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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004169-42 | EudraCT Number |
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The study was terminated because the lead-in study (14571A) in elderly was terminated; see Detailed Description.
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)
This extension safety study was terminated early because one of the lead-in studies (14571A) in elderly was terminated and because the Sponsor considered that sufficient long-term safety data has already been collected in the development programme in the population aged 18-65 yrs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brexpiprazole | Experimental | Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | 1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | Number of participants with Treatment-Emergent Adverse Events | From baseline to Week 52 |
| Number of Withdrawals | Number of withdrawals | From baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) | The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration. |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US008 | Orlando | Florida | 32806 | United States |
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| Label | URL |
|---|---|
| EudraCT (EMA) Result Posting | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brexpiprazole and ADT | Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT) Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brexpiprazole and ADT | Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT) Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Number of Participants With Treatment-Emergent Adverse Events | Number of participants with Treatment-Emergent Adverse Events | Posted | Number | participants | From baseline to Week 52 |
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From baseline to Week 52
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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 and ADT | Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT) Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
Because the study was terminated, few efficacy data were collected. These data have not been reported in accordance with the ICH E3 regarding abbreviated clinical study reports. Furthermore, no firm conclusions can be drawn regarding safety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck A/S | H. Lundbeck A/S | +45 36301311 | LundbeckClinicalTrials@lundbeck.com |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
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| From baseline to Week 52 |
| Change in Depressive Symptoms | The Montgomery and Aasberg Depression Rating Scale (MADRS) total score | From baseline to Week 52 |
| Proportion of Patients in Remission | Based on a pre-specified MADRS total score | From baseline to Week 52 |
| Change in Clinical Global Impression | Clinical Global Impression - Severity of illness (CGI-S) score | From baseline to Week 52 |
| Change in Health-related Quality of Life | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score | From baseline to Week 52 |
| Change in Health-related Quality of Life | The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient's wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline and Week 52 |
| Administrative or other reasons |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | Number of Withdrawals | Number of withdrawals | 26 patients were withdrawn; the reason for withdrawal was not poor tolerability, but mainly (23 patients) because the study was terminated. Please see withdrawn reasons in the participant flow section for the other reasons. | Posted | Number | participants | From baseline to Week 52 |
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|
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| Secondary | Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) | The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration. | all-patients treated set (APTS) | Posted | Number | participants | From baseline to Week 52 |
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|
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| Secondary | Change in Depressive Symptoms | The Montgomery and Aasberg Depression Rating Scale (MADRS) total score | None of the patients completed the study. A total of 26 patients were enrolled when the study was prematurely terminated(Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination. | Posted | From baseline to Week 52 |
|
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| Secondary | Proportion of Patients in Remission | Based on a pre-specified MADRS total score | No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination. | Posted | From baseline to Week 52 |
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| Secondary | Change in Clinical Global Impression | Clinical Global Impression - Severity of illness (CGI-S) score | No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination. | Posted | From baseline to Week 52 |
|
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| Secondary | Change in Health-related Quality of Life | Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score | No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination. | Posted | From baseline to Week 52 |
|
|
| Secondary | Change in Health-related Quality of Life | The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient's wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). | No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination. | Posted | Baseline and Week 52 |
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|
| 0 |
| 26 |
| 5 |
| 26 |
| Lethargy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Measurements |
|---|---|
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| Preparatory action towards imminent suicidal |
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| Not fatal suicide attempt |
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| Completed suicide |
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