Trial Outcomes & Findings for A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia (NCT NCT00640510)
NCT ID: NCT00640510
Last Updated: 2009-09-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
34 participants
Primary outcome timeframe
2 hours post first intramuscular (IM) injection
Results posted on
2009-09-02
Participant Flow
One patient randomized to placebo was withdrawn from study by physician and is not included in the baseline demographic data table.
Participant milestones
| Measure |
IM Olanzapine 10mg
Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
IM Placebo
Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
IM Olanzapine 10mg
Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
IM Placebo
Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
IM Olanzapine 10mg
n=17 Participants
Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
IM Placebo
n=16 Participants
Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
47.4 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Diabetes Mellitus
Yes
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Diabetes Mellitus
No
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision Diagnosis
Catatonic
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision Diagnosis
Disorganized
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision Diagnosis
Paranoid
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision Diagnosis
Undifferentiated
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision Diagnosis
Residual
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Pre-Therapy Antipsychotic Usage
Yes (>=1000 milligrams/day)
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Pre-Therapy Antipsychotic Usage
Yes (<1000 milligrams/day)
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Pre-Therapy Antipsychotic Usage
No
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age at Onset
|
22.6 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
21.3 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
22.0 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Agitation-Calmness Evaluation Scale (ACES)
|
1.8 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Body Mass Index (BMI)
|
20.7 kilograms/square centimeters
STANDARD_DEVIATION 2.9 • n=5 Participants
|
22.8 kilograms/square centimeters
STANDARD_DEVIATION 3.6 • n=7 Participants
|
21.7 kilograms/square centimeters
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Positive and Negative Syndrome Scale-Excited Component
|
23.6 units on a scale
STANDARD_DEVIATION 3.8 • n=5 Participants
|
23.5 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
23.5 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours post first intramuscular (IM) injectionPopulation: Number of randomized patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.
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.
Outcome measures
| Measure |
IM Olanzapine 10mg
n=16 Participants
Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
IM Placebo
n=16 Participants
Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
|---|---|---|
|
Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
|
-4.7 units on a scale
Standard Deviation 4.8
|
-4.6 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 15 min, 30 min, 60 min, 90 min post first IM injectionPopulation: Number of patients having the measure both at baseline and post-baseline. Last Observation Carried Forward.
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.
Outcome measures
| Measure |
IM Olanzapine 10mg
n=16 Participants
Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
IM Placebo
n=16 Participants
Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
|---|---|---|
|
Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
Change from Baseline to 15 minutes
|
-1.2 units on a scale
Standard Deviation 1.3
|
-1.2 units on a scale
Standard Deviation 1.5
|
|
Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
Change from Baseline to 30 minutes
|
-2.9 units on a scale
Standard Deviation 2.8
|
-2.4 units on a scale
Standard Deviation 2.8
|
|
Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
Change from Baseline to 60 minutes
|
-3.8 units on a scale
Standard Deviation 3.6
|
-3.4 units on a scale
Standard Deviation 4.1
|
|
Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
Change from Baseline to 90 minutes
|
-5.1 units on a scale
Standard Deviation 4.3
|
-4.6 units on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 2 hours post first IM injectionPopulation: Number of patients having the measures both at baseline and post-baseline. Last Observation Carried Forward.
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).
Outcome measures
| Measure |
IM Olanzapine 10mg
n=16 Participants
Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
IM Placebo
n=16 Participants
Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
|---|---|---|
|
Number of Responders at 2 Hours After First Intramuscular (IM) Injection
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 30 min, 60 min, 90 min and 2 hours post first IM injectionPopulation: Number of patients having the measure at post-baseline. Last Observation Carried Forward.
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.
Outcome measures
| Measure |
IM Olanzapine 10mg
n=16 Participants
Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
IM Placebo
n=16 Participants
Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
|---|---|---|
|
Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint
30 Minutes
|
1 participants
|
1 participants
|
|
Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint
60 Minutes
|
1 participants
|
1 participants
|
|
Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint
90 Minutes
|
2 participants
|
2 participants
|
|
Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint
2 Hours
|
3 participants
|
2 participants
|
Adverse Events
IM Olanzapine 10mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
IM Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IM Olanzapine 10mg
Patients will receive at least one injection of Intramuscular olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
IM Placebo
Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
|
|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/17
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Blood glucose increased
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
Investigations
Blood pressure increased
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/17
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Glucose urine present
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60