Investigation of Tibolone and Escitalopram in Perimenopausal Depression
Status:
Terminated
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
Many perimenopausal women experience severe mood symptoms for the first time in their life,
with no past psychiatric history. The importance of clearly identifying and treating a
disorder that is increasingly referred to as "perimenopausal depression" is highlighted by
the wide-reaching impact this can have on the lives of women suffering from it. This is not a
minor or short term mood disturbance; it is a severe depressive illness, needing effective
and early treatment. Relationships, employment, participation in social roles and individual
well-being can all be disrupted by the combination of the mood, hormonal and physical changes
associated with the transition to menopause. The term "perimenopausal depression" denotes the
onset of depression coinciding with the onset of reproductive hormone changes.
Many women with this type of depression experience serious and long term debilitating
symptoms. Treatment commonly draws on traditional approaches for the management of major
depression including the use of antidepressants such as selective serotonin reuptake
inhibitors (SSRIs) as the first line response. However, standard treatment of perimenopausal
depression using antidepressants has only shown small improvements at best and at worst, is
associated with severe side effects. Some SSRIs have been shown to be less effective in
postmenopausal women compared to child bearing age women. Hormone treatments directly
targeting the fluctuating reproductive hormone systems (in particular estrogen) through the
administration of compounds such as tibolone, have significant potential as a better overall
treatment.
To date, there is still a lack of clear clinical evidence about the best approach for the
biological treatment of women with perimenopausal depression. The project we now propose to
conduct is a 12-week randomised controlled trial (RCT) of 2.5 mg/day tibolone compared to
10mg/day of escitalopram (an SSRI that has targeted serotonin action)compared to placebo to
discover the best treatment approach for a hitherto understudied depression that affects a
large proportion of women in their late forties and fifties.