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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
This trial is designed to assess the efficacy, safety and tolerability of flexible dose brexpiprazole as monotherapy or as combination therapy with Zoloft (Sertraline) in adult participants with PTSD.
This study will consist of a continuous 12-week, double-blind treatment period with a 14-day follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brexpiprazole + Sertraline | Experimental | Participants were administered oral brexpiprazole initial dose of 0.5 milligram (mg)/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12. |
|
| Brexpiprazole | Experimental | Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12. |
|
| Sertraline | Active Comparator | Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | Brexpiprazole oral tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score | CAPS-5:clinician-rated, structured interview to assess PTSD diagnostic status, symptoms severity as defined by DSM-5. CAPS-5 Past Week version of scale was completed at Baseline and at all visits after Baseline. CAPS-5 was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from categories: Category B:Intrusion symptoms (5 items); Category C:Avoidance symptoms (2 items); Category D:Cognition and mood symptoms (7 items); Category E:Arousal and reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B,C,D,E. Each symptom was scored 0 (Absent) to 4 (Extreme/incapacitating), to yield a score with range 0-80. Higher scores=worse outcome. Mixed model repeated measure (MMRM) was used for analysis. | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Tuscaloosa | Alabama | 35404 | United States | ||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40009045 | Derived | Hobart M, Chang D, Hefting N, Davis LL. Brexpiprazole in Combination With Sertraline and as Monotherapy in Posttraumatic Stress Disorder: A Full-Factorial Randomized Clinical Trial. J Clin Psychiatry. 2025 Feb 19;86(1):24m15577. doi: 10.4088/JCP.24m15577. |
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Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Of the 336 participants enrolled in the study, 321 participants diagnosed with post-traumatic stress disorder (PTSD) were randomized in 1:1:1:1 ratio to receive brexpiprazole monotherapy, brexpiprazole plus sertraline combination therapy, sertraline monotherapy or placebo up to Week 12.
Participants took part in the study at 48 investigative sites in the United States from 26 January 2017 to 12 November 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brexpiprazole + Sertraline | Participants were administered oral brexpiprazole initial dose of 0.5 milligram (mg)/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2017 | Oct 8, 2021 |
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| Placebo | Placebo Comparator | Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12. |
|
| Sertraline | Drug | Sertraline oral capsules. |
|
|
| Brexpiprazole Matching Placebo | Drug | Brexpiprazole matching placebo oral tablets. |
|
| Sertraline Matching Placebo | Drug | Sertraline matching placebo oral capsules. |
|
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Investigational Site | Little Rock | Arkansas | 72211 | United States |
| Investigational Site | Rogers | Arkansas | 72758 | United States |
| Investigational Site | Bellflower | California | 90706 | United States |
| Investigational Site | Beverly Hills | California | 90210 | United States |
| Investigational Site | Glendale | California | 91206 | United States |
| Investigational Site | National City | California | 91950 | United States |
| Investigational Site | Oceanside | California | 92054 | United States |
| Investigational Site | Oceanside | California | 92056 | United States |
| Investigational Site | Orange | California | 92868 | United States |
| Investigational Site | Redlands | California | 92374 | United States |
| Investigational Site | Riverside | California | 92506 | United States |
| Investigational Site | San Diego | California | 92103 | United States |
| Investigational Site | San Marcos | California | 92078 | United States |
| Investigational Site | Torrance | California | 90502 | United States |
| Investigational Site | Colorado Springs | Colorado | 80910 | United States |
| Investigational Site | Bradenton | Florida | 34201 | United States |
| Investigational Site | Fort Lauderdale | Florida | 33319 | United States |
| Investigational Site | Fort Myers | Florida | 33912 | United States |
| Investigational Site | Gainesville | Florida | 32607 | United States |
| Investigational Site | Jacksonville | Florida | 32256 | United States |
| Investigational Site | North Miami | Florida | 33161 | United States |
| Investigational Site | Orlando | Florida | 32801 | United States |
| Investigational Site | Orlando | Florida | 32806 | United States |
| Investigational Site | Tampa | Florida | 33614 | United States |
| Investigational Site | Atlanta | Georgia | 30341 | United States |
| Investigational Site | Decatur | Georgia | 30030 | United States |
| Investigational Site | Roswell | Georgia | 30076 | United States |
| Investigational Site | Chicago | Illinois | 60640 | United States |
| Investigational Site | St Louis | Missouri | 63141 | United States |
| Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Investigational Site | Berlin | New Jersey | 08009 | United States |
| Investigational Site | Princeton | New Jersey | 08540 | United States |
| Investigational Site | Brooklyn | New York | 11235 | United States |
| Investigational Site | Cedarhurst | New York | 11516 | United States |
| Investigational Site | New York | New York | 10128 | United States |
| Investigational Site | Rochester | New York | 14618 | United States |
| Investigational Site | Charlotte | North Carolina | 28211 | United States |
| Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Investigational Site | Cincinnati | Ohio | 45215 | United States |
| Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Investigational Site | Oklahoma City | Oklahoma | 73118 | United States |
| Investigational Site | Portland | Oregon | 97214 | United States |
| Investigational Site | Salem | Oregon | 97301 | United States |
| Investigational Site | Media | Pennsylvania | 19063 | United States |
| Investigational Site | Norristown | Pennsylvania | 19403 | United States |
| Investigational Site | Lincoln | Rhode Island | 02865 | United States |
| Investigational Site | Charleston | South Carolina | 29401 | United States |
| Investigational Site | Memphis | Tennessee | 38119 | United States |
| Investigational Site | Bellaire | Texas | 77401 | United States |
| Investigational Site | San Antonio | Texas | 78229 | United States |
| Investigational Site | Wichita Falls | Texas | 76309 | United States |
| Investigational Site | Everett | Washington | 98201 | United States |
| FG001 | Brexpiprazole | Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12. |
| FG002 | Sertraline | Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12. |
| FG003 | Placebo | Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12. |
| Safety Sample | Safety Sample included all participants who were randomized into this trial and were administered at least one dose of double-blind investigational medicinal product (IMP). |
|
| Intent to Treat (ITT) Sample | ITT Sample included all participants who were randomized in the trial and took at least one dose of double-blind IMP and have a Baseline and at least one post Baseline evaluation for the clinician-administered PTSD scale for diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) CAPS-5 total score. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Randomized Sample included all participants randomized into this trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brexpiprazole + Sertraline | Participants were administered oral brexpiprazole initial dose of 0.5 mg/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12. |
| BG001 | Brexpiprazole | Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12. |
| BG002 | Sertraline | Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12. |
| BG003 | Placebo | Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week12. |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 | Change From Baseline in Clinician-Administered Post-traumatic Stress Disorder (PTSD) Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (CAPS-5) Total Score | CAPS-5:clinician-rated, structured interview to assess PTSD diagnostic status, symptoms severity as defined by DSM-5. CAPS-5 Past Week version of scale was completed at Baseline and at all visits after Baseline. CAPS-5 was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from categories: Category B:Intrusion symptoms (5 items); Category C:Avoidance symptoms (2 items); Category D:Cognition and mood symptoms (7 items); Category E:Arousal and reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B,C,D,E. Each symptom was scored 0 (Absent) to 4 (Extreme/incapacitating), to yield a score with range 0-80. Higher scores=worse outcome. Mixed model repeated measure (MMRM) was used for analysis. | ITT Sample included all participants who were randomized in the trial and took at least one dose of double-blind investigational medicinal product (IMP) and have a Baseline and at least one post Baseline evaluation for the CAPS-5 total score. Overall number of participants analyzed are the number of participants with data available for analyses. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
|
|
|
|
From the first dose of the study drug up to 14 days after the last dose (Up to Week 14)
Safety Sample included all participants who were randomized into this trial and were administered at least one dose of double-blind IMP.
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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 + Sertraline | Participants were administered oral brexpiprazole initial dose of 0.5 mg/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12. | 0 | 80 | 2 | 80 | 47 | 80 |
| EG001 | Brexpiprazole | Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12. | 0 | 75 | 1 | 75 | 42 | 75 |
| EG002 | Sertraline | Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12. | 0 | 79 | 0 | 79 | 46 | 79 |
| EG003 | Placebo | Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12. | 1 | 82 | 4 | 82 | 43 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDra 21.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDra 21.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDra 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 21.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDra 21.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDra 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDra 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 21.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDra 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra 21.1 | Systematic Assessment |
| |
| Weight increase | Investigations | MedDra 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDra 21.1 | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDra 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 21.1 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDra 21.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDra 21.1 | Systematic Assessment |
| |
| Anorgasmia | Psychiatric disorders | MedDra 21.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 21.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDra 21.1 | Systematic Assessment |
| |
| Delayed ejaculation | Reproductive system and breast disorders | MedDra 21.1 | Systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDra 21.1 | Systematic Assessment |
|
Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1-609-524-6788 | clinicaltransparency@otsuka-us.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2018 | Oct 8, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| Other |
|
| Not Hispanic or Latino |
|
| Other |
|
| MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate. | MMRM | =0.3868 | LS Mean Difference | -1.74 | 2-Sided | 95 | -5.70 | 2.22 | Superiority |
| MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate. | MMRM | =0.6399 | LS Mean Difference | -0.91 | 2-Sided | 95 | -4.74 | 2.92 | Superiority |
| MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate. | MMRM | =0.0106 | LS Mean Difference | -5.08 | 2-Sided | 95 | -8.96 | -1.20 | Superiority |
| MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate. | MMRM | =0.0384 | LS Mean Difference | -4.24 | 2-Sided | 95 | -8.26 | -0.23 | Superiority |