Phase 3 N=44 Treatment

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

Sleep Disturbances

Bottom Line

View on ClinicalTrials.gov: NCT01942733 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Parameters — -24.9; -19.7; -26.4; 49.0 minutes (min)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Brexpiprazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: H. Lundbeck A/S
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Parameters	-24.9; -19.7; -26.4; 49.0	—
PRIMARY Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Number of Awakenings (PSG NAW)	0.06	—
PRIMARY Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Sleep Efficiency (PSG SE)	10.4	—
PRIMARY Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Sleep Efficiency (SE)	13.4	—
PRIMARY Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M)	69.9; -37.1; -42.9	—
PRIMARY Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Number of Awakenings (NAW)	0.0	—
PRIMARY Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography	-0.7; 3.5; -2.2; -0.6	—
PRIMARY Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography (Continued)	4.5; 43.1; -3.1; 4.5; -16.2	—
PRIMARY Change From Baseline to Week 8 in ISI Total Score	-9.2	—
PRIMARY Change From Baseline to Week 8 on ESS Total Score	-2.6	—
PRIMARY Changes From Baseline to Week 8 in Response Speed as Assessed Using a PVT Device	-0.2	—
PRIMARY Changes From Baseline to Week 8 in Number of Lapses as Assessed Using a PVT Device	2.1	—
PRIMARY Change From Baseline to Week 8 on BL-VAS-s (Evening) Score	1.4	—
PRIMARY Change From Baseline to Week 8 on BL-VAS-s (Morning) Score	-9.2	—
PRIMARY Change From Baseline to Week 8 on BL-VAS-s Scores (Noon)	-7.4	—
PRIMARY Change From Baseline to Week 8 in CPFQ Total Score	-8.4	—
PRIMARY Changes From Baseline to Week 8 in Circadian and Biological Rhythm	-60; 48; 108	—
PRIMARY Change From Baseline to Week 8 in MADRS Total Score	-16.0	—
PRIMARY Change From Baseline to Week 8 in CGI-S Score	-1.8	—
PRIMARY Percentage of MADRS Responders at Week 8	56	—
PRIMARY Percentage of MADRS Remitters at Week 8	54	—
PRIMARY Changes From Baseline to Week 8 on Sleep Quality as Assessed by Actigraphy (ACT) Parameters	-9.0; -6.1; -5.5	—
PRIMARY Changes From Baseline to Week 8 on Sleep Efficiency (SE) as Assessed by Actigraphy (ACT)	-1.3	—
PRIMARY Changes From Baseline to Week 8 on Number of Awakenings (NAW) as Assessed by Actigraphy (ACT)	-2.0	—
PRIMARY Change From Baseline to Week 8 in BRIAN Total Score	-17.4	—
PRIMARY CGI-I Score at Week 8	2.2	—

Summary

To assess effects of brexpiprazole on sleep patterns of depressed patients with sleep disturbances.

Eligibility Criteria

Inclusion Criteria - at Screening:

The patient has a Major Depressive Episode (MDE) associated to Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™). The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
The patient has an inadequate response to at least one antidepressant treatment (including the treatment the patient is taking at screening) in the current MDE, as documented by self-report as less than a pre-defined response on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ).
The patient has a pre-defined Montgomery Aasberg Depression Rating Scale (MADRS) total score, and a pre-defined Clinical Global Impression - Severity of Illness (CGI-S) score at screening, and has had the current MDE for ≥10 weeks.
The patient is currently treated for the current MDE with an adequate selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant treatment for ≥6 weeks, at the same dosage for ≥2 weeks.
The patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined Insomnia Severity Index (ISI) score.
The patient agrees to protocol-defined use of effective contraception.

Entry Criteria to Treatment Period (Baseline Visit):

The patient still fulfils DSM-IV-TR™ criteria for MDE.
The patient received the same SSRI or SNRI antidepressant treatment at adequate dose during the entire lead-in period.
The patient has a pre-defined MADRS total score.
The patient's improvement in the MADRS total score is a pre-defined percentage compared to screening.
The patient has a pre-defined Clinical Global Impression - Global Improvement (CGI-I) score.
The patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined ISI score.
The patient has sleep disturbances confirmed by pre-defined Latency to Persistent Sleep (LPS) and pre-defined Sleep Efficiency (SE).

Exclusion Criteria

The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01942733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.