Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H8Y-JE-HBDC | 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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This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 milligrams (mg) LY2140023 | Experimental |
| |
| 80 mg LY2140023 | Experimental |
| |
| 160 mg LY2140023 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2140023 | Drug | Administered orally, twice daily for up to 7 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Utility Index (CUI) | CUI measures the efficacy (response), tolerability (time on treatment) and safety [incidence of adverse events (AEs)] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators. | Baseline through Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale | The PANSS consists of 30 items and 3 subscales designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS Total Score is the sum of the 30 items (range from 30 to 210). The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology Subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1
Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
Have any known history of receiving treatment with clozapine at any dose, as determined at baseline
Have received treatment with a depot formulation of an antipsychotic medication within the 6 months prior entering the study
Participants who are currently suicidal
Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
Participants with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, untreated thyroid condition or other serious or unstable illnesses
Have a history of one or more seizures, except for those who experienced a single simple febrile seizure between ages 6 months and 5 years
Participants are excluded if their biological father, mother, brother, sister, or child has a history of idiopathic epilepsy
Within 1 year of study enrollment, participants have a history of central nervous system infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive
Participants are excluded if they have a lifetime history of any of the following:
Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study
Leukopenia
Medical history of Human Immunodeficiency Virus positive (HIV+) status
Higher than normal blood prolactin levels
Certain electrocardiogram results
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4459 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. | Aichi | 470-1168 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25890643 | Derived | Kinon BJ, Millen BA, Zhang L, McKinzie DL. Exploratory analysis for a targeted patient population responsive to the metabotropic glutamate 2/3 receptor agonist pomaglumetad methionil in schizophrenia. Biol Psychiatry. 2015 Dec 1;78(11):754-62. doi: 10.1016/j.biopsych.2015.03.016. Epub 2015 Mar 19. |
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This study consisted of a 1-week placebo lead-in period and a 6-week randomized, double-blind treatment period. Placebo responder is defined as ≥25% improvement in Positive and Negative Syndrome Scale (PANSS) Total Score from the start of placebo lead-in period to the end of placebo lead-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 mg LY2140023 | 5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks. |
| FG001 | 80 mg LY2140023 | 40 mg of LY2140023 orally, twice daily for 6 weeks. |
| FG002 | 160 mg LY2140023 | 80 mg of LY2140023 orally, twice daily for 6 weeks. |
| FG003 | Placebo | Placebo orally, twice daily for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg LY2140023 | 5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks. |
| BG001 | 80 mg LY2140023 | 40 mg of LY2140023 orally, twice daily for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Utility Index (CUI) | CUI measures the efficacy (response), tolerability (time on treatment) and safety [incidence of adverse events (AEs)] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators. | All participants who received at least 1 dose of study drug and had CUI Total Score measurement at Week 6. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline through Week 6 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 mg LY2140023 | 5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual impairment | Eye disorders | MedDRA 15.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Placebo | Drug | Administered orally, twice daily for up to 7 weeks of treatment |
|
| Baseline, Week 6 |
| Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit. | Baseline, Week 6 |
| Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16) | The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The NSA-16 Total Score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit. | Baseline, Week 6 |
| The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide. The number of participants with statistically significant changes of the C-SSRS was the number of participants with a treatment-emergent suicidal ideation and behavior (an increase in suicidal behavior or ideation over lead-in baseline.) | Baseline up to Week 6 |
| Percentage of Participants Who Discontinued (Rate of Discontinuation) | Rate of discontinuation was calculated as the number of participants who discontinued from study due to any reason divided by the total number of participants who received study drug, then multiplied by 100. | Baseline through Week 6 |
| Japan |
| 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. | Kanagawa | 216-0003 | Japan |
| 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. | Kumamoto | 861-0002 | Japan |
| 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. | Kyoto | 625-8502 | Japan |
| 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. | Nagano | 384-8540 | Japan |
| 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. | Nagasaki | 856-0847 | Japan |
| 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. | Nara | 634-8522 | Japan |
| 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. | Osaka | 569-1041 | Japan |
| 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. | Saga | 842-0192 | Japan |
| 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. | Tokyo | 114-0024 | Japan |
| 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. | Toyama | 939-8073 | Japan |
| 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. | Yamaguchi | 759-6321 | Japan |
| 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. | Goyang-si | 410-719 | South Korea |
| 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. | Incheon | 400-711 | South Korea |
| 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. | Naju | 520-833 | South Korea |
| 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. | Seoul | 150-713 | South Korea |
| 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. | Suwon | 442-723 | South Korea |
| 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. | Yongin | 446-769 | South Korea |
| 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. | Changhua | 50550 | Taiwan |
| 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. | Hsinchu | 802 | Taiwan |
| 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. | Taipei | 110 | Taiwan |
| 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. | Taipei | 114 | Taiwan |
| Perceived Lack of Efficacy |
|
| Protocol Violation |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
| BG002 | 160 mg LY2140023 | 80 mg of LY2140023 orally, twice daily for 6 weeks. |
| BG003 | Placebo | Placebo orally, twice daily for 6 weeks. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
5 milligrams (mg) of LY2140023 orally, twice daily for 6 weeks. |
| OG001 | 80 mg LY2140023 | 40 mg of LY2140023 orally, twice daily for 6 weeks. |
| OG002 | 160 mg LY2140023 | 80 mg of LY2140023 orally, twice daily for 6 weeks. |
|
|
|
| Secondary | Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale | The PANSS consists of 30 items and 3 subscales designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS Total Score is the sum of the 30 items (range from 30 to 210). The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology Subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit. | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline PANSS measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 6 |
|
|
|
|
| Secondary | Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S) | The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit. | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline CGI-S measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 6 |
|
|
|
|
| Secondary | Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16) | The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The NSA-16 Total Score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit. | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline NSA-16 Total Score measurement. Placebo responder (defined as ≥25% improvement in the PANSS Total Score from the start of placebo lead-in period to the end of placebo lead-in period) was excluded from the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 6 |
|
|
|
|
| Secondary | The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS) | Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide. The number of participants with statistically significant changes of the C-SSRS was the number of participants with a treatment-emergent suicidal ideation and behavior (an increase in suicidal behavior or ideation over lead-in baseline.) | All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline C-SSRS measurements. | Posted | Number | participants | Baseline up to Week 6 |
|
|
|
| Secondary | Percentage of Participants Who Discontinued (Rate of Discontinuation) | Rate of discontinuation was calculated as the number of participants who discontinued from study due to any reason divided by the total number of participants who received study drug, then multiplied by 100. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline through Week 6 |
|
|
|
|
| 1 |
| 21 |
| 13 |
| 21 |
| EG001 | 80 mg LY2140023 | 40 mg of LY2140023 orally, twice daily for 6 weeks. | 2 | 21 | 13 | 21 |
| EG002 | 160 mg LY2140023 | 80 mg of LY2140023 orally, twice daily for 6 weeks. | 0 | 20 | 12 | 20 |
| EG003 | Placebo | Placebo orally, twice daily for 6 weeks. | 2 | 20 | 9 | 20 |
| Schizophrenia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
| PANSS Positive Subscore (n=19, 21, 20, 20) |
|
| PANSS Negative Subscore |
|
| PANSS General Psychopathology Subscore |
|
| 0.105 |
P-value is for PANSS Total Score. |
| LS Mean Differences |
| -11.91 |
| Standard Error of the Mean |
| 7.22 |
| 2-Sided |
| 95 |
| -26.42 |
| 2.60 |
| Superiority or Other (legacy) |
| MMRM | 0.308 | P-value is for PANSS Total Score. | LS Mean Differences | -7.96 | Standard Error of the Mean | 7.73 | 2-Sided | 95 | -23.46 | 7.55 | Superiority or Other (legacy) |
| MMRM | 0.441 | P-value is for PANSS Positive Subscore. | LS Mean Differences | -1.60 | Standard Error of the Mean | 2.06 | 2-Sided | 95 | -5.74 | 2.54 | Superiority or Other (legacy) |
| MMRM | 0.030 | P-value is for PANSS Positive Subscore. | LS Mean Differences | -4.22 | Standard Error of the Mean | 1.88 | 95 | -8.01 | -0.44 | Superiority or Other (legacy) |
| MMRM | 0.323 | P-value is for PANSS Positive Subscore. | LS Mean Differences | -1.98 | Standard Error of the Mean | 1.98 | 2-Sided | 95 | -5.96 | 2.01 | Superiority or Other (legacy) |
| MMRM | 0.285 | P-value is for PANSS Negative Subscore. | LS Mean Differences | -2.46 | Standard Error of the Mean | 2.28 | 2-Sided | 95 | -7.05 | 2.12 | Superiority or Other (legacy) |
| MMRM | 0.166 | P-value is for PANSS Negative Subscore. | LS Mean Differences | -2.92 | Standard Error of the Mean | 2.07 | 2-Sided | 95 | -7.10 | 1.26 | Superiority or Other (legacy) |
| MMRM | 0.286 | P-value is for PANSS Negative Subscore. | LS Mean Differences | -2.37 | Standard Error of the Mean | 2.20 | 2-Sided | 95 | -6.79 | 2.05 | Superiority or Other (legacy) |
| MMRM | 0.177 | P-value is for PANSS General Psychopathology Subscore. | LS Mean Differences | -5.67 | Standard Error of the Mean | 4.14 | 2-Sided | 95 | -13.96 | 2.63 | Superiority or Other (legacy) |
| MMRM | 0.178 | P-value is for PANSS General Psychopathology Subscore. | LS Mean Differences | -5.10 | Standard Error of the Mean | 3.74 | 2-Sided | 95 | -12.60 | 2.40 | Superiority or Other (legacy) |
| MMRM | 0.377 | P-value is for PANSS General Psychopathology Subscore. | LS Mean Differences | -3.61 | Standard Error of the Mean | 4.05 | 2-Sided | 95 | -11.72 | 4.51 | Superiority or Other (legacy) |
| LS Mean Differences |
| -0.24 |
| Standard Error of the Mean |
| 0.44 |
| 2-Sided |
| 95 |
| -1.12 |
| 0.65 |
| Superiority or Other (legacy) |
| MMRM | 0.395 | LS Mean Differences | 0.39 | Standard Error of the Mean | 0.46 | 2-Sided | 95 | -0.53 | 1.32 | Superiority or Other (legacy) |
| LS Mean Differences |
| 0.82 |
| Standard Error of the Mean |
| 4.26 |
| 2-Sided |
| 95 |
| -7.74 |
| 9.38 |
| Superiority or Other (legacy) |
| MMRM | 0.259 | LS Mean Differences | -5.09 | Standard Error of the Mean | 4.46 | 95 | -14.05 | 3.86 | Superiority or Other (legacy) |
| Treatment-Emergent Suicidal Behavior |
|
| 95 |
| Superiority or Other (legacy) |
| Fisher Exact | >0.999 | 95 | Superiority or Other (legacy) |