Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F1D-MC-HGMP | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.
Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day
Duration:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine | Experimental | During double-blind treatment, participants receive olanzapine at a dose of 5 milligram (mg) which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation. |
|
| Placebo | Placebo Comparator | Matching placebo administered once daily, by mouth during double-blind treatment. |
|
| Olanzapine (open-label treatment period) | Experimental | During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and Week 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | 5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) | The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Baseline, Endpoint (Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase) | Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 - 5hrs, 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. | Beijing | 100088 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24417745 | Derived | Katagiri H, Tohen M, McDonnell DP, Fujikoshi S, Case M, Kanba S, Takahashi M, Gomez JC. Safety and efficacy of olanzapine in the long-term treatment of Japanese patients with bipolar I disorder, depression: an integrated analysis. Psychiatry Clin Neurosci. 2014 Jul;68(7):498-505. doi: 10.1111/pcn.12156. Epub 2014 Mar 4. | |
| 23672672 |
Not provided
Not provided
Study Period I (2-28 days) included screening and lead-in period for discontinuation of excluded medications at least 25 hours before day of randomization. Study Period II was 6-week, double-blind (Acute Phase) of treatment. Study Period III was 18-week, open-label extension for those who completed Study Period II.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Olanzapine | During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation. |
| FG001 | Placebo | Matching placebo administered once daily, by mouth during double-blind treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind Treatment |
|
| |||||||||||||||||||||
| Open-Label Treatment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olanzapine | During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation. |
| 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 | Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) | The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Endpoint (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 | Olanzapine | During double-blind treatment, participants receive olanzapine at a dose of 5 mg. which is increased to 10 mg. per day no later than 3-7 days after Visit 2. Subsequent dose increases above 10 mg. (up to a maximum of 20 mg per day) are permitted in 5 mg. per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg. requires study discontinuation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | placebo tablets, oral, once daily at bedtime, 6 weeks |
|
| Endpoint (Week 6) |
| Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase) | Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Baseline through Endpoint (Week 6) |
| Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase) | CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The score ranges from 1 (normal, not ill) to 7 (very seriously ill). | Baseline, Endpoint (Week 6) |
| Percentage of Participants With Recovery (Acute Phase) | Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Baseline through Endpoint (Week 6 ) |
| Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase) | The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase) | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). | Baseline, Endpoint (Week 6) |
| Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase) | In the MINI Major Depressive Episode module, participants are asked a series of Yes/No questions to determine whether or not they are experiencing a major depressive episode or a major depressive episode with melancholic features. | Endpoint (Week 6) |
| Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase) | In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes. | Endpoint (Week 6) |
| Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase) | In the MINI Psychotic Features Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing mood disorder with psychotic features or current psychotic disorders. | Endpoint (Week 6) |
| Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase) | In the MINI Alcohol Abuse and Dependence Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current alcohol dependence or abuse. | Endpoint (Week 6) |
| Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase) | In the MINI Substance Dependence and Abuse Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current non-alcohol substance use dependence or abuse. | Endpoint (Week 6) |
| Percentage of Participants With Emergence of Mania During the Study (Acute Phase) | Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. | Baseline through Endpoint (Week 6) |
| Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase) | EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score. | Endpoint (Week 6) |
| Change From Baseline to Endpoint in Blood Pressure (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Weight (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Albumin (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Hematocrit (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Hemoglobin (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Prolactin (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase) | Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval). | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in Heart Rate (Acute Phase) | Baseline, Endpoint (Week 6) |
| Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase) | The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. | Baseline, Endpoint (Week 6) |
| Number of Participants With Adverse Events (Acute Phase) | Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events. | Baseline through Week 6 (Acute Phase) |
| Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase) | The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
| Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase) | Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
| Percentage of Participants With Recovery (Open-Label Phase) | Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
| Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase) | The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase) | Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the Open-Label Extension. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
| Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase) | EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score. | Endpoint (Week 24) |
| Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Weight (Open-Label Phase) | Baseline (End of Acute Phase/ Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Chloride (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Creatinine (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Platelet Count (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Prolactin (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Uric Acid (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in ECG (Open-Label Phase) | Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval). | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Change From Baseline to Endpoint in Heart Rate (Open-Label Phase) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
| Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase) | The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17). | Endpoint (Week 24) |
| Number of Participants With Adverse Events (Open-Label Phase) | Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events. | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
| China |
| 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. | Changsha | 410008 | China |
| 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. | Chengdu | 610041 | China |
| 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. | Guangzhou | 510370 | China |
| 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. | Hangzhou | 310003 | China |
| 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. | Harbin | 150001 | China |
| 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. | Kunming | 650032 | China |
| 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. | Nanjing | 210029 | China |
| 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. | Shanghai | 200030 | China |
| 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. | Wuhan | 430060 | China |
| 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. | Xi'an | 710032 | China |
| 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. | Hiroshima | 731-0501 | 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. | Shiga | 525-0037 | 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 | 170-0002 | 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. | Seongnam-si | 463-707 | 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 | 110-744 | South Korea |
| Katagiri H, Tohen M, McDonnell DP, Fujikoshi S, Case M, Kanba S, Takahashi M, Gomez JC. Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Japanese subpopulation analysis of a randomized, double-blind, placebo-controlled study. BMC Psychiatry. 2013 May 14;13:138. doi: 10.1186/1471-244X-13-138. |
| 22918966 | Derived | Tohen M, McDonnell DP, Case M, Kanba S, Ha K, Fang YR, Katagiri H, Gomez JC. Randomised, double-blind, placebo-controlled study of olanzapine in patients with bipolar I depression. Br J Psychiatry. 2012 Nov;201(5):376-82. doi: 10.1192/bjp.bp.112.108357. Epub 2012 Aug 23. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Clinical Relapse |
|
| Entry Criteria Not Met |
|
| NOT COMPLETED |
|
|
| BG001 | Placebo | Matching placebo administered once daily, by mouth during double-blind treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Age at onset, Bipolar I Disorder | Mean | Standard Deviation | years |
|
| OG001 | Placebo | Matching placebo administered once daily, by mouth during double-blind treatment. |
|
|
|
| Secondary | Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase) | Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Intention-to-treat (ITT) population; all randomized participants. | Posted | Number | percentage of participants | Endpoint (Week 6) |
|
|
|
|
| Secondary | Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase) | Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Intention-to-treat (ITT) population; all randomized participants. | Posted | Number | percentage of participants | Baseline through Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase) | CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The score ranges from 1 (normal, not ill) to 7 (very seriously ill). | Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Percentage of Participants With Recovery (Acute Phase) | Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Intention-to-treat (ITT) population; all randomized participants. | Posted | Number | percentage of participants | Baseline through Endpoint (Week 6 ) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase) | The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. | Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase) | The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). | Intention-to-treat population (ITT) with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | units on a scale | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase) | In the MINI Major Depressive Episode module, participants are asked a series of Yes/No questions to determine whether or not they are experiencing a major depressive episode or a major depressive episode with melancholic features. | Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Number | percentage of participants | Endpoint (Week 6) |
|
|
|
|
| Secondary | Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase) | In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes. | Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Number | percentage of participants | Endpoint (Week 6) |
|
|
|
|
| Secondary | Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase) | In the MINI Psychotic Features Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing mood disorder with psychotic features or current psychotic disorders. | Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Number | percentage of participants | Endpoint (Week 6) |
|
|
|
|
| Secondary | Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase) | In the MINI Alcohol Abuse and Dependence Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current alcohol dependence or abuse. | Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Number | percentage of participants | Endpoint (Week 6) |
|
|
|
|
| Secondary | Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase) | In the MINI Substance Dependence and Abuse Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current non-alcohol substance use dependence or abuse. | Intention-to-treat (ITT) population with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Number | percentage of participants | Endpoint (Week 6) |
|
|
|
| Secondary | Percentage of Participants With Emergence of Mania During the Study (Acute Phase) | Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. | Intention-to-treat (ITT) population | Posted | Number | percentage of participants | Baseline through Endpoint (Week 6) |
|
|
|
|
| Secondary | Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase) | EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score. | Participants with a normal baseline and an endpoint result. | Posted | Number | percentage of participants | Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Blood Pressure (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | mmHg (millimeters of mercury) | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Weight (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | kilograms | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | millimole/Liter | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Albumin (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | gram/Liter | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | units/Liter | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | micromole/Liter | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | trillion cells per liter ( TRIL/L) | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Hematocrit (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | proportion of blood volume | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | percent of glycosylated hemoglobin | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Hemoglobin (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | millimole/Liter of iron (Fe) | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Prolactin (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | microgram/Liter | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | ratio | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase) | Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval). | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | milliseconds | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Heart Rate (Acute Phase) | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase) | The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. | Safety population; participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Endpoint (Week 6) |
|
|
|
|
| Secondary | Number of Participants With Adverse Events (Acute Phase) | Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events. | All enrolled participants in Acute Phase | Posted | Number | participants | Baseline through Week 6 (Acute Phase) |
|
|
|
| Secondary | Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase) | The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. | Total participants in the open-label extension phase. | Posted | Number | percentage of participants | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
|
|
|
| Secondary | Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase) | Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Total participants in open-label extension phase. | Posted | Number | percentage of participants | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
|
|
|
| Secondary | Percentage of Participants With Recovery (Open-Label Phase) | Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). | Total participants in open-label extension phase. | Posted | Number | percentage of participants | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
|
|
|
| Secondary | Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase) | The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | units on a scale | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
| Secondary | Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase) | Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the Open-Label Extension. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. | Total participants in the open-label extension phase. | Posted | Number | percentage of participants | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
|
|
|
| Secondary | Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase) | EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score. | Participants who entered Open-Label Phase with a normal baseline and at least one post-baseline result. | Posted | Number | percentage of participants | Endpoint (Week 24) |
|
|
|
| Secondary | Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | millimeters of mercury | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Weight (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | kilograms | Baseline (End of Acute Phase/ Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | gram/Liter | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | units/Liter | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Chloride (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | millimole/Liter | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Creatinine (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | micromole/Liter | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | trillion cells per liter (Tril/L) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | millimole/Liter of iron (Fe) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Platelet Count (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | billion cells per liter (BILL/L) | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Prolactin (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | microgram/Liter | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Uric Acid (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | micromole/Liter | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | millimole/Liter | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in ECG (Open-Label Phase) | Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval). | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | milliseconds | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Change From Baseline to Endpoint in Heart Rate (Open-Label Phase) | Participants who entered Open-Label Phase with non-missing baseline (end of Acute Phase) and post-baseline visit, last observation carried forward (LOCF). | Posted | Mean | Standard Deviation | beats per minute | Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) |
|
|
|
|
| Secondary | Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase) | The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17). | Total participants in the open-label extension phase. | Posted | Number | percentage of participants | Endpoint (Week 24) |
|
|
|
| Secondary | Number of Participants With Adverse Events (Open-Label Phase) | Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events. | Total participants in the open-label extension phase. | Posted | Number | participants | Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) |
|
|
|
| 6 |
| 343 |
| 238 |
| 343 |
| EG001 | Placebo | Matching placebo administered once daily, by mouth during double-blind treatment. | 7 | 171 | 88 | 171 |
| EG002 | Olanzapine (Open Label Treatment Period | During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Visit 9. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Visit 10. Those on higher doses will be reduced between Visit 9 and 10 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at visit 10; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at visit 10). Dose increases beyond visit 10 are permitted and at the investigator's discretion. | 14 | 389 | 209 | 389 |
| Biliary tract disorder | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Drug exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bipolar I disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
Not provided
| D006571 | Heterocyclic Compounds |
| Baseline-Depression |
|
| Change-Depression |
|
| Baseline- Overall |
|
| Change- Overall |
|
| ANCOVA |
| 0.037 |
p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Depression score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. |
| Median Difference (Final Values) |
| -0.24 |
| 2-Sided |
| 95 |
| -0.47 |
| -0.01 |
| No |
| Superiority or Other |
| ANCOVA | 0.008 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Overall score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. | Median Difference (Final Values) | -0.30 | 2-Sided | 95 | -0.53 | -0.08 | No | Superiority or Other |
| 0.264 |
p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode with melancholic features from a Cochran-Mantel-Haenszel test using geographic region as strata. |
| 95 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel |
| 0.442 |
p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current mood disorders with psychotic features from a Cochran-Mantel-Haenszel test using geographic region as strata. |
| 95 |
| No |
| Superiority or Other |
| 0.324 |
p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol abuse from a Cochran-Mantel-Haenszel test using geographic region as strata. |
| 95 |
| No |
| Superiority or Other |
| Dystonia (N=337, 169) |
|
| Parkinsonism (N=337, 169) |
|
| Cochran-Mantel-Haenszel |
| 0.736 |
p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (parkinsonism) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata. |
| 95 |
| No |
| Superiority or Other |
| Baseline- Sitting Systolic (N=340, 169) |
|
| Change- Sitting Systolic (N=340, 169) |
|
| Baseline- Standing Diastolic (N=320, 159) |
|
| Change- Standing Diastolic (N=320, 159) |
|
| Baseline- Sitting Diastolic (N=340, 169) |
|
| Change- Sitting Diastolic (N=340, 169) |
|
| Baseline- Orthostatic Change-Systolic (N=320, 159) |
|
| Change- Orthostatic Change-Systolic (N=320, 159) |
|
| Baseline- Orthostatic Change-Diastolic (N=320, 159 |
|
| Change- Orthostatic Change-Diastolic (N=320, 159) |
|
| 0.249 |
p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | 0.146 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. | 95 | No | Superiority or Other |
| ANCOVA | 0.271 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. | 95 | No | Superiority or Other |
| ANCOVA | 0.284 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. | 95 | No | Superiority or Other |
| ANCOVA | 0.067 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. | 95 | No | Superiority or Other |
| Baseline- Cholesterol (N=329, 160) |
|
| Change- Cholesterol (N=329, 160) |
|
| Baseline-Triglycerides (N=329, 160) |
|
| Change- Triglycerides (N=329, 160) |
|
| Baseline- LDL Cholesterol (N=328, 159) |
|
| Change- LDL Cholesterol (N=328, 159) |
|
| Baseline- HDL Cholesterol (N=329, 160) |
|
| Change- HDL Cholesterol (N=329, 160) |
|
| <0.001 |
p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | 0.003 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in triglycerides from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. | 95 | No | Superiority or Other |
| ANCOVA | <0.001 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in LDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. | 95 | No | Superiority or Other |
| ANCOVA | 0.095 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in HDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. | 95 | No | Superiority or Other |
| Baseline (AST/SGOT) |
|
| Change (AST/SGOT) |
|
| Baseline (GGT) |
|
| Change (GGT) |
|
| 0.001 |
p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in AST/SGOT from Wilcoxon's rank-sum test. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | <0.001 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in GGT from Wilcoxon's rank-sum test. | 95 | No | Superiority or Other |
| Baseline- Total Bilirubin |
|
| Change- Total Bilirubin |
|
| Baseline- Uric Acid |
|
| Change- Uric Acid |
|
| <0.001 |
p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in total bilirubin from Wilcoxon's rank-sum test. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | <0.001 | p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in uric acid from Wilcoxon's rank-sum test. | 95 | No | Superiority or Other |
| Baseline- QTcB |
|
| Change- QTcB |
|
| 0.006 |
p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcB interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region. |
| 95 |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| Parkinsonism (N=385) |
|
|
| Change- Sitting Diastolic (N=383) |
|
| Baseline- Standing Systolic (N=361) |
|
| Change- Standing Systolic (N=361) |
|
| Baseline- Sitting Systolic (N=383) |
|
| Change- Sitting Systolic (N=383) |
|
| Baseline- Orthostatic Change-Diastolic (N=358) |
|
| Change- Orthostatic Change- Diastolic (N=358) |
|
| Baseline- Orthostatic Change- Systolic (N=358) |
|
| Change- Orthostatic Change- Systolic (N=358) |
|
| 0.944 |
p-value represents change from baseline to endpoint-sitting diastolic blood pressure from t-tests on change. |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.080 | p-value represents change from baseline to endpoint-standing systolic blood pressure from t-tests on change. | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.612 | p-value represents change from baseline to endpoint-sitting systolic blood pressure from t-tests on change. | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.640 | p-value represents change from baseline to endpoint-orthostatic change in diastolic blood pressure from t-tests on change. | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.122 | p-value represents change from baseline to endpoint-orthostatic change in systolic blood pressure from t-tests on change. | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Change- Total Protein |
|
| 0.002 |
p-value represents change from baseline to endpoint for total protein from Wilcoxon's signed-rank test. |
| 95 |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| Change- CPK |
|
| Baseline- GGT |
|
| Change- GGT |
|
| 0.010 |
p-value represents change from baseline to endpoint for CPK from Wilcoxon's signed-rank test. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.354 | p-value represents change from baseline to endpoint for GGT from Wilcoxon's signed-rank test. | 95 | No | Superiority or Other |
|
| Change- Cholesterol (N=380) |
|
| Baseline- Triglycerides (N=380) |
|
| Change- Triglycerides (N=380) |
|
| Baseline- LDL Cholesterol (N=378) |
|
| Change- LDL Cholesterol (N=378) |
|
| Baseline- HDL Cholesterol (N=380) |
|
| Change- HDL Cholesterol (N=380) |
|
p-value represents change from baseline to endpoint for cholesterol from t-tests on change. |
| 95 |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.055 | p-value represents change from baseline to endpoint for triglycerides from t-tests on change. | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.049 | p-value represents change from baseline to endpoint for LDL cholesterol from t-tests on change. | 95 | No | Superiority or Other |
| t-test, 2 sided | <0.001 | p-value represents change from baseline to endpoint for HDL cholesterol from t-tests on change. | 95 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Change- QTcB |
|
p-value represents change from baseline to endpoint for QTcB from t-test. |
| 95 |
| No |
| Superiority or Other |