Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004982-41 | EudraCT Number |
Not provided
Not provided
Not provided
The study was terminated due to challenges with patient eligibility; the decision to terminate was not based on any safety concerns
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) |
|
| Brexpiprazole | Experimental | Brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Once daily, tablets, orally |
| |
| Brexpiprazole |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Symptoms Using CAPS-2 Total Score | Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity. | Period 2: Baseline to Week 12 (of randomized period) |
| Measure | Description | Time Frame |
|---|---|---|
| Global Clinical Impression Severity of Illness (CGI-S) Score | Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US004 | Los Angeles | California | 90024 | United States | ||
| US025 |
Not provided
417 patients were enrolled to the study and 413 patients received open-label treatment with a commercially available treatment for PTSD (PAR/SER) in Period 1. Only 40 patients were randomized to Period 2, the randomized period, before the study was terminated; 190 patients entered Period 3. Data are only reported for the randomized period.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Period 1 Placebo and PAR/SER | Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Placebo: Once daily, tablets, orally |
| FG001 | Period 2 Placebo and PAR/SER (Randomized Period) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
1 to 3 mg/day, once daily dose, tablets, orally |
|
| Period 2: Baseline to Week 12 (of randomized period) |
| Los Angeles |
| California |
| 90102 |
| United States |
| US024 | Riverside | California | 92504 | United States |
| US015 | San Diego | California | 90103 | United States |
| US008 | San Diego | California | 92123 | United States |
| US002 | Bradenton | Florida | 34201 | United States |
| US006 | Gainesville | Florida | 32607 | United States |
| US016 | Jacksonville | Florida | 32256 | United States |
| US020 | North Miami | Florida | 33161 | United States |
| US017 | Tampa | Florida | 33609 | United States |
| US012 | Indianapolis | Indiana | 46260 | United States |
| US021 | Roslindale | Massachusetts | 02131 | United States |
| US019 | Las Vegas | Nevada | 89102 | United States |
| US007 | Nashua | New Hampshire | 03060 | United States |
| US001 | The Bronx | New York | 10467 | United States |
| US009 | Cincinnati | Ohio | 45219 | United States |
| US005 | Dayton | Ohio | 45417 | United States |
| US010 | Portland | Oregon | 97210 | United States |
| US014 | Norristown | Pennsylvania | 19403 | United States |
| US011 | Memphis | Tennessee | 38119 | United States |
| US003 | Austin | Texas | 78731 | United States |
| US026 | Seattle | Washington | 98104 | United States |
| EE001 | Tallinn | Estonia |
| FI002 | Helsinki | Finland |
| FI003 | Helsinki | Finland |
| FI001 | Kuopio | Finland |
| FI006 | Oulu | Finland |
| FI005 | Tampere | Finland |
| FI004 | Turku | Finland |
| FR002 | Fort de France | France |
| FR003 | Laxou | France |
| FR004 | Nîmes | France |
| FR005 | Thuir | France |
| FR001 | Tours | France |
| IT005 | Andria | Italy |
| IT004 | Catania | Italy |
| IT003 | Lecce | Italy |
| IT001 | Pisa | Italy |
| IT002 | Siena | Italy |
| PL003 | Bialystok | Poland |
| PL004 | Gdansk | Poland |
| PL005 | Gdansk | Poland |
| PL001 | Leszno | Poland |
| PL002 | Lublin | Poland |
| RS006 | Belgrade | Serbia |
| RS004 | Niš | Serbia |
| RS005 | Novi Kneževac | Serbia |
| ZA006 | Bloemfontein | South Africa |
| ZA002 | Cape Town | South Africa |
| ZA003 | Cape Town | South Africa |
| ZA004 | Cape Town | South Africa |
| ZA005 | Cape Town | South Africa |
| ZA008 | Durban | South Africa |
| ZA007 | Port Elizabeth | South Africa |
| ZA001 | Pretoria | South Africa |
| ZA009 | Pretoria | South Africa |
| SE001 | Falun | Sweden |
| SE002 | Stockholm | Sweden |
| SE003 | Uppsala | Sweden |
Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period. Placebo: Once daily, tablets, orally |
| FG002 | Period 2 Brexpiprazole and PAR/SER (Randomized Period) | Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally |
| FG003 | Period 3 Placebo and PAR/SER | Continuation of treatment with placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) from Period 1. Placebo: Once daily, tablets, orally |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
|
| Period 3 |
|
|
The all-patients-treated set (APTS) comprises all randomized patients who took at least one dose of brexpiprazole or placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Period 2 Placebo and PAR/SER (Randomized Period) | Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period. Placebo: Once daily, tablets, orally |
| BG001 | Period 2 Brexpiprazole and PAR/SER (Randomized Period) | Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period. Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally |
| BG002 | 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 |
|
| 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 | PTSD Symptoms Using CAPS-2 Total Score | Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity. | Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done | Posted | Mean | Standard Deviation | Score | Period 2: Baseline to Week 12 (of randomized period) |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Global Clinical Impression Severity of Illness (CGI-S) Score | Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). | Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done. | Posted | Mean | Standard Deviation | Score | Period 2: Baseline to Week 12 (of randomized period) |
|
Period 2: Baseline to Week 16 (randomized period)
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 | Brexpiprazole + PAR/SER (Randomized Period) | 0 | 23 | 3 | 23 | |||
| EG001 | Placebo + PAR/SER (Randomized Period) | 0 | 17 | 8 | 17 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Galactorrhoea | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
As the study was terminated limited efficacy and safety data were collected from the randomized patients. The data are descriptive and the primary and key secondary efficacy analyses were not done.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck | A/S | LundbeckClinicalTrials@Lundbeck.com |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Administrative or other reason |
|
| Non-compliance with IMP |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Administrative or other reason |
|
| Male |
|
| OG002 | Period 2 Absolute Mean at Week 12; Placebo and PAR/SER | Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) Placebo: Once daily, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24); randomized period. |
| OG003 | Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER | Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period. Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24). |
|
|