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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01470092




Registration number
NCT01470092
Ethics application status
Date submitted
9/11/2011
Date registered
11/11/2011
Date last updated
9/01/2020

Titles & IDs
Public title
Tibolone and Placebo in Adjunct to Antidepressant Medication for Women With Menopausal Depression
Scientific title
Double-Blind Randomised Investigation of Tibolone Alone or in Adjunct to Standard Antidepressant Treatment for Depression in Menopausal Women
Secondary ID [1] 0 0
485/11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopausal Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tibolone

Active Comparator: Tibolone - 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 anti-depressant medication.

No Intervention: Placebo - Subjects will take oral placebo tablets packaged daily for the duration of the 12 week trial either alone or in adjunct to currently prescribed antidepressant medication.


Treatment: Drugs: Tibolone
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery and Asberg Depression Rating Scale
Timepoint [1] 0 0
Baseline, then at weeks 2,4, 8 and 12
Secondary outcome [1] 0 0
The Beck Depression Inventory Second Edition
Timepoint [1] 0 0
Baseline and week 12

Eligibility
Key inclusion criteria
- Females who are currently physically well and between 45 and 65 years of age

- Current DSM-IV diagnosis of depression disorder

- Able to give informed consent

- Menopausal as determined by standardized classification guidelines for female
reproductive aging were proposed at the Stages of Reproductive (STRAW) -Aging Workshop
and symptom profile on the STRAW

- First-onset or relapse depression during menopause

- Currently taking either an SSRI or SNRI, or no psychotropic medication at all

- Evidence of a normal mammogram in the preceding 12 months.
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with known abnormalities in the hypothalamic-pituitary gonadal axis, thyroid
dysfunction, central nervous system tumours, active or past history of a venous
thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal Pap
smear results in the previous 2 years.

- Patients with any significant unstable medical illness such as epilepsy and diabetes
or known active cardiac, renal or liver disease; or the presence of illness causing
immobilisation.

- Patients experiencing severe melancholia, neurovegetative symptoms or current
suicidality necessitating acute hospitalisation or intensive psychiatric treatment.

- Patients with psychotic symptoms or past history of severe mental illness including
schizophrenia.

- Use of any form of estrogen, progestin or androgen as hormonal therapy, or
antiandrogen including Tibolone or use of phytoestrogen supplements as powder or
tablet

- Pregnancy / Lactation

- Smoking cigarettes or other nicotine products

- Illicit drug use

- More than 3 standard drinks per day

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01470092
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jayashri Kulkarni, PhD,FRANZP
Address 0 0
Monash Alfred Psychiatry Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries