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Trial details imported from ClinicalTrials.gov

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

161/11

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Perimenopausal Depression

Condition category

Condition code

Mental Health

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Montgomery and Asberg Depression Rating Scale

Timepoint [1]

Baseline, then at weeks 2, 4, 8 and 12.

Secondary outcome [1]

Short Form-36 Health Survey (SF-36)

Timepoint [1]

Baseline and 12

Secondary outcome [2]

Pittsburgh Sleep Quality Index

Timepoint [2]

Baseline and 12.

Secondary outcome [3]

Adverse Symptoms Checklist

Timepoint [3]

Weeks 2, 4, 8 and 12

Secondary outcome [4]

Beck Depression Inventory Scale

Timepoint [4]

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

Sex

Females

Can healthy volunteers participate?

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

Stopped early

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

1/07/2012

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

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/study/NCT01368068

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Jayashri Kulkarni, PhD,FRANZP

Address

Monash Alfred Psychiatry Research Centre

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01368068

Trial Review

Registering a new trial?

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