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Trial record 10 of 64 for:    brexpiprazole

Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01942733
Recruitment Status : Completed
First Posted : September 16, 2013
Results First Posted : March 1, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sleep Disturbances
Intervention Drug: Brexpiprazole
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brexpiprazole
Hide Arm/Group Description

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Period Title: Overall Study
Started 44
Completed 41
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Non-compliance with IMP             1
Administrative             1
Arm/Group Title Brexpiprazole
Hide Arm/Group Description

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
The all-patients-treated set (APTS) comprises all patients who took at least one dose of brexpiprazole.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
44.4  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
14
  31.8%
Male
30
  68.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   6.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
16
  36.4%
White
24
  54.5%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.3%
MADRS total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants
28.3  (3.8)
[1]
Measure Description: The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. The overall number of baseline participants was based on the full analysis set (FAS)(n=54).
CGI-S score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants
4.3  (0.8)
[1]
Measure Description: The Clinical Global Impression - Severity of Illness (CGI-S) scale assesses 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), with higher values indicating worse outcome. The overall number of baseline participants was based on the full analysis set (FAS)(n=44).
ESS total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants
9.1  (4.7)
[1]
Measure Description: The Epworth Sleepiness Scale (ESS) is a is a patient-rated scale designed to measure daytime sleepiness. The ESS consists of 8 items describing different situations/activities and the patients rate the chance of them dozing off or falling asleep when they are in these situations. Each item is rated on a 4-point scale from 0 (would never dose) to 3 (high change of dozing). The total score of the 8 items ranges from 0 to 24, with higher values indicating worse outcome. The overall number of baseline participants was based on the full analysis set (FAS)(n=44).
ISI total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants
19.4  (3.9)
[1]
Measure Description: The Insomnia Severity Index (ISI) is a patient-rated scale desgined to measure the patient’s perception of his/her insomnia. The ISI comprises 7 items.and each of the 7 items is rated on a 5-point scale from 0 (best situation) to 4 (worst situation). The total score of the 7 items ranges from 0 to 28, with higher values indicating worse outcome. The overall number of baseline participants was based on the full analysis set (FAS)(n=44).
CPFQ total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants
27.1  (5.3)
[1]
Measure Description: The Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. The overall number of baseline participants was based on the full analysis set (FAS)(n=44).
BRIAN total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants
51.7  (10.3)
[1]
Measure Description: The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) is a clinician-rated scale designed to assess biological rhythms. The BRIAN consists of 18 items divided in 4 subscales: sleep (5 items), activity (5 items), social (4 items), and eating pattern (4 items). Each item is rated on a scale from 1 (no difficulties) to 4 (serious difficulties). The total score of the 18 items ranges from 18 to 72, with higher values indicating worse outcome. The overall number of baseline participants was based on the full analysis set (FAS)(n=44).
1.Primary Outcome
Title Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Parameters
Hide Description The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 44
Mean (Standard Error)
Unit of Measure: minutes (min)
PSG LPS (n=40) -24.9  (4.8)
PSG SOL (n=40) -19.7  (3.8)
PSG WASO (n=40) -26.4  (6.1)
PSG TST (n=41) 49.0  (8.2)
2.Primary Outcome
Title Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Number of Awakenings (PSG NAW)
Hide Description The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 40
Mean (Standard Error)
Unit of Measure: number of events
0.06  (0.8)
3.Primary Outcome
Title Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Sleep Efficiency (PSG SE)
Hide Description The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: percentage (%)
10.4  (1.7)
4.Primary Outcome
Title Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Sleep Efficiency (SE)
Hide Description The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 21
Mean (Standard Error)
Unit of Measure: percentage of time
13.4  (3.2)
5.Primary Outcome
Title Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M)
Hide Description The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 44
Mean (Standard Error)
Unit of Measure: minutes (min)
CSD-M TST (n=21) 69.9  (14.6)
CSD-M SOL (n=21) -37.1  (12.3)
CSD-M WASO (n=21) -42.9  (29.0)
6.Primary Outcome
Title Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Number of Awakenings (NAW)
Hide Description The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 21
Mean (Standard Error)
Unit of Measure: number
0.0  (0.5)
7.Primary Outcome
Title Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography
Hide Description The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non–rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 44
Mean (Standard Error)
Unit of Measure: percentage of total sleep duration
Stage N1 (n=40) -0.7  (0.7)
Stage N2 (n=40) 3.5  (1.5)
Stage N3 (n=40) -2.2  (0.8)
Stage REM (n=40) -0.6  (1.1)
8.Primary Outcome
Title Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography (Continued)
Hide Description The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non–rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 44
Mean (Standard Error)
Unit of Measure: minutes
Stage N1 Duration (n=41) 4.5  (2.5)
Stage N2 Duration (n=41) 43.1  (8.3)
Stage N3 Duration (n=41) -3.1  (3.0)
Stage REM Duration (n=41) 4.5  (4.4)
Latency to REM Sleep Duration (n=38) -16.2  (14.4)
9.Primary Outcome
Title Change From Baseline to Week 8 in ISI Total Score
Hide Description The Insomnia Severity Index (ISI) is a patient-rated scale desgined to measure the patient’s perception of his/her insomnia. The ISI comprises 7 items: difficulty falling asleep, difficulty staying asleep, problems waking up early in the morning, satisfaction with current sleep pattern, interference with daily functioning, how much others notice the sleep problem impairs quality of life, and distress caused by the sleep problem. Each of the 7 items is rated on a 5-point scale from 0 (best situation) to 4 (worst situation). The total score of the 7 items ranges from 0 to 28, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: units on a scale
-9.2  (1.1)
10.Primary Outcome
Title Change From Baseline to Week 8 on ESS Total Score
Hide Description The Epworth Sleepiness Scale (ESS) is a is a patient-rated scale designed to measure daytime sleepiness. The ESS consists of 8 items describing different situations/activities and the patients rate the chance of them dozing off or falling asleep when they are in these situations. Each item is rated on a 4-point scale from 0 (would never dose) to 3 (high change of dozing). The total score of the 8 items ranges from 0 to 24, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: units on a scale
-2.6  (0.7)
11.Primary Outcome
Title Changes From Baseline to Week 8 in Response Speed as Assessed Using a PVT Device
Hide Description The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 40
Mean (Standard Error)
Unit of Measure: speed (per second)
-0.2  (0.1)
12.Primary Outcome
Title Changes From Baseline to Week 8 in Number of Lapses as Assessed Using a PVT Device
Hide Description The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 40
Mean (Standard Error)
Unit of Measure: number
2.1  (2.4)
13.Primary Outcome
Title Change From Baseline to Week 8 on BL-VAS-s (Evening) Score
Hide Description The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 33
Mean (Standard Error)
Unit of Measure: units on a scale
1.4  (4.2)
14.Primary Outcome
Title Change From Baseline to Week 8 on BL-VAS-s (Morning) Score
Hide Description The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 34
Mean (Standard Error)
Unit of Measure: units on a scale
-9.2  (4.5)
15.Primary Outcome
Title Change From Baseline to Week 8 on BL-VAS-s Scores (Noon)
Hide Description The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 23
Mean (Standard Error)
Unit of Measure: units on a scale
-7.4  (6.7)
16.Primary Outcome
Title Change From Baseline to Week 8 in CPFQ Total Score
Hide Description The Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: units on a scale
-8.4  (1.1)
17.Primary Outcome
Title Changes From Baseline to Week 8 in Circadian and Biological Rhythm
Hide Description The parameters used to assess circadian and biological rhythm were the time to peak cortisol concentration, time to dim-light melatonin onset (DLMO) and phase angle. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 9
Mean (Standard Error)
Unit of Measure: minutes
Time to peak cortisol concentration -60  (23)
Time to DLMO 48  (49)
Phase angle 108  (61)
18.Primary Outcome
Title Change From Baseline to Week 8 in MADRS Total Score
Hide Description The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: units on a scale
-16.0  (1.7)
19.Primary Outcome
Title Change From Baseline to Week 8 in CGI-S Score
Hide Description The Clinical Global Impression - Severity of Illness (CGI-S) scale assesses 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), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
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Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: units on a scale
-1.8  (0.2)
20.Primary Outcome
Title Percentage of MADRS Responders at Week 8
Hide Description The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Response was defined as a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of patients
56
21.Primary Outcome
Title Percentage of MADRS Remitters at Week 8
Hide Description The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Remission was defined as a MADRS total score ≤10 and a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of patients
54
22.Primary Outcome
Title Changes From Baseline to Week 8 on Sleep Quality as Assessed by Actigraphy (ACT) Parameters
Hide Description The key ACT parameters assessed were the total sleep time (ACT TST), wake-time after sleep onset (ACT WASO), sleep onset latency (ACT SOL), sleep efficiency (ACT SE), and the number of awakenings (ACT NAW). The results for ACT TST, ACT WASO, and ACT SOL are presented separately from ACT SE, and from ACT NAW, due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 44
Mean (Standard Error)
Unit of Measure: minutes
ACT TST (n=33) -9.0  (15.7)
ACT WASO (n=33) -6.1  (6.5)
ACT SOL (n=32) -5.5  (3.6)
23.Primary Outcome
Title Changes From Baseline to Week 8 on Sleep Efficiency (SE) as Assessed by Actigraphy (ACT)
Hide Description The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 33
Mean (Standard Error)
Unit of Measure: percentage of time
-1.3  (3.7)
24.Primary Outcome
Title Changes From Baseline to Week 8 on Number of Awakenings (NAW) as Assessed by Actigraphy (ACT)
Hide Description The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 33
Mean (Standard Error)
Unit of Measure: number of events
-2.0  (1.1)
25.Primary Outcome
Title Change From Baseline to Week 8 in BRIAN Total Score
Hide Description The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) is a clinician-rated scale designed to assess biological rhythms. The BRIAN consists of 18 items divided in 4 subscales: sleep (5 items), activity (5 items), social (4 items), and eating pattern (4 items). Each item is rated on a scale from 1 (no difficulties) to 4 (serious difficulties). The total score of the 18 items ranges from 18 to 72, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: units on a scale
-17.4  (1.9)
26.Primary Outcome
Title CGI-I Score at Week 8
Hide Description The Clinical Global Impression - Global Improvement (CGI-I) assesses the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)

Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use

Overall Number of Participants Analyzed 41
Mean (Standard Error)
Unit of Measure: units on a scale
2.2  (1.1)
Time Frame Baseline to end of treatment (Week 8)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brexpiprazole
Hide Arm/Group Description The all-patients-treated set (APTS) comprises all patients who took at least one dose of brexpiprazole.
All-Cause Mortality
Brexpiprazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brexpiprazole
Affected / at Risk (%)
Total   0/44 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brexpiprazole
Affected / at Risk (%)
Total   22/44 (50.00%) 
Gastrointestinal disorders   
Nausea * 1  6/44 (13.64%) 
General disorders   
Fatigue * 1  3/44 (6.82%) 
Infections and infestations   
Upper respiratory tract infection * 1  4/44 (9.09%) 
Investigations   
Weight increased * 1  4/44 (9.09%) 
Nervous system disorders   
Headache * 1  5/44 (11.36%) 
Sedation * 1  6/44 (13.64%) 
Somnolence * 1  4/44 (9.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study director
Organization: Email contact via H. Ludbeck A/S
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01942733     History of Changes
Other Study ID Numbers: 15352A
First Submitted: September 11, 2013
First Posted: September 16, 2013
Results First Submitted: November 16, 2015
Results First Posted: March 1, 2016
Last Update Posted: March 20, 2019