9 units on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: from baseline to 120 minutes after first injection

Population: Those receiving at least one IM injection

Agitation was further assessed by the Agitation Calmness Evaluation Scale (ACES) (Copyright 1998, Eli Lilly and Company), a single-item scale developed by Eli Lilly and Company on which 1 indicates marked agitation; 2, moderate agitation; 3, mild agitation; 4, normal; 5, mild calmness; 6, moderate calmness; 7, marked calmness; 8, deep sleep; and 9, unable to be aroused.

Outcome measures

Outcome measures
Measure	1. IM Olanzapine n=37 Participants 10 mg olanzapine IM injection	2. IM Haloperidol Plus Lorazepam n=30 Participants 5 mg haloperidol plus 2 mg lorazepam IM injection
Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection	2.14 units on a scale Standard Deviation 1.80	2.23 units on a scale Standard Deviation 1.65

Adverse Events

1. IM Olanzapine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

2. IM Haloperidol Pus Lorazepam

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	1. IM Olanzapine n=37 participants at risk Patients of this arm received 10 mg IM olanzapine after randomization	2. IM Haloperidol Pus Lorazepam n=30 participants at risk Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
Nervous system disorders dizziness	2.7% 1/37 • Number of events 1 • 24 hours collect the adverse event that occur from baseline to 24 hours after the first injection	6.7% 2/30 • Number of events 2 • 24 hours collect the adverse event that occur from baseline to 24 hours after the first injection
Nervous system disorders drowsiness	8.1% 3/37 • Number of events 3 • 24 hours collect the adverse event that occur from baseline to 24 hours after the first injection	16.7% 5/30 • Number of events 5 • 24 hours collect the adverse event that occur from baseline to 24 hours after the first injection

Additional Information

Dr. Tzung-Jeng Hwang

National Taiwan University Hospital

Phone: +886-2-23123456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place