Failure of tibolone to potentiate the pharmacological effect of fluoxetine in postmenopausal major depression.
BACKGROUND
Perimenopausal depression has been attributed to physiological progressive estrogen decline. Estrogen and derivatives have some mood-enhancing effects, although studies of using estrogen as an antidepressant have had mixed results. The gonadomimetic drug tibolone stimulates estrogen receptors in a tissue-selective fashion, increasing the gonadal activity without causing some of the usual side effects of other estrogen preparations.


METHODS
A total of 31 postmenopausal outpatients with a major depressive disorder (MDD) participated in the study. Sixteen received the antidepressant fluoxetine (20 mg/day) plus tibolone (2.5 mg/day), and 15 received the same dose of fluoxetine plus placebo, assigned in a randomized fashion.


RESULTS
After 8 weeks of treatment, the two groups had a similar level of improvement in their depressive symptoms. Both treatments were well tolerated, without significant side effects. Pretreatment and posttreatment serum hormonal levels did not predict the final response.


CONCLUSIONS
Combining tibolone and fluoxetine did not represent a more robust antidepressant response than fluoxetine alone in postmenopausal women with MDD.
Berlanga
Carlos
C
National Institute of Psychiatry, Ramón de la Fuente Clinical Research Division, Mexico, DF. cisnerb@imp.edu.mx
Mendieta
Danelia
D
Alva
Guadalupe
G
del Carmen Lara
María
M
D000368:Aged; D003866:Depressive Disorder / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D020847:Estrogen Receptor Modulators / Q000627:therapeutic use*; D004967:Estrogens / Q000097:blood; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008800:Mexico; D008875:Middle Aged; D009652:Norpregnenes / Q000627:therapeutic use*; D017698:Postmenopause; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*
D020847:Estrogen Receptor Modulators; D004967:Estrogens; D005473:Fluoxetine; D009652:Norpregnenes; D017367:Selective Serotonin Reuptake Inhibitors; C027385:tibolone