Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H8Y-MC-HBBO | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.
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The primary purpose of the study is to help answer the following research questions:
How LY 2140023 can be tolerated by patients with Schizophrenia compared to standard of care treatment in 52 weeks time period.
Whether LY 2140023 can help patients with Schizophrenia.
The study includes 2 treatment periods. Study Period I will begin at patient randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for patients randomized to treatment with LY2140023, and will begin after the patient has completed the second year of treatment. Patients who qualify for enrollment will be randomized in a 3:1 ratio (LY2140023 versus standard of care, respectively) into 2 treatment groups: flexible, twice-daily dose of LY2140023 or standard-of-care (olanzapine, risperidone, aripiprazole, or quetiapine). Those assigned to LY2140023 will have the option to continue on LY2140023 after 2 years if deemed appropriate by the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator |
| |
| LY2140023 | Experimental | 20mg, 40mg or 80mg After 104 weeks, patients have the option to continue on treatment until the end of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2140023 | Drug | Administered orally, twice daily for 104 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to discontinuation due to adverse events | Baseline through 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) | Baseline, 52 weeks | |
| Change from baseline to 52 week endpoint in Clinical Global Impression-Severity (CGI-S) | Baseline, 52 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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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. | Little Rock | Arkansas | 72201 |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 25, 2021 | |
| Reset | Sep 21, 2021 | |
| Release | Oct 21, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Olanzapine | Drug | Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks |
|
|
| Aripiprazole | Drug | Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks |
|
| Risperidone | Drug | Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks |
|
| Quetiapine | Drug | Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks |
|
| Change from baseline to 52 week endpoint in NSA-16 (16-item Negative Symptoms Assessment) | Baseline, 52 weeks |
| The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS) | 52 weeks, 104 weeks, end of study |
| Change from baseline to 52 week endpoint in PSP scale (Personal and Social Performance) | Baseline, 52 weeks |
| Change from baseline to 52 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment) | Baseline, 52 weeks |
| Change from baseline to 104 week endpoint in the Schizophrenia Resource Use Model (S-RUM) | Baseline, 104 weeks |
| Change from baseline to 104 week endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D) | Baseline, 104 weeks |
| Change from 52 week to 104 week endpoint in PANSS (Positive and Negative Syndrome Scale) | 52 weeks, 104 weeks |
| Change from 52 week to 104 week endpoint in Clinical Global Impression-Severity (CGI-S) | 52 weeks, 104 weeks |
| Change from 52 week to 104 week endpoint in NSA-16 (16-item Negative Symptoms Assessment) | 52 weeks, 104 weeks |
| Change from 104 week to study endpoint in Clinical Global Impression-Severity (CGI-S) | 104 weeks, end of study |
| Change from baseline to 104 week endpoint in PSP scale (Personal and Social Performance) | Baseline, 104 weeks |
| Change from baseline to 104 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment) | Baseline, 104 weeks |
| Change from Baseline to 52 week endpoint in the Schizophrenia Resource Use Model (S-RUM) | Baseline, 52 weeks |
| Change from 104 week to study endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D) | 104 weeks, end of study |
| Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) in a genetically defined subgroup | Baseline, 52 Weeks |
| 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. | Escondido | California | 92025 | 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. | Garden Grove | California | 92845 | United States |
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| 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. | Kiev | 2660 | Ukraine |
| 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. | Vinnytsia | 21005 | Ukraine |
| Reset | Nov 15, 2022 |
| Release | Mar 30, 2023 |
| Reset | Apr 20, 2023 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2021 | Sep 21, 2021 | |||
| Oct 21, 2022 | Nov 15, 2022 | |||
| Mar 30, 2023 | Apr 20, 2023 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C534551 | LY 2140023 |
| D000077152 | Olanzapine |
| D000068180 | Aripiprazole |
| D018967 | Risperidone |
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
Not provided
Not provided