Trial · NCT00970281
A Study of Olanzapine in Patients With Schizophrenia
NCT00970281, Phase 3, Completed, Eli Lilly and Company; results first posted 2012-02-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Olanzapine in Patients With Schizophrenia. Trials, record NCT00970281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00970281
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Olanzapine in Patients With Schizophrenia
- NCT number
- NCT00970281
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Schizophrenia
- Interventions
- Rapid-Acting Intramuscular Olanzapine, Placebo
- First posted
- 2009-09-02
- Last updated
- 2012-03-07
- Results first posted
- 2012-02-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection | Baseline, up to 2 hours after 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 | Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first 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 in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 24 Hours After the First Intramuscular (IM) Injection | Baseline, up to 24 hours after 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 | Percentage of Participants With 40% or Greater Percent Decrease in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection | Up to 2 hours after the 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 | Percentage of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) Score up to 24 Hours After the First Intramuscular (IM) Injection | up to 24 hours after the 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. |
| Secondary | Percentage of Participants With Treatment-Emergent Extrapyramidal Symptoms Based on the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS) Score up to 24 Hours After the First Intramuscular (IM) Injection | Up to 24 hours after the first IM injection | Assesses extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms; 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). Total points of 8 items are defined as DIEPSS total (0 to 32 points). Items for assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by points given to corresponding items (item 6, item 7, and item 8, respectively). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection | Baseline, up to 2 hours after first IM injection | Participants with a baseline and a value at the time, last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first injection | Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 24 Hours After the First Intramuscular (IM) Injection | Baseline, up to 24 hours after first IM injection | Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With 40% or Greater Percent Decrease in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection | Up to 2 hours after the first (IM) injection | Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) Score up to 24 Hours After the First Intramuscular (IM) Injection | up to 24 hours after the first IM injection | Participants having a post-baseline measure, last observation carried forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-Emergent Extrapyramidal Symptoms Based on the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS) Score up to 24 Hours After the First Intramuscular (IM) Injection | Up to 24 hours after the first IM injection | Participants with an abnormal value at post-baseline, last observation carried forward (LOCF). | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection | 10 mg Olanzapine | -9.2 | Standard Deviation 4.5 | units on a scale | |
| Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection | Placebo | -2.8 | Standard Deviation 5.6 | units on a scale | |
| Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | 10 mg Olanzapine | 0.25 hour after First IM Injection | -2.4 | Standard Deviation 2.9 | units on a scale |
| Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | Placebo | 0.25 hour after First IM Injection | -1.0 | Standard Deviation 3.1 | units on a scale |
| Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | 10 mg Olanzapine | 0.50 hour after First IM Injection | -5.0 | Standard Deviation 3.6 | units on a scale |
| Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | Placebo | 0.50 hour after First IM Injection | -1.9 | Standard Deviation 4.6 | units on a scale |
| Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | 10 mg Olanzapine | 1 hour after First IM Injection | -7.3 | Standard Deviation 4.9 | units on a scale |
| Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | Placebo | 1 hour after First IM Injection | -3.0 | Standard Deviation 5.2 | units on a scale |
| Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | 10 mg Olanzapine | 1.5 hour after First IM Injection | -8.2 | Standard Deviation 4.7 | units on a scale |
| Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | Placebo | 1.5 hour after First IM Injection | -2.7 | Standard Deviation 5.0 | units on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 10 mg Olanzapine | 46 | |
| Overall Study | STARTED | Placebo | 45 | |
| Overall Study | Full Analysis Set | 10 mg Olanzapine | 45 | |
| Overall Study | Full Analysis Set | Placebo | 45 | |
| Overall Study | COMPLETED | 10 mg Olanzapine | 44 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | NOT COMPLETED | 10 mg Olanzapine | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events40
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 | Bradycardia | Cardiac disorders | 10 mg Olanzapine | 0 | 45 | 0 |
| other | Bradycardia | Cardiac disorders | Placebo | 1 | 45 | 1 |
| other | Constipation | Gastrointestinal disorders | 10 mg Olanzapine | 1 | 45 | 1 |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
| other | Haemorrhoids | Gastrointestinal disorders | 10 mg Olanzapine | 1 | 45 | 1 |
| other | Haemorrhoids | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
| other | Mouth haemorrhage | Gastrointestinal disorders | 10 mg Olanzapine | 0 | 45 | 0 |
| other | Mouth haemorrhage | Gastrointestinal disorders | Placebo | 1 | 45 | 1 |
| other | Nausea | Gastrointestinal disorders | 10 mg Olanzapine | 1 | 45 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 45 | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 10 mg Olanzapine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | 10 mg Olanzapine | 13 | 45 |
| Total, other adverse events | Placebo | 6 | 45 |
| Total, serious adverse events | 10 mg Olanzapine | 0 | 45 |
| Total, serious adverse events | Placebo | 0 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23311957 | DERIVED |
Source PubMed
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 |
|---|
| 10 mg Olanzapine vs Placebo: 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/NCT00970281
GET https://conductscience.org/api/trials/v1/NCT00970281/results?page=2