A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
Study Details
Study Description
Brief Summary
To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Drug: Brexpiprazole
Brexpiprazole oral tablets.
Other Names:
Drug: Sertraline
Sertraline oral capsules.
Other Names:
Drug: Sertraline Matching Placebo
Sertraline matching placebo oral capsules.
|
Experimental: 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. |
Drug: Brexpiprazole
Brexpiprazole oral tablets.
Other Names:
Drug: Sertraline Matching Placebo
Sertraline matching placebo oral capsules.
|
Active Comparator: 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. |
Drug: Sertraline
Sertraline oral capsules.
Other Names:
Drug: Brexpiprazole Matching Placebo
Brexpiprazole matching placebo oral tablets.
Drug: Sertraline Matching Placebo
Sertraline matching placebo oral capsules.
|
Placebo Comparator: Placebo Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12. |
Drug: Brexpiprazole Matching Placebo
Brexpiprazole matching placebo oral tablets.
Drug: Sertraline Matching Placebo
Sertraline matching placebo oral capsules.
|
Outcome Measures
Primary Outcome Measures
- 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 [Baseline, Week 12]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Male and female participants between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)
Exclusion Criteria:
-
Index trauma event >15 years before screening
-
Index trauma event at age <16
-
Any traumatic event within 3 months of screening
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Investigational Site | Tuscaloosa | Alabama | United States | 35404 |
2 | Investigational Site | Phoenix | Arizona | United States | 85032 |
3 | Investigational Site | Little Rock | Arkansas | United States | 72211 |
4 | Investigational Site | Rogers | Arkansas | United States | 72758 |
5 | Investigational Site | Bellflower | California | United States | 90706 |
6 | Investigational Site | Beverly Hills | California | United States | 90210 |
7 | Investigational Site | Glendale | California | United States | 91206 |
8 | Investigational Site | National City | California | United States | 91950 |
9 | Investigational Site | Oceanside | California | United States | 92054 |
10 | Investigational Site | Oceanside | California | United States | 92056 |
11 | Investigational Site | Orange | California | United States | 92868 |
12 | Investigational Site | Redlands | California | United States | 92374 |
13 | Investigational Site | Riverside | California | United States | 92506 |
14 | Investigational Site | San Diego | California | United States | 92103 |
15 | Investigational Site | San Marcos | California | United States | 92078 |
16 | Investigational Site | Torrance | California | United States | 90502 |
17 | Investigational Site | Colorado Springs | Colorado | United States | 80910 |
18 | Investigational Site | Bradenton | Florida | United States | 34201 |
19 | Investigational Site | Fort Lauderdale | Florida | United States | 33319 |
20 | Investigational Site | Fort Myers | Florida | United States | 33912 |
21 | Investigational Site | Gainesville | Florida | United States | 32607 |
22 | Investigational Site | Jacksonville | Florida | United States | 32256 |
23 | Investigational Site | North Miami | Florida | United States | 33161 |
24 | Investigational Site | Orlando | Florida | United States | 32801 |
25 | Investigational Site | Orlando | Florida | United States | 32806 |
26 | Investigational Site | Tampa | Florida | United States | 33614 |
27 | Investigational Site | Atlanta | Georgia | United States | 30341 |
28 | Investigational Site | Decatur | Georgia | United States | 30030 |
29 | Investigational Site | Roswell | Georgia | United States | 30076 |
30 | Investigational Site | Chicago | Illinois | United States | 60640 |
31 | Investigational Site | Saint Louis | Missouri | United States | 63141 |
32 | Investigational Site | Las Vegas | Nevada | United States | 89102 |
33 | Investigational Site | Berlin | New Jersey | United States | 08009 |
34 | Investigational Site | Princeton | New Jersey | United States | 08540 |
35 | Investigational Site | Brooklyn | New York | United States | 11235 |
36 | Investigational Site | Cedarhurst | New York | United States | 11516 |
37 | Investigational Site | New York | New York | United States | 10128 |
38 | Investigational Site | Rochester | New York | United States | 14618 |
39 | Investigational Site | Charlotte | North Carolina | United States | 28211 |
40 | Investigational Site | Raleigh | North Carolina | United States | 27609 |
41 | Investigational Site | Cincinnati | Ohio | United States | 45215 |
42 | Investigational Site | Oklahoma City | Oklahoma | United States | 73103 |
43 | Investigational Site | Oklahoma City | Oklahoma | United States | 73118 |
44 | Investigational Site | Portland | Oregon | United States | 97214 |
45 | Investigational Site | Salem | Oregon | United States | 97301 |
46 | Investigational Site | Media | Pennsylvania | United States | 19063 |
47 | Investigational Site | Norristown | Pennsylvania | United States | 19403 |
48 | Investigational Site | Lincoln | Rhode Island | United States | 02865 |
49 | Investigational Site | Charleston | South Carolina | United States | 29401 |
50 | Investigational Site | Memphis | Tennessee | United States | 38119 |
51 | Investigational Site | Bellaire | Texas | United States | 77401 |
52 | Investigational Site | San Antonio | Texas | United States | 78229 |
53 | Investigational Site | Wichita Falls | Texas | United States | 76309 |
54 | Investigational Site | Everett | Washington | United States | 98201 |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- H. Lundbeck A/S
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 331-201-00061
Study Results
Participant Flow
Recruitment Details | Participants took part in the study at 48 investigative sites in the United States from 26 January 2017 to 12 November 2018. |
---|---|
Pre-assignment Detail | 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. |
Arm/Group Title | Brexpiprazole + Sertraline | Brexpiprazole | Sertraline | Placebo |
---|---|---|---|---|
Arm/Group Description | 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. | 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. | 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. | Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12. |
Period Title: Overall Study | ||||
STARTED | 82 | 75 | 81 | 83 |
Safety Sample | 80 | 75 | 79 | 82 |
Intent to Treat (ITT) Sample | 79 | 72 | 77 | 80 |
COMPLETED | 58 | 50 | 59 | 64 |
NOT COMPLETED | 24 | 25 | 22 | 19 |
Baseline Characteristics
Arm/Group Title | Brexpiprazole + Sertraline | Brexpiprazole | Sertraline | Placebo | Total |
---|---|---|---|---|---|
Arm/Group Description | 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. | 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. | 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. | Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week12. | Total of all reporting groups |
Overall Participants | 82 | 75 | 81 | 83 | 321 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
38.4
(11.9)
|
39.3
(10.6)
|
38.6
(10.9)
|
40.3
(11.0)
|
39.2
(11.1)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
51
62.2%
|
49
65.3%
|
51
63%
|
48
57.8%
|
199
62%
|
Male |
31
37.8%
|
26
34.7%
|
30
37%
|
35
42.2%
|
122
38%
|
Race/Ethnicity, Customized (Count of Participants) | |||||
American Indian or Alaska Native |
1
1.2%
|
1
1.3%
|
0
0%
|
2
2.4%
|
4
1.2%
|
Asian |
1
1.2%
|
2
2.7%
|
0
0%
|
1
1.2%
|
4
1.2%
|
Native Hawaiian or Other Pacific Islander |
1
1.2%
|
1
1.3%
|
0
0%
|
0
0%
|
2
0.6%
|
Black or African American |
21
25.6%
|
23
30.7%
|
22
27.2%
|
26
31.3%
|
92
28.7%
|
White |
55
67.1%
|
43
57.3%
|
53
65.4%
|
46
55.4%
|
197
61.4%
|
Other |
3
3.7%
|
5
6.7%
|
6
7.4%
|
8
9.6%
|
22
6.9%
|
Race/Ethnicity, Customized (Count of Participants) | |||||
Hispanic or Latino |
13
15.9%
|
11
14.7%
|
11
13.6%
|
14
16.9%
|
49
15.3%
|
Not Hispanic or Latino |
68
82.9%
|
64
85.3%
|
70
86.4%
|
69
83.1%
|
271
84.4%
|
Other |
1
1.2%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
Region of Enrollment (Count of Participants) | |||||
United States |
82
100%
|
75
100%
|
81
100%
|
83
100%
|
321
100%
|
Outcome Measures
Title | 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 |
---|---|
Description | 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. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Brexpiprazole + Sertraline | Brexpiprazole | Sertraline | Placebo |
---|---|---|---|---|
Arm/Group Description | 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. | 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. | 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. | Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12. |
Measure Participants | 59 | 48 | 58 | 62 |
Least Squares Mean (Standard Error) [score on a scale] |
-16.4
(1.43)
|
-12.2
(1.57)
|
-11.4
(1.46)
|
-10.5
(1.40)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brexpiprazole + Sertraline, Placebo |
---|---|---|
Comments | MMRM analysis with an unstructured (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. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | =0.0021 |
Comments | ||
Method | Mixed Model Repeated Measures (MMRM) | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares (LS ) Mean Difference |
Estimated Value | -5.99 | |
Confidence Interval |
(2-Sided) 95% -9.79 to -2.19 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brexpiprazole, Placebo |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | =0.3868 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -1.74 | |
Confidence Interval |
(2-Sided) 95% -5.70 to 2.22 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Sertraline, Placebo |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | =0.6399 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -0.91 | |
Confidence Interval |
(2-Sided) 95% -4.74 to 2.92 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brexpiprazole + Sertraline, Sertraline |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | =0.0106 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -5.08 | |
Confidence Interval |
(2-Sided) 95% -8.96 to -1.20 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brexpiprazole + Sertraline, Brexpiprazole |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | =0.0384 |
Comments | ||
Method | MMRM | |
Comments | ||
Method of Estimation | Estimation Parameter | LS Mean Difference |
Estimated Value | -4.24 | |
Confidence Interval |
(2-Sided) 95% -8.26 to -0.23 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | From the first dose of the study drug up to 14 days after the last dose (Up to Week 14) | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Safety Sample included all participants who were randomized into this trial and were administered at least one dose of double-blind IMP. | |||||||
Arm/Group Title | Brexpiprazole + Sertraline | Brexpiprazole | Sertraline | Placebo | ||||
Arm/Group Description | 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. | 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. | 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. | Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12. | ||||
All Cause Mortality |
||||||||
Brexpiprazole + Sertraline | Brexpiprazole | Sertraline | Placebo | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/80 (0%) | 0/75 (0%) | 0/79 (0%) | 1/82 (1.2%) | ||||
Serious Adverse Events |
||||||||
Brexpiprazole + Sertraline | Brexpiprazole | Sertraline | Placebo | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/80 (2.5%) | 1/75 (1.3%) | 0/79 (0%) | 4/82 (4.9%) | ||||
General disorders | ||||||||
Chest pain | 0/80 (0%) | 0/75 (0%) | 0/79 (0%) | 1/82 (1.2%) | ||||
Hepatobiliary disorders | ||||||||
Bile duct stone | 0/80 (0%) | 0/75 (0%) | 0/79 (0%) | 1/82 (1.2%) | ||||
Injury, poisoning and procedural complications | ||||||||
Animal bite | 0/80 (0%) | 1/75 (1.3%) | 0/79 (0%) | 0/82 (0%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Back pain | 1/80 (1.3%) | 0/75 (0%) | 0/79 (0%) | 1/82 (1.2%) | ||||
Osteonecrosis | 0/80 (0%) | 0/75 (0%) | 0/79 (0%) | 1/82 (1.2%) | ||||
Psychiatric disorders | ||||||||
Suicide attempt | 1/80 (1.3%) | 0/75 (0%) | 0/79 (0%) | 0/82 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Brexpiprazole + Sertraline | Brexpiprazole | Sertraline | Placebo | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 47/80 (58.8%) | 42/75 (56%) | 46/79 (58.2%) | 43/82 (52.4%) | ||||
Gastrointestinal disorders | ||||||||
Constipation | 4/80 (5%) | 2/75 (2.7%) | 4/79 (5.1%) | 4/82 (4.9%) | ||||
Diarrhoea | 5/80 (6.3%) | 3/75 (4%) | 7/79 (8.9%) | 5/82 (6.1%) | ||||
Dry mouth | 5/80 (6.3%) | 6/75 (8%) | 10/79 (12.7%) | 7/82 (8.5%) | ||||
Nausea | 4/80 (5%) | 1/75 (1.3%) | 16/79 (20.3%) | 4/82 (4.9%) | ||||
Vomiting | 1/80 (1.3%) | 0/75 (0%) | 4/79 (5.1%) | 0/82 (0%) | ||||
General disorders | ||||||||
Fatigue | 2/80 (2.5%) | 6/75 (8%) | 4/79 (5.1%) | 0/82 (0%) | ||||
Infections and infestations | ||||||||
Upper respiratory tract infection | 3/80 (3.8%) | 7/75 (9.3%) | 7/79 (8.9%) | 7/82 (8.5%) | ||||
Investigations | ||||||||
Weight increase | 10/80 (12.5%) | 6/75 (8%) | 1/79 (1.3%) | 7/82 (8.5%) | ||||
Metabolism and nutrition disorders | ||||||||
Decreased appetite | 6/80 (7.5%) | 5/75 (6.7%) | 1/79 (1.3%) | 1/82 (1.2%) | ||||
Nervous system disorders | ||||||||
Akathisia | 5/80 (6.3%) | 10/75 (13.3%) | 3/79 (3.8%) | 2/82 (2.4%) | ||||
Dizziness | 2/80 (2.5%) | 2/75 (2.7%) | 5/79 (6.3%) | 5/82 (6.1%) | ||||
Headache | 6/80 (7.5%) | 4/75 (5.3%) | 7/79 (8.9%) | 7/82 (8.5%) | ||||
Sedation | 3/80 (3.8%) | 5/75 (6.7%) | 0/79 (0%) | 0/82 (0%) | ||||
Somnolence | 8/80 (10%) | 5/75 (6.7%) | 3/79 (3.8%) | 7/82 (8.5%) | ||||
Psychiatric disorders | ||||||||
Anorgasmia | 4/80 (5%) | 1/75 (1.3%) | 1/79 (1.3%) | 0/82 (0%) | ||||
Anxiety | 3/80 (3.8%) | 4/75 (5.3%) | 0/79 (0%) | 4/82 (4.9%) | ||||
Insomnia | 2/80 (2.5%) | 5/75 (6.7%) | 4/79 (5.1%) | 3/82 (3.7%) | ||||
Irritability | 3/80 (3.8%) | 1/75 (1.3%) | 4/79 (5.1%) | 3/82 (3.7%) | ||||
Reproductive system and breast disorders | ||||||||
Delayed ejaculation | 4/80 (5%) | 0/75 (0%) | 1/79 (1.3%) | 0/82 (0%) | ||||
Skin and subcutaneous tissue disorders | ||||||||
Dermatitis Contact | 4/80 (5%) | 0/75 (0%) | 1/79 (1.3%) | 1/82 (1.2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Global Clinical Development |
---|---|
Organization | Otsuka Pharmaceutical Development & Commercialization, Inc. |
Phone | 1-609-524-6788 |
clinicaltransparency@otsuka-us.com |
- 331-201-00061