Schizophrenia
Conditions
Brief summary
The primary objectives of the study is to confirm if the efficacy of intramuscular injection (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with acute psychotic agitation is greater than intramuscular placebo by comparing changes from baseline to 2 hours after the first IM injection of agitation.
Interventions
DRUGRapid-Acting Intramuscular 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
DRUGPlacebo
Administered by means of IM with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) criteria for schizophrenia. * Patients with an exacerbation of schizophrenia with acute psychotic agitation. * Patients who are hospitalized during the study. * Patients, or proxy consenters, understand the nature of the study and sign on an informed consent document. * The investigator or sub-investigator(s) judges that the patients are able to cooperate with all protocol procedures. * Patients who are considered to be with agitation and appropriate candidates for treatment with intramuscular (IM) medication by the investigator or sub-investigator(s). * The investigator or sub-investigator(s) believes that it is safe to administer IM olanzapine to the patients in consideration of safety, including the anticholinergic action of IM olanzapine. * Patients who have a score of 1 or 2 on Agitation-Calmness Evaluation Scale (ACES) before the first IM injection of investigational product.
Exclusion criteria
* Patients whose Global Assessment of Functioning (GAF) score is less than or equal to 40 within last 1 year before informed consent. * Patients with defect. * Patients whose agitation continues more than 2 weeks before informed consent. * Patients who were previously treated with antipsychotics and were considered by the investigator or sub-investigator(s) to be treatment-resistant to antipsychotics. * Patients who were treated by oral olanzapine at a dose of more than 20 milligrams (mg) for more than 4 weeks but did not improve. * Patient who have a history of participation in clozapine trials or treatment with clozapine. * Patients who have co-morbidity of mental retardation and personality disorder. * Patients whose agitation is possibly due to brain lesions such as (but not limited to) head injury, stroke, brain breeding, and cerebral infection. * Patients with sub-stupor or stupor. * One or more seizures without a clear and resolved etiology. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered. * Patients who have a history of DSM-IV-TR substance (except caffeine and nicotine) abuse within the past 30 days or substance dependence within the past 6 months before informed consent. Or patients who have a history of using illegal drug. * Patients whose agitation is caused by substance abuse or neurologic conditions, in the opinion of the investigator or sub-investigator(s). * Patients who have a diagnosis of Parkinson's disease or dementia. * Patients who are actively suicidal (at high risk for suicide attempt) in the opinion of the investigator or sub-investigator(s). * Patients with inadequately controlled diabetes, or patients whose treatment for diabetes has been changed within 4 weeks before the first IM injection of the investigational product. The investigator's discretion will supersede even if the patients do not meet the above criteria for concurrent diabetes. * Patients who have received haloperidol decanoate fluphenazine decanoate, or fluphenazine enanthate within 8 weeks before the first IM injection of investigational product. * Patients who have received risperidone long-acting injection within 12 weeks before the first IM injection of investigational product. * Patients who have a history of receiving injectable depot antipsychotics other than haloperidol decanoate, fluphenazine decanoate, fluphenazine enanthate and risperidone long-acting injection. * Patients who have received antipsychotics or other prohibited concomitant medicines within 2 hours before the first IM injection of investigational product. * Patients who have received benzodiazepines within 4 hours before the first IM injection of investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 45 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 14 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 10 mg Olanzapine | Total | Placebo |
|---|---|---|---|
| Age at Onset | 24.7 years STANDARD_DEVIATION 9.4 | 25.9 years STANDARD_DEVIATION 9.4 | 27.2 years STANDARD_DEVIATION 9.3 |
| Age Continuous | 46.4 years STANDARD_DEVIATION 11.7 | 46.7 years STANDARD_DEVIATION 11.9 | 47.0 years STANDARD_DEVIATION 12.1 |
| Agitation-Calmness Evaluation Scale (ACES) Score | 1.6 units on a scale STANDARD_DEVIATION 0.5 | 1.6 units on a scale STANDARD_DEVIATION 0.5 | 1.6 units on a scale STANDARD_DEVIATION 0.5 |
| Diabetes Mellitus Status Diabetes Mellitus - No | 42 participants | 84 participants | 42 participants |
| Diabetes Mellitus Status Diabetes Mellitus - Yes | 3 participants | 6 participants | 3 participants |
| Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status Catatonic | 0 participants | 2 participants | 2 participants |
| Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status Disorganized | 4 participants | 7 participants | 3 participants |
| Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status Paranoid | 40 participants | 80 participants | 40 participants |
| Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status Residual | 0 participants | 0 participants | 0 participants |
| Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status Undifferentiated | 1 participants | 1 participants | 0 participants |
| Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score | 23.5 units on a scale STANDARD_DEVIATION 6.1 | 23.4 units on a scale STANDARD_DEVIATION 5.5 | 23.2 units on a scale STANDARD_DEVIATION 4.9 |
| Pre-therapy Antipsychotic Usage No | 6 participants | 10 participants | 4 participants |
| Pre-therapy Antipsychotic Usage Yes (<1000 mg) | 27 participants | 57 participants | 30 participants |
| Pre-therapy Antipsychotic Usage Yes (>=1000 milligrams [mg]) | 12 participants | 23 participants | 11 participants |
| Region of Enrollment Japan | 45 participants | 90 participants | 45 participants |
| Sex: Female, Male Female | 21 Participants | 44 Participants | 23 Participants |
| Sex: Female, Male Male | 24 Participants | 46 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 45 | 6 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
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
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.
Time frame: Baseline, up to 2 hours after first IM injection
Population: Participants with a baseline and a value at the time, last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Olanzapine | 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 |
| Placebo | 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 | -2.8 units on a scale | Standard Deviation 5.6 |
Comparison: Sample size of at least 45 participants per group was necessary to verify decreases in PANSS-EC total score were significantly greater in olanzapine group than placebo group using a t-test with a power of 90% and a 2-sided significance level of 5%.p-value: <0.001ANOVA
Secondary
Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the 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.
Time frame: Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first injection
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| Placebo | 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 | -2.7 units on a scale | Standard Deviation 5 |
| Placebo | 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 | -1.0 units on a scale | Standard Deviation 3.1 |
| Placebo | Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection | 1 hour after First IM Injection | -3.0 units on a scale | Standard Deviation 5.2 |
| Placebo | 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 | -1.9 units on a scale | Standard Deviation 4.6 |
p-value: 0.009ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
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
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.
Time frame: Baseline, up to 24 hours after first IM injection
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Olanzapine | 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 |
| Placebo | 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 | -2.8 units on a scale | Standard Deviation 6.4 |
p-value: 0.008ANOVA
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
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.
Time frame: Up to 2 hours after the first (IM) injection
Population: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg Olanzapine | 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 |
| Placebo | 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 | 13.6 percentage of participants |
p-value: 0.008Fisher Exact
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
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.
Time frame: up to 24 hours after the first IM injection
Population: Participants having a post-baseline measure, last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| Placebo | 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 | 15.9 percentage of participants |
| Placebo | 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 | 11.4 percentage of participants |
| Placebo | 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 | 15.9 percentage of participants |
| Placebo | 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 | 13.6 percentage of participants |
| Placebo | 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 | 13.6 percentage of participants |
p-value: 0.167Fisher Exact
p-value: 0.134Fisher Exact
p-value: 0.008Fisher Exact
p-value: 0.008Fisher Exact
p-value: 0.204Fisher Exact
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
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).
Time frame: Up to 24 hours after the first IM injection
Population: Participants with an abnormal value at post-baseline, last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| 10 mg Olanzapine | 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 |
| Placebo | 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 |
| Placebo | 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) | 6.8 percentage of participants |
| Placebo | 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 |
| Placebo | 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 |
p-value: 1Fisher Exact