Trial · NCT00797277
Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia
NCT00797277, Phase 3, Completed, National Taiwan University Hospital; results first posted 2014-09-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia. Trials, record NCT00797277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00797277
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia
- NCT number
- NCT00797277
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 67 participants, actual
- Lead sponsor
- National Taiwan University Hospital
- Conditions
- Schizophrenia, Schizoaffective Disorder, Agitation
- Interventions
- IM olanzapine, IM haloperidol plus lorazepam
- First posted
- 2008-11-25
- Last updated
- 2014-09-15
- Results first posted
- 2014-09-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection | from baseline to 120 minutes after first 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. |
| Secondary | Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection | from baseline to 120 minutes after first 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection | from baseline to 120 minutes after first injection | Those receiving at least one IM injection | units on a scale | MEAN |
| SECONDARY | Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection | from baseline to 120 minutes after first injection | Those receiving at least one IM injection | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection | 1. IM Olanzapine | -10.2 | Standard Deviation 6.5 | units on a scale | |
| The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection | 2. IM Haloperidol Plus Lorazepam | -9.9 | Standard Deviation 5.6 | units on a scale | |
| Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection | 1. IM Olanzapine | 2.14 | Standard Deviation 1.80 | units on a scale | |
| Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection | 2. IM Haloperidol Pus Lorazepam | 2.23 | Standard Deviation 1.65 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1. IM Olanzapine | 37 | |
| Overall Study | STARTED | 2. IM Haloperidol Plus Lorazepam | 30 | |
| Overall Study | COMPLETED | 1. IM Olanzapine | 37 | |
| Overall Study | COMPLETED | 2. IM Haloperidol Plus Lorazepam | 30 | |
| Overall Study | NOT COMPLETED | 1. IM Olanzapine | 0 | |
| Overall Study | NOT COMPLETED | 2. IM Haloperidol Plus Lorazepam | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | dizziness | Nervous system disorders | 1. IM Olanzapine | 1 | 37 | 1 |
| other | dizziness | Nervous system disorders | 2. IM Haloperidol Pus Lorazepam | 2 | 30 | 2 |
| other | drowsiness | Nervous system disorders | 1. IM Olanzapine | 3 | 37 | 3 |
| other | drowsiness | Nervous system disorders | 2. IM Haloperidol Pus Lorazepam | 5 | 30 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1. IM Olanzapine | ||
| Total, all-cause mortality | 2. IM Haloperidol Pus Lorazepam | ||
| Total, other adverse events | 1. IM Olanzapine | 4 | 37 |
| Total, other adverse events | 2. IM Haloperidol Pus Lorazepam | 7 | 30 |
| Total, serious adverse events | 1. IM Olanzapine | 0 | 37 |
| Total, serious adverse events | 2. IM Haloperidol Pus Lorazepam | 0 | 30 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 1. IM Olanzapine vs 2. IM Haloperidol Pus Lorazepam: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00797277
GET https://conductscience.org/api/trials/v1/NCT00797277/registered