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
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-34712 (Brexpiprazole) and Escitalopram | Experimental | OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day |
|
| OPC-34712 and Fluoxetine | Experimental | OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day |
|
| OPC-34712 and Paroxetine CR | Experimental | OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day |
|
| OPC-34712 and Sertraline | Experimental | OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day |
|
| OPC-34712 and Duloxetine | Experimental | OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-34712 | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) - All Participants | To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole. | From screening to week 52/early termination |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score | The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. |
Not provided
Inclusion Criteria:
Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:
Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:
• Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37656180 | Derived | Newcomer JW, Meehan SR, Chen D, Brubaker M, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Prediabetes Treated With Adjunctive Brexpiprazole for Major Depressive Disorder: Pooled Analysis of Short- and Long-Term Clinical Studies. J Clin Psychiatry. 2023 Aug 28;84(5):23m14786. doi: 10.4088/JCP.23m14786. | |
| 31577867 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study population consisted of eligible participants who completed one of the double-blind, phase 3 brexpiprazole major depressive disorder (MDD) trials and who, could potentially benefit from adjunctive treatment with oral brexpiprazole for MDD.
This trial was conducted in 2944 participants at 188 sites in 11 countries: Canada, France, Germany, Hungary, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, and United States (US).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Prior Placebo | Participants who received placebo with antidepressant therapy [ADT] in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| FG001 | Prior Brexpiprazole |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2014 | May 25, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| OPC-34712 and Venlafaxine XR | Experimental | OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day |
|
| Escitalopram | Drug | Tablet |
|
|
| Fluoxetine | Drug | Capsule |
|
|
| Paroxetine CR | Drug | Controlled-release tablets |
|
|
| Sertraline | Drug | Tablets |
|
|
| Duloxetine | Drug | Delayed-release capsules |
|
|
| Venlafaxine XR | Drug | Extended-release capsules |
|
|
| From screening to week 52/early termination |
| Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score | The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. | From screening to week 52/early termination |
| Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score | The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. | From screening to week 52/early termination |
| Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score | The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst). Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place. | From screening to week 52/early termination |
| Phoenix |
| Arizona |
| United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Beverly Hills | California | United States |
| Research Site | Costa Mesa | California | United States |
| Research Site | Glendale | California | United States |
| Research Site | Irvine | California | United States |
| Research Site | Oceanside | California | United States |
| Research Site | Redlands | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | San Francisco | California | United States |
| Research Site | Santa Ana | California | United States |
| Research Site | Sherman Oaks | California | United States |
| Research Site | Temecula | California | United States |
| Research Site | Upland | California | United States |
| Research Site | Norwalk | Connecticut | United States |
| Research Site | Coral Gables | Florida | United States |
| Research Site | Coral Springs | Florida | United States |
| Research Site | Fort Myers | Florida | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Hialeah | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Jacksonville Beach | Florida | United States |
| Research Site | Melbourne | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Miami Springs | Florida | United States |
| Research Site | Oakland Park | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | The Villages | Florida | United States |
| Research Site | Winter Park | Florida | United States |
| Research Site | Alpharetta | Georgia | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Decatur | Georgia | United States |
| Research Site | Smyrna | Georgia | United States |
| Research Site | Oak Brook | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Lafayette | Indiana | United States |
| Research Site | Prairie Village | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Lake Charles | Louisiana | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Belmont | Massachusetts | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Methuen | Massachusetts | United States |
| Research Site | Watertown | Massachusetts | United States |
| Research Site | Weymouth | Massachusetts | United States |
| Research Site | Rochester Hills | Michigan | United States |
| Research Site | Creve Coeur | Missouri | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Cherry Hill | New Jersey | United States |
| Research Site | Tom River | New Jersey | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | Jamaica | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Staten Island | New York | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Wilmington | North Carolina | United States |
| Research Site | Beachwood | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Toledo | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Salem | Oregon | United States |
| Research Site | Allentown | Pennsylvania | United States |
| Research Site | Bala-Cynwyd | Pennsylvania | United States |
| Research Site | Bridgeville | Pennsylvania | United States |
| Research Site | Norristown | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Lincoln | Rhode Island | United States |
| Research Site | Columbia | South Carolina | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Arlington | Texas | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Wichita Falls | Texas | United States |
| Research Site | Murray | Utah | United States |
| Research Site | Woodstock | Vermont | United States |
| Research Site | Charlottesville | Virginia | United States |
| Research Site | Herndon | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Kirkland | Washington | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Spokane | Washington | United States |
| Research Site | Brown Deer | Wisconsin | United States |
| Research Site | Middleton | Wisconsin | United States |
| Research Site | Gatineau | Canada |
| Research Site | Penticton | Canada |
| Research Site | Pointe-Claire | Canada |
| Research Site | Sherbrooke | Canada |
| Research Site | Toronto | Canada |
| Research Site | Arcachon | France |
| Research Site | Douai | France |
| Research Site | Élancourt | France |
| Research Site | Jarnac | France |
| Research Site | Orvault | France |
| Research Site | Palaiseau | France |
| Research Site | Toulouse | France |
| Research Site | Achim | Germany |
| Research Site | Bochum | Germany |
| Research Site | Mittweida | Germany |
| Research Site | Stralsund | Germany |
| Research Site | Würzburg | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Bełchatów | Poland |
| Research Site | Bydgoszcz | Poland |
| Research Site | Katowice | Poland |
| Research Site | Kielce | Poland |
| Research Site | Lublin | Poland |
| Research Site | Poznan | Poland |
| Research Site | Pruszcz Gdański | Poland |
| Research Site | Tuszyn | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Bucharest | Romania |
| Research Site | Iași | Romania |
| Research Site | Târgu Mureş | Romania |
| Research Site | Arkhangelsk Region | Russia |
| Research Site | Moscow | Russia |
| Research Site | Roshchino | Russia |
| Research Site | Rostov-on-Don | Russia |
| Research Site | Saint Petersberg | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Smolensk | Russia |
| Research Site | Tonnel'nyy | Russia |
| Research Site | Belgrade | Serbia |
| Research Site | Kragujevac | Serbia |
| Research Site | Niš | Serbia |
| Research Site | Novi Kneževac | Serbia |
| Research Site | Bratislava | Slovakia |
| Research Site | Košice | Slovakia |
| Research Site | Michalovce | Slovakia |
| Research Site | Chernihiv | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Site | Kiev | Ukraine |
| Research Site | Poltava | Ukraine |
| Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680. |
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| FG002 | Prior ADT | Participants who received only ADT in previous double blind phase 3 studies and were not randomized, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| FG003 | Prior Seroquel | Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
comprised of all participants who signed an informed consent form (ICF) for the trial.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prior Placebo | Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| BG001 | Prior Brexpiprazole | Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| BG002 | Prior ADT | Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| BG003 | Prior Seroquel | Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Adverse Events (AEs) - All Participants | To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole. | Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs. | Posted | Count of Participants | Participants | From screening to week 52/early termination |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score | The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. | Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S. | Posted | Mean | Standard Deviation | units on a scale | From screening to week 52/early termination |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score | The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. | Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S. | Posted | Mean | Standard Deviation | units on a scale | From screening to week 52/early termination |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score | The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. | Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S. | Posted | Mean | Standard Deviation | units on a scale | From screening to week 52/early termination |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score | The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst). Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place. | Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S. | Posted | Mean | Standard Deviation | units on a scale | From screening to week 52/early termination |
|
From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related.
An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event
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 | Prior Placebo | Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. | 2 | 516 | 14 | 516 | 296 | 516 |
| EG001 | Prior Brexpiprazole | Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. | 2 | 706 | 23 | 706 | 323 | 706 |
| EG002 | Prior ADT | Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. | 0 | 1,640 | 33 | 1,640 | 787 | 1,640 |
| EG003 | Prior Seroquel | Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. | 0 | 76 | 1 | 76 | 33 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Aortic Valve Incompetence | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ventricular Dysfunction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Retinal Vein Thrombosis | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastric Ulcer Perforation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Drug Withdrawal Syndrome | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hepatitis Acute | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Electrocardiogram Qt Prolonged | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Intraductal Proliferative Breast Lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pancreatic Neuroendocrine Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rectal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Extrapyramidal Disorder | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Lumbar Radiculopathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Ruptured Cerebral Aneurysm | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Depressive Symptom | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Intentional Self-Injury | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Renal Disorder | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pelvic Adhesions | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment | General Disorders and Administration Site Conditions |
|
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Increased Appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
Until the information herein is released by Otsuka to the public domain, the contents of this document are Otsuka confidential information and should not be duplicated or re-distributed without prior written consent of Otsuka.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | 609 524 6788 | clinicaltransparency@otsuka-us.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2017 | May 25, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D005473 | Fluoxetine |
| D017374 | Paroxetine |
| D020280 | Sertraline |
| D000068736 | Duloxetine Hydrochloride |
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Participants with treatment emergent AE (TEAE) |
|
| Participants with serious TEAE |
|
| Participants with severe TEAE |
|
| Partcipants discontinued due to AEs |
|
| Prior ADT |
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| OG003 | Prior Seroquel | Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
|
|
| Prior ADT |
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| OG003 | Prior Seroquel | Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
|
|
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| OG003 | Prior Seroquel | Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
|
|
| Prior Brexpiprazole |
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| OG002 | Prior ADT | Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
| OG003 | Prior Seroquel | Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. |
|
|