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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01368068




Registration number
NCT01368068
Ethics application status
Date submitted
3/06/2011
Date registered
7/06/2011
Date last updated
31/03/2015

Titles & IDs
Public title
Investigation of Tibolone and Escitalopram in Perimenopausal Depression
Scientific title
Double-Blind Randomised Investigation of Tibolone or Escitalopram in First Onset Perimenopausal Depression
Secondary ID [1] 0 0
161/11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perimenopausal 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
Treatment: Drugs - Escitalopram
Treatment: Drugs - Natvia

Experimental: Tibolone - Subjects will take 2.5mg of oral Tibolone daily for the duration of the 12 week trial.

Active Comparator: Escitalopram - 10mg of escitalopram will be taken by participants daily for the duration of the 12 week trial period.

Placebo Comparator: Placebo - Placebo arm containing sweetener has been approved and will be used as placebo arm.


Treatment: Drugs: Tibolone
2.5mg/oral/daily

Treatment: Drugs: Escitalopram
10mg/oral/daily

Treatment: Drugs: Natvia
serving size: 0.09g per tablet

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

Outcomes
Primary outcome [1] 0 0
Montgomery and Asberg Depression Rating Scale - A 10-item clinician rated scale validated to be most strongly sensitive to change in depression associated with treatment. This scale will be used to measure change in depression associated with treatment at weeks 2, 4, 8 and 12 compared to baseline.
Timepoint [1] 0 0
Baseline, then at weeks 2, 4, 8 and 12.
Secondary outcome [1] 0 0
Short Form-36 Health Survey (SF-36) - A 36 item self report measure that assesses: physical health and bodily pain; vitality, social functioning; role limitations due to emotional problems; and mental health. This scale will be used to assess the changes to various domains of self-reported health from baseline compared to visits at baseline and week 12.
Timepoint [1] 0 0
Baseline and 12
Secondary outcome [2] 0 0
Pittsburgh Sleep Quality Index - A valid and reliable 19-item self report index measuring sleep quality, latency, duration, disturbances, and daytime dysfunction. This scale will be used to measure different domains of sleep quality at visits occurring at week baseline and week 12 compared to initial baseline measurement.
Timepoint [2] 0 0
Baseline and 12.
Secondary outcome [3] 0 0
Adverse Symptoms Checklist - A 22 item checklist of general adverse symptoms experienced. This scale will be used to measure adverse symptoms experienced by participants at weeks 2, 4, 8 and 12 compared to baseline.
Timepoint [3] 0 0
Weeks 2, 4, 8 and 12
Secondary outcome [4] 0 0
Beck Depression Inventory Scale - A subjective rating scale that compliments the MADRS and will be used at baseline and week 12 visits throughout the study.
Timepoint [4] 0 0
Baseline and week 12

Eligibility
Key inclusion criteria
- Females who are currently physically well and between 45 and 55 years of age

- Current DSM-IV diagnosis of depression disorder

- Able to give informed consent

- Perimenopausal as determined by symptom profile on the Stages of Reproductive Aging
Workshop and gonadal hormonal profile
Minimum age
45 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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 receiving treatment for depression including antidepressant medications,
electroconvulsive therapy (ECT) / Transcranial Magnetic Stimulation (TMS), formal
psychotherapy or counselling, within the past 6 months

- 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, and bipolar disorder.

- 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 and other nicotine products.

- illicit drug use and 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
3004 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT01368068
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01368068