Tibolone and Placebo in Adjunct to Antidepressant Medication for Women With Menopausal Depression
Condition: Menopausal Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Longitudinal epidemiological studies have shown that many women experience significant
      physical and psychological changes as they approach menopause and for a long time following.
      Vasomotor symptoms (such as hot flushes, night sweats), sleep disturbances and changes in
      libido are common, and impact significantly on the quality of life, social and personal
      well-being. However, the major reason that many women seek help from menopause clinics or
      their doctors, is for depression and anxiety symptoms. As such, treatment commonly draws on
      traditional approaches for the management of major depression including the use of
      antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or Selective
      Norepinephrine Reuptake Inhibitors (SNRIs) as the first line response. However, standard
      treatment of menopausal 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.

      Newer therapies directly targeting the disrupted hormonal systems (in particular estrogen)
      through the administration of such compounds as tibolone, have shown significant potential to
      treat depression with the added benefit of fewer adverse side effects. With growing evidence
      supporting the use of tibolone as a viable and improved treatment for menopausal depression,
      the investigators propose to investigate the potential of tibolone, a selective Hormone
      Replacement Therapy (HRT), to ameliorate de-novo or first onset depression occurring in the
      menopausal period.
    

Detailed description: 
      All women experience menopause and a significant number suffer from ongoing, severe
      depression beginning with the major hormone fluctuations in this middle stage of life.
      Longitudinal epidemiological studies have shown that many women experience significant
      physical and psychological changes as they approach menopause and for a long time following.
      Vasomotor symptoms (such as hot flushes, night sweats), sleep disturbances and changes in
      libido are common, and impact significantly on the quality of life, social and personal
      well-being. However, the major reason that many women seek help from menopause clinics or
      their doctors is for depression and anxiety symptoms.

      Indeed, many menopausal women with no past psychiatric history experience severe mood
      symptoms during menopause for the first time in their life, and this has serious and
      debilitating long term consequences. Treatment for such depression commonly draws on
      traditional approaches for the management of major depression including the use of
      antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or selective
      norepinephrine reuptake inhibitors (SNRIs) as the first line response. However, standard
      treatment of menopausal 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 women of child bearing age.

      Newer therapies directly targeting the fluctuations in reproductive hormonal hormone systems
      (in particular estrogen, progesterone and testosterone) through the administration of such
      compounds as tibolone, have shown significant potential to treat depression with the added
      benefit of fewer adverse side effects. With growing evidence supporting the use of tibolone
      as a viable and improved treatment for menopausal depression, the investigators propose to
      investigate the potential of tibolone, a selective Hormone Replacement Therapy (HRT), to
      ameliorate de-novo or relapsing depression occurring in the menopausal period.

      Women with menopausal depression either currently using or not using an SSRI or SNRI
      medication will be involved in a 12 week randomized control trial in which they may be
      randomised to one of two groups: i) Tibolone (2.5mg oral/day) or ii) placebo.

      It is hypothesized that women receiving Tibolone in adjunct to standard antidepressant
      medication, will have the same as or a significantly greater improvement in depressive
      symptoms compared with women receiving placebo in adjunct to standard antidepressant
      medication and women not using any psychotropic/hormone treatment.
    

Intervention name(s): Tibolone
Intervention type(s): Drug
Intervention description(s): Subjects will take 2.5mg of oral Tibolone daily for the duration of the 12 week trial either alone or in adjunct to currently prescribed antidepressant medication.
Other intervention name(s): Livial
Intervention MeSH terms: Tibolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause; Depression