Trial · NCT00640510
A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia
NCT00640510, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia. Trials, record NCT00640510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00640510
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia
- NCT number
- NCT00640510
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 34 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Schizophrenia
- Interventions
- Rapid Acting Intramuscular Olanzapine, Isotonic sodium chloride solution
- First posted
- 2008-03-21
- Last updated
- 2009-09-02
- Results first posted
- 2009-08-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | 2 hours post first intramuscular (IM) injection | Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35. |
| Secondary | Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | 15 min, 30 min, 60 min, 90 min post first IM injection | Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (Absent) to 7 (Extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35. |
| Secondary | Number of Responders at 2 Hours After First Intramuscular (IM) Injection | 2 hours post first IM injection | A responder was defined ast he patient with ≥ 40% decrease in the PANSS-EC total score at 2 hours after the first IM injection in comparison with baseline. (See outcome measure 1 for description of PANSS-EC). |
| Secondary | Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint | 30 min, 60 min, 90 min and 2 hours post first IM injection | The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable). Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | 2 hours post first intramuscular (IM) injection | Number of randomized patients having the measures both at baseline and post-baseline. Last Observation Carried Forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | 15 min, 30 min, 60 min, 90 min post first IM injection | Number of patients having the measure both at baseline and post-baseline. Last Observation Carried Forward. | units on a scale | MEAN |
| SECONDARY | Number of Responders at 2 Hours After First Intramuscular (IM) Injection | 2 hours post first IM injection | Number of patients having the measures both at baseline and post-baseline. Last Observation Carried Forward. | participants | NUMBER |
| SECONDARY | Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint | 30 min, 60 min, 90 min and 2 hours post first IM injection | Number of patients having the measure at post-baseline. Last Observation Carried Forward. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Olanzapine 10mg | -4.7 | Standard Deviation 4.8 | units on a scale | |
| Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Placebo | -4.6 | Standard Deviation 4.5 | units on a scale | |
| Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Olanzapine 10mg | Change from Baseline to 15 minutes | -1.2 | Standard Deviation 1.3 | units on a scale |
| Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Placebo | Change from Baseline to 15 minutes | -1.2 | Standard Deviation 1.5 | units on a scale |
| Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Olanzapine 10mg | Change from Baseline to 30 minutes | -2.9 | Standard Deviation 2.8 | units on a scale |
| Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Placebo | Change from Baseline to 30 minutes | -2.4 | Standard Deviation 2.8 | units on a scale |
| Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Olanzapine 10mg | Change from Baseline to 60 minutes | -3.8 | Standard Deviation 3.6 | units on a scale |
| Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Placebo | Change from Baseline to 60 minutes | -3.4 | Standard Deviation 4.1 | units on a scale |
| Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Olanzapine 10mg | Change from Baseline to 90 minutes | -5.1 | Standard Deviation 4.3 | units on a scale |
| Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) | IM Placebo | Change from Baseline to 90 minutes | -4.6 | Standard Deviation 4.7 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IM Olanzapine 10mg | 17 | |
| Overall Study | STARTED | IM Placebo | 17 | |
| Overall Study | COMPLETED | IM Olanzapine 10mg | 16 | |
| Overall Study | COMPLETED | IM Placebo | 15 | |
| Overall Study | NOT COMPLETED | IM Olanzapine 10mg | 1 | |
| Overall Study | NOT COMPLETED | IM Placebo | 2 |
Source ClinicalTrials.gov
Adverse events12
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 | Blood creatine phosphokinase increased | Investigations | IM Olanzapine 10mg | 0 | 17 | 0 |
| other | Blood creatine phosphokinase increased | Investigations | IM Placebo | 1 | 16 | 1 |
| other | Blood glucose increased | Investigations | IM Olanzapine 10mg | 1 | 17 | 1 |
| other | Blood glucose increased | Investigations | IM Placebo | 0 | 16 | 0 |
| other | Blood pressure increased | Investigations | IM Olanzapine 10mg | 1 | 17 | 1 |
| other | Blood pressure increased | Investigations | IM Placebo | 0 | 16 | 0 |
| other | Electrocardiogram T wave inversion | Investigations | IM Olanzapine 10mg | 0 | 17 | 0 |
| other | Electrocardiogram T wave inversion | Investigations | IM Placebo | 1 | 16 | 1 |
| other | Glucose urine present | Investigations | IM Olanzapine 10mg | 1 | 17 | 1 |
| other | Glucose urine present | Investigations | IM Placebo | 0 | 16 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IM Olanzapine 10mg | ||
| Total, all-cause mortality | IM Placebo | ||
| Total, other adverse events | IM Olanzapine 10mg | 4 | |
| Total, other adverse events | IM Placebo | 2 | |
| Total, serious adverse events | IM Olanzapine 10mg | 0 | |
| Total, serious adverse events | IM Placebo | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| IM Olanzapine 10mg vs IM Placebo: Number of Responders at 2 Hours After First Intramuscular (IM) Injection |
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/NCT00640510
GET https://conductscience.org/api/trials/v1/NCT00640510/registered