Treatment of depression and menopause-related symptoms with the serotonin-norepinephrine reuptake inhibitor duloxetine.
BACKGROUND
Postmenopausal women with depression frequently have co-occurring symptoms of hot flashes (vasomotor symptoms), sleep disturbance, anxiety, and pain. Treatment strategies that target all of these symptoms together have not been investigated to date.


METHODS
Study participants were postmenopausal women, 40 to 60 years old, with major depressive disorder (DSM-IV criteria) and vasomotor symptoms. The study design included a 2-week, single-blind placebo run-in phase followed by an 8-week open-label flexible-dosing (60-120 mg per day) study of duloxetine for women who did not respond to placebo. The primary outcome measure was change in Montgomery-Asberg Depression Rating Scale (MADRS) score during 8 weeks of duloxetine therapy. Secondary outcome measures included changes in vasomotor symptoms, sleep quality, anxiety, and pain. Analyses were conducted using non-parametric methods. Patients were enrolled in the study from May 31, 2005, through May 22, 2006.


RESULTS
Of 30 women eligible to participate in this study, 20 initiated treatment with open-label duloxetine. Fourteen (70.0%) of these women completed the study. There was a statistically significant decrease in MADRS scores after 8 weeks of treatment (p < .001), with scores declining from 19.0 (interquartile range [IQR] = 15.0-21.0) to 5.5 (IQR = 3.0-9.0). There was also a statistically significant improvement in vasomotor symptoms (p = .003), anxiety (p = .002), sleep quality (p < .001), and pain (p < .05).


CONCLUSIONS
Postmenopausal women with depression and vasomotor symptoms had significant improvement in depression, vasomotor symptoms, sleep, anxiety, and pain after 8 weeks of open-label duloxetine therapy. Given the common co-occurrence of these symptoms in postmenopausal women, duloxetine may offer important therapeutic benefits for postmenopausal women who have depression and menopause-related symptoms.
Joffe
Hadine
H
Perinatal and Reproductive Psychiatry Program, Department of Psychiatry, Massachusetts General Hospital, Boston, Mass. 02114, USA. hjoffe@partners.org
Soares
Claudio N
CN
Petrillo
Laura F
LF
Viguera
Adele C
AC
Somley
Brittny L
BL
Koch
Jennifer K
JK
Cohen
Lee S
LS
D000328:Adult; D001007:Anxiety / Q000188:drug therapy; D003865:Major Depressive Disorder / Q000188:drug therapy*; D000068736:Duloxetine Hydrochloride; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D017698:Postmenopause / Q000523:psychology; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016037:Single-Blind Method; D012893:Sleep Wake Disorders / Q000188:drug therapy; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes