Trial Outcomes & Findings for A Study of Olanzapine in Patients With Schizophrenia (NCT NCT00970281)
NCT ID: NCT00970281
Last Updated: 2012-03-07
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.
COMPLETED
PHASE3
91 participants
Baseline, up to 2 hours after first IM injection
2012-03-07
Participant Flow
Participant milestones
| Measure |
10 mg Olanzapine
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
45
|
|
Overall Study
Full Analysis Set
|
45
|
45
|
|
Overall Study
COMPLETED
|
44
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
16
|
Reasons for withdrawal
| Measure |
10 mg Olanzapine
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
14
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
A Study of Olanzapine in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
10 mg Olanzapine
n=45 Participants
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
n=45 Participants
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.4 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Diabetes Mellitus Status
Diabetes Mellitus - Yes
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Diabetes Mellitus Status
Diabetes Mellitus - No
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status
Catatonic
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status
Disorganized
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status
Paranoid
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status
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 Status
Residual
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Pre-therapy Antipsychotic Usage
Yes (>=1000 milligrams [mg])
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Pre-therapy Antipsychotic Usage
Yes (<1000 mg)
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Pre-therapy Antipsychotic Usage
No
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Age at Onset
|
24.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
25.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Agitation-Calmness Evaluation Scale (ACES) Score
|
1.6 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
1.6 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score
|
23.5 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
23.2 units on a scale
STANDARD_DEVIATION 4.9 • n=7 Participants
|
23.4 units on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 2 hours after first IM injectionPopulation: Participants with a baseline and a value at the time, last observation carried forward (LOCF).
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 |
10 mg Olanzapine
n=45 Participants
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
n=44 Participants
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
|---|---|---|
|
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
|
-9.2 units on a scale
Standard Deviation 4.5
|
-2.8 units on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first injectionPopulation: 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).
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 |
10 mg Olanzapine
n=45 Participants
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
n=44 Participants
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
|---|---|---|
|
Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection
0.25 hour after First IM Injection
|
-2.4 units on a scale
Standard Deviation 2.9
|
-1.0 units on a scale
Standard Deviation 3.1
|
|
Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection
0.50 hour after First IM Injection
|
-5.0 units on a scale
Standard Deviation 3.6
|
-1.9 units on a scale
Standard Deviation 4.6
|
|
Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection
1 hour after First IM Injection
|
-7.3 units on a scale
Standard Deviation 4.9
|
-3.0 units on a scale
Standard Deviation 5.2
|
|
Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection
1.5 hour after First IM Injection
|
-8.2 units on a scale
Standard Deviation 4.7
|
-2.7 units on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Baseline, up to 24 hours after first IM injectionPopulation: 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).
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 |
10 mg Olanzapine
n=45 Participants
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
n=44 Participants
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
|---|---|---|
|
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
|
-5.6 units on a scale
Standard Deviation 5.8
|
-2.8 units on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Up to 2 hours after the first (IM) injectionPopulation: 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).
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 |
10 mg Olanzapine
n=45 Participants
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
n=44 Participants
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
|---|---|---|
|
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
|
40.0 percentage of participants
|
13.6 percentage of participants
|
SECONDARY outcome
Timeframe: up to 24 hours after the first IM injectionPopulation: Participants having a post-baseline measure, last observation carried forward (LOCF).
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 |
10 mg Olanzapine
n=45 Participants
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
n=44 Participants
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
|---|---|---|
|
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
0.5 hour after First IM Injection
|
24.4 percentage of participants
|
11.4 percentage of participants
|
|
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
1 hour after First IM Injection
|
31.1 percentage of participants
|
15.9 percentage of participants
|
|
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
1.5 hours after First IM Injection
|
40.0 percentage of participants
|
13.6 percentage of participants
|
|
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
2 hours after First IM Injection
|
40.0 percentage of participants
|
13.6 percentage of participants
|
|
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
24 hours after First IM Injection
|
28.9 percentage of participants
|
15.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 hours after the first IM injectionPopulation: Participants with an abnormal value at post-baseline, last observation carried forward (LOCF).
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).
Outcome measures
| Measure |
10 mg Olanzapine
n=45 Participants
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
n=44 Participants
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
|---|---|---|
|
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
Parkinsonism (N=43, 44)
|
4.7 percentage of participants
|
6.8 percentage of participants
|
|
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
Akathisia (N=43, 45)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
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
Dystonia (N=44, 45)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
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
Dyskinesia (N=44, 45)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
10 mg Olanzapine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10 mg Olanzapine
n=45 participants at risk
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
Placebo
n=45 participants at risk
Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Fatigue
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Malaise
|
2.2%
1/45 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Pyrexia
|
2.2%
1/45 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Thirst
|
2.2%
1/45 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
2.2%
1/45 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Investigations
Blood urine present
|
0.00%
0/45
|
4.4%
2/45 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Nervous system disorders
Somnolence
|
15.6%
7/45 • Number of events 7
|
4.4%
2/45 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Ketonuria
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Vascular disorders
Orthostatic hypotension
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60