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The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-34712 + ADT | Experimental | Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADT | Drug | Once daily dosing during the duration of the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Participants With Adverse Events (AEs). | An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug. | After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score. | The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 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, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Clinical Research Medical Group | Arcadia | California | 91007 | United States | ||
| Artemis Institute for Clinical Research |
Eligible participants received daily treatment with open-label brexpiprazole (0.25 up to 3.0 milligrams (mg)/day) and commercially marketed ADT.
1036 participants entered trial, including 792 who had rolled over from previous studies and 244 de novo participants. Of the 792 rollovers, 337 were 6-week enrollers and the 52-week enrollers consisted of 699 enrolled participants (455 rollover and 244 de novo). This was a single arm study and all participants received the same treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brexpiprazole +ADT | All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| OPC-34712 | Drug | OPC-34712, Oral Tablets, 0.25 - 3 mg |
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| Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF]) |
| Mean Clinical Global Impression - Improvement (CGI-I) Scale Score. | The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline. | Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF) |
| San Diego |
| California |
| 92123 |
| United States |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| Clinical Neuroscience Solutions | Jacksonville | Florida | 32216 | United States |
| Florida Clinical Research Center | Maitland | Florida | 32751 | United States |
| Clinical Neurosciences Solutions | Orlando | Florida | 32806 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| Carman Research | Smyrna | Georgia | 30080 | United States |
| Goldpoint Clinical Research, LLC | Indianapolis | Indiana | 46240 | United States |
| Pharmasite Research | Baltimore | Maryland | 91208 | United States |
| Clinical Insights | Glen Burnie | Maryland | 21061 | United States |
| Rochester Center for Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| Center for Psychiatry and Behavioral Medicine, Inc. | Las Vegas | Nevada | 89128 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Brooklyn Medical Institute | Brooklyn | New York | 11214 | United States |
| Medical & Behavioral Health Research | New York | New York | 10023 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Oregon Center for Clinical Investigations, Inc. | Portland | Oregon | 97210 | United States |
| Oregon Center for Clinical Investigations | Salem | Oregon | 97301 | United States |
| Carolina Clinical Research Services | Columbia | South Carolina | 29201 | United States |
| FutureSearch Trials of Dallas | Dallas | Texas | 75231 | United States |
| Bayou City Research, Ltd. | Houston | Texas | 77007 | United States |
| Radiant Research | Murray | Utah | 84123 | United States |
| Psychiatric Alliance of the Blue Ridge | Charlottesville | Virginia | 22903 | United States |
| Neuroscience, Inc. | Herndon | Virginia | 20170 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Summit Research Network | Seattle | Washington | 98104 | United States |
| Northbrooke Research Center | Brown Deer | Wisconsin | 53223 | United States |
| Dean Foundation | Middleton | Wisconsin | 53562 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brexpiprazole+ADT | All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | Participants With Adverse Events (AEs). | An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug. | The primary safety dataset included all participants exposed to at least 1 dose of brexpiprazole. | Posted | Number | Participants | After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit |
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| Secondary | Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score. | The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 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, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing. | Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and at least 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase. | Posted | Mean | Standard Deviation | Units on a scale | Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF]) |
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| Secondary | Mean Clinical Global Impression - Improvement (CGI-I) Scale Score. | The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline. | Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and atleast 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase. | Posted | Mean | Standard Deviation | Units on a scale | Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF) |
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After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brexpiprazole+ADT | Participants received brexpiprazole 0.25 to 3.0mg/day plus ADT. | 29 | 697 | 684 | 1,034 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Cranial nerve paralysis | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Depression suicidal | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Depressive symptom | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Middle insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs | Otsuka Pharmaceutical Development & Commercialization, Inc | 800 562-3974 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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