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Effects of Adjunctive Brexpiprazole on Sleep Disturbances in Patients With Major Depressive Disorder: An Open-Label, Flexible-Dose, Exploratory Study.

Publication ,  Journal Article
Krystal, AD; Mittoux, A; Meisels, P; Baker, RA
Published in: Prim Care Companion CNS Disord
September 8, 2016

BACKGROUND: Brexpiprazole is a serotonin-dopamine activity modulator. We evaluated the effects of adjunctive treatment with brexpiprazole on sleep disturbances in patients with DSM-IV-TR major depressive disorder (MDD) and inadequate response to antidepressant treatment. METHODS: This study was conducted between September 27, 2013, and August 19, 2014. Patients with inadequate response to antidepressant treatment and sleep disturbances continued treatment with their current antidepressant for 2 weeks. Patients still having inadequate response and sleep efficiency less than 85% measured by baseline polysomnography (PSG) received 8-week open-label treatment with their current antidepressant treatment and adjunctive brexpiprazole (target dose: 3 mg/d). Assessments included PSG recordings and scales of insomnia severity, depressive symptoms, and daytime alertness and functioning. Changes from baseline to week 8 were analyzed. RESULTS: Forty-four patients were treated. Improvements (P < .05) measured by PSG and Consensus Sleep Diary for Morning, respectively, were observed in sleep efficiency (10.4 and 15.4 percentage points), total sleep time (49.0 and 84.5 min), sleep onset latency (-19.7 and -42.6 min), wake-time after sleep onset (-26.4 and -48.0 min), and latency to persistent sleep (-24.9 min, PSG only). Insomnia Severity Index (ISI) total score was improved (-9.2), as was daytime sleepiness (-2.1) as measured by the Epworth Sleepiness Scale (ESS) total score and morning sleepiness (-9.2) as measured by the Bond-Lader Visual Analog Scale (all P < .05). Reaction time was slightly decreased (-0.2 sec-1) by treatment (P < .05). Depressive symptoms improved (Montgomery-Asberg Depression Rating Scale [MADRS]: -16.0 and Clinical Global Impressions-Severity [CGI-S]: -1.8), as did functioning (-8.4) assessed by the Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (all P < .05). Improvements in depressive symptoms were dependent on sleep (as assessed by ISI) (P < .0001) and improvements in daytime alertness (as assessed by ESS) were dependent on improvements in ISI (P = .009). No new safety concerns were observed compared to previous brexpiprazole studies. CONCLUSIONS: In patients with inadequate response to antidepressant treatment and sleep disturbances treated with adjunctive brexpiprazole, physiologic measures of sleep and daytime alertness were improved. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01942733.

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Published In

Prim Care Companion CNS Disord

DOI

EISSN

2155-7780

Publication Date

September 8, 2016

Volume

18

Issue

5

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Thiophenes
  • Sleep Wake Disorders
  • Serotonin Agents
  • Quinolones
  • Middle Aged
  • Male
  • Humans
  • Female
  • Drug Therapy, Combination
 

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Krystal, A. D., Mittoux, A., Meisels, P., & Baker, R. A. (2016). Effects of Adjunctive Brexpiprazole on Sleep Disturbances in Patients With Major Depressive Disorder: An Open-Label, Flexible-Dose, Exploratory Study. Prim Care Companion CNS Disord, 18(5). https://doi.org/10.4088/PCC.15m01914
Krystal, Andrew D., Aurélia Mittoux, Peter Meisels, and Ross A. Baker. “Effects of Adjunctive Brexpiprazole on Sleep Disturbances in Patients With Major Depressive Disorder: An Open-Label, Flexible-Dose, Exploratory Study.Prim Care Companion CNS Disord 18, no. 5 (September 8, 2016). https://doi.org/10.4088/PCC.15m01914.
Krystal, Andrew D., et al. “Effects of Adjunctive Brexpiprazole on Sleep Disturbances in Patients With Major Depressive Disorder: An Open-Label, Flexible-Dose, Exploratory Study.Prim Care Companion CNS Disord, vol. 18, no. 5, Sept. 2016. Pubmed, doi:10.4088/PCC.15m01914.

Published In

Prim Care Companion CNS Disord

DOI

EISSN

2155-7780

Publication Date

September 8, 2016

Volume

18

Issue

5

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Thiophenes
  • Sleep Wake Disorders
  • Serotonin Agents
  • Quinolones
  • Middle Aged
  • Male
  • Humans
  • Female
  • Drug Therapy, Combination