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| ID | Type | Description | Link |
|---|---|---|---|
| F1D-US-HGLS |
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The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | |||
| Aripiprazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to test the hypothesis that olanzapine is superior to aripiprazole in the reduction of symptoms of agitation in acutely ill patients with schizophrenia, as measured by mean change in the | ||
| Positive and Negative Syndrome Scale Excited Component (PANSS-EC) over 5 days of treatment (4 continuous 24 hr treatment exposures). The null hypothesis of the study is that there is no difference between olanzapine and | ||
| aripiprazole in reducing agitation. |
| Measure | Description | Time Frame |
|---|---|---|
| The reduction in positive symptoms as measured by the Brief Psychiatric Rating Scale Positive subscale (PBRS Positive); | ||
| The reduction of symptoms of agitation as measured by Overt Agitation Severity Scale (OASS); |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | Saint Charles | Missouri | 63301 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| The proportion of patients responding to treatment and the time to response based on varying levels in the percent reduction of |
| the PANSS_EC from baseline; |
| The reduction in overall severity of psychiatric illness as measured by the Clinical Global Impression-Severity Scale (CGI-S); |
| The intensity of nursing intervention (e.g. seclusion, restraint, special nursing watch), as measured by the Global Assessment |
| of Nursing Intervention |
| The proportion of patients using pm lorazepam and the time-course of usage. |
| The proportion of patients discontinuing from the study due to lack of efficacy or due to adverse events related to worsening |
| of psychiatric illness. |
| Patient satisfaction with their medication, as measured by Drug Attitude Inventory (DA1-10). |
| A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the |
| primary objective respectively. |
| Additional secondary objectives of the study are to compare the safety of olanzapine versus aripiprazole over the course of 5 |
| days in the treatment of acutely ill patients with schizophrenia as assessed by: |
| Relative degree of sedation as measured by the Agitation Calmness Evalution Scale (ACES); |
| Review of spontaneous (unsolicited) treatment emergent adverse events; |
| Development of extrapyramidal symptoms as assessed by daily Modified Simpson-Angus and Barnes Akathisia scale scores. |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | Beachwood | Ohio | 44122 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | Canton | Ohio | 44708 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | Memphis | Tennessee | 38117 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | Rio Piedras | 00926 | Puerto Rico |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D015363 | Quinolones |
| D011804 | Quinolines |