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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001361-32 | EudraCT Number |
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The study was terminated because of recruitment challenges
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT) |
|
| Brexpiprazole 1 mg | Experimental | Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week followed by 1 mg/day. |
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| Brexpiprazole 3 mg | Experimental | Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week, 1 mg/day in the second week, followed by 3 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Once daily, tablets, orally |
| |
| Brexpiprazole 1 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Randomisation in Depressive Symptoms During the Randomised Treatment | Montgomery and Aasberg Depression Rating Scale (MADRS) total score | From randomisation to end of treatment (week 20) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 15 patients were enrolled to Period 2; only 3 patients completed due to study termination | From randomisation to follow-up (week 24) |
| Change From Randomisation in Clinical Global Impression During the Randomised Treatment |
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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 |
|---|---|---|---|---|---|---|
| US001 | National City | California | 91950 | United States | ||
| US008 |
Not provided
| Label | URL |
|---|---|
| EMA EudraCT Result Posting | View source |
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129 patients were enrolled in the study and 128 patients received open-label treatment with one of six commercially available antidepressant antidepressant treatments (ADT) together with double-blind study treatment. Only 15 patients were randomized to Period 2 before the study was terminated; 47 patients entered Period 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1 Placebo and ADT | Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT) Placebo: Once daily, tablets, orally |
| FG001 | Period 2 Placebo and ADT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Drug |
once daily dose, tablets, orally |
|
| Brexpiprazole 3 mg | Drug | once daily dose, tablets, orally |
|
Clinical Global Impression - Severity of illness (CGI-S) score
| From randomisation to end of treatment (week 20) |
| Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment | Sheehan Disability Scale (SDS) total score | From randomisation to end of treatment (week 20) |
| Change From Randomisation in Social Adaptation During the Randomised Treatment | Social Adaptation Self-evaluation Scale (SASS) total score | From randomisation to end of treatment (week 20) |
| Response During the Randomised Treatment | Based on a pre-specified decrease in MADRS total score | From randomisation to end of treatment (week 20) |
| Sustained Response During the Randomised Treatment | Based on a pre-specified decrease in MADRS total score | From randomisation to end of treatment (week 20) |
| Remission During the Randomised Treatment | Based on a pre-specified MADRS total score | From randomisation to end of treatment (week 20) |
| Sustained Remission During the Randomised Treatment | Based on a pre-specified MADRS total score | From randomisation to end of treatment (week 20) |
| 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. | From randomisation to end of treatment (week 20) |
| Orlando |
| Florida |
| 32806 |
| United States |
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally
| FG002 | Period 2 Brexpiprazole 1 mg and ADT | Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT Brexpiprazole: 1 mg once daily, tablets, orally |
| FG003 | Period 2 Brexpiprazole 3 mg and ADT | Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT Brexpiprazole: 3 mg once daily, tablets, orally |
| FG004 | Period 3 Placebo and ADT | Placebo adjunct to open-label treatment with commercially available antidepressant treatment (ADT) Placebo: Once daily, tablets, orally |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Period 2 Placebo and ADT | Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT) Placebo: Once daily, tablets, orally |
| BG001 | Period 2 Brexpiprazole 1 mg and ADT | Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT) Brexpiprazole: 1 mg once daily, tablets, orally |
| BG002 | Period 2 Brexpiprazole 3 mg and ADT | Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT) Brexpiprazole: 3 mg once daily, tablets, orally |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Adverse Events | 15 patients were enrolled to Period 2; only 3 patients completed due to study termination | Posted | Number | Adverse events | From randomisation to follow-up (week 24) |
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| Primary | Change From Randomisation in Depressive Symptoms During the Randomised Treatment | Montgomery and Aasberg Depression Rating Scale (MADRS) total score | Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected | Posted | From randomisation to end of treatment (week 20) |
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| Secondary | Change From Randomisation in Clinical Global Impression During the Randomised Treatment | Clinical Global Impression - Severity of illness (CGI-S) score | Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected | Posted | From randomisation to end of treatment (week 20) |
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| Secondary | Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment | Sheehan Disability Scale (SDS) total score | Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected | Posted | From randomisation to end of treatment (week 20) |
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| Secondary | Change From Randomisation in Social Adaptation During the Randomised Treatment | Social Adaptation Self-evaluation Scale (SASS) total score | Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected | Posted | From randomisation to end of treatment (week 20) |
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| Secondary | Response During the Randomised Treatment | Based on a pre-specified decrease in MADRS total score | Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected | Posted | From randomisation to end of treatment (week 20) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Sustained Response During the Randomised Treatment | Based on a pre-specified decrease in MADRS total score | Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected | Posted | From randomisation to end of treatment (week 20) |
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| Secondary | Remission During the Randomised Treatment | Based on a pre-specified MADRS total score | Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected | Posted | From randomisation to end of treatment (week 20) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Sustained Remission During the Randomised Treatment | Based on a pre-specified MADRS total score | Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected | Posted | From randomisation to end of treatment (week 20) |
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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. | 15 patients were enrolled to Period 2, only 3 patients completed due to study termination | Posted | Number | participants | From randomisation to end of treatment (week 20) |
|
From randomization to follow-up
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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 | Period 2 Placebo and ADT | Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT) Placebo: Once daily, tablets, orally | 0 | 6 | 2 | 6 | ||
| EG001 | Period 2 Brexpiprazole 1 mg and ADT | Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT) Brexpiprazole: 1 mg once daily, tablets, orally | 0 | 3 | 2 | 3 | ||
| EG002 | Period 2 Brexpiprazole 3 mg and ADT | Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT) Brexpiprazole: 3 mg once daily, tablets, orally | 0 | 6 | 2 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gait disturbance | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Parkinson's disease | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Bruxism | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via H. Lundbeck A/S | Study Director | LundbeckClinicalTrials@lundbeck.com |
| 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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| Adverse Event |
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| Administrative reasons |
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| Other |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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