Trial Outcomes & Findings for Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD) (NCT NCT01987960)
NCT ID: NCT01987960
Last Updated: 2017-03-13
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
417 participants
Primary outcome timeframe
Period 2: Baseline to Week 12 (of randomized period)
Results posted on
2017-03-13
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Period 1
STARTED
|
417
|
0
|
0
|
0
|
|
Period 1
COMPLETED
|
231
|
0
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
186
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
17
|
23
|
0
|
|
Period 2
COMPLETED
|
0
|
12
|
14
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
5
|
9
|
0
|
|
Period 3
STARTED
|
0
|
0
|
0
|
190
|
|
Period 3
COMPLETED
|
0
|
0
|
0
|
119
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
71
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Period 1
Adverse Event
|
24
|
0
|
0
|
0
|
|
Period 1
Lack of Efficacy
|
4
|
0
|
0
|
0
|
|
Period 1
Non-compliance with IMP
|
6
|
0
|
0
|
0
|
|
Period 1
Protocol Violation
|
12
|
0
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
21
|
0
|
0
|
0
|
|
Period 1
Lost to Follow-up
|
40
|
0
|
0
|
0
|
|
Period 1
administrative or other reason
|
75
|
0
|
0
|
0
|
|
Period 1
Withdrawal of consent before treatment
|
4
|
0
|
0
|
0
|
|
Period 2
Adverse Event
|
0
|
0
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Period 2
Administrative or other reason
|
0
|
5
|
7
|
0
|
|
Period 3
Adverse Event
|
0
|
0
|
0
|
7
|
|
Period 3
Non-compliance with IMP
|
0
|
0
|
0
|
1
|
|
Period 3
Protocol Violation
|
0
|
0
|
0
|
6
|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
9
|
|
Period 3
Lost to Follow-up
|
0
|
0
|
0
|
5
|
|
Period 3
Administrative or other reason
|
0
|
0
|
0
|
43
|
Baseline Characteristics
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Period 2 Placebo and PAR/SER (Randomized Period)
n=17 Participants
Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.
Placebo: Once daily, tablets, orally
|
Period 2 Brexpiprazole and PAR/SER (Randomized Period)
n=23 Participants
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
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
47.6 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
45.6 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Period 2: Baseline to Week 12 (of randomized period)Population: 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
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.
Outcome measures
| Measure |
Period 2 Absolute Mean at Baseline; Placebo and PAR/SER
n=17 Participants
Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.
Placebo: Once daily, tablets, orally
|
Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER
n=23 Participants
Period 2 absolute mean value at Baseline; 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
|
Period 2 Absolute Mean at Week 12; Placebo and PAR/SER
n=15 Participants
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); randomized period.
Placebo: Once daily, tablets, orally
Absolute values at Week 12 in Period 2 (Study Week 24)
|
Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER
n=17 Participants
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). 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
Absolute values at Week 12 in Period 2 (Study Week 24)
|
|---|---|---|---|---|
|
PTSD Symptoms Using CAPS-2 Total Score
|
82.82 Score
Standard Deviation 12.94
|
83.43 Score
Standard Deviation 13.12
|
69.67 Score
Standard Deviation 20.26
|
69.18 Score
Standard Deviation 18.17
|
SECONDARY outcome
Timeframe: Period 2: Baseline to Week 12 (of randomized period)Population: 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.
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).
Outcome measures
| Measure |
Period 2 Absolute Mean at Baseline; Placebo and PAR/SER
n=17 Participants
Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.
Placebo: Once daily, tablets, orally
|
Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER
n=23 Participants
Period 2 absolute mean value at Baseline; 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
|
Period 2 Absolute Mean at Week 12; Placebo and PAR/SER
n=15 Participants
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); randomized period.
Placebo: Once daily, tablets, orally
Absolute values at Week 12 in Period 2 (Study Week 24)
|
Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER
n=17 Participants
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). 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
Absolute values at Week 12 in Period 2 (Study Week 24)
|
|---|---|---|---|---|
|
Global Clinical Impression Severity of Illness (CGI-S) Score
|
4.24 Score
Standard Deviation 0.83
|
4.54 Score
Standard Deviation 0.73
|
3.73 Score
Standard Deviation 1.10
|
3.94 Score
Standard Deviation 0.83
|
Adverse Events
Brexpiprazole + PAR/SER (Randomized Period)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo + PAR/SER (Randomized Period)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brexpiprazole + PAR/SER (Randomized Period)
n=23 participants at risk
|
Placebo + PAR/SER (Randomized Period)
n=17 participants at risk
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
8.7%
2/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Reproductive system and breast disorders
Galactorrhoea
|
0.00%
0/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/23 • Period 2: Baseline to Week 16 (randomized period)
|
5.9%
1/17 • Period 2: Baseline to Week 16 (randomized period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place