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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
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Scientific title
Double-Blind Randomised Investigation of Tibolone or Escitalopram in First Onset Perimenopausal Depression
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Secondary ID [1]
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161/11
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Perimenopausal Depression
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Montgomery and Asberg Depression Rating Scale
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, then at weeks 2, 4, 8 and 12.
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Secondary outcome [1]
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Short Form-36 Health Survey (SF-36)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and 12
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Secondary outcome [2]
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Pittsburgh Sleep Quality Index
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and 12.
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Secondary outcome [3]
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Adverse Symptoms Checklist
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Assessment method [3]
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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.
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Timepoint [3]
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Weeks 2, 4, 8 and 12
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Secondary outcome [4]
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Beck Depression Inventory Scale
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Assessment method [4]
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A subjective rating scale that compliments the MADRS and will be used at baseline and week 12 visits throughout the study.
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Timepoint [4]
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Baseline and week 12
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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
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Minimum age
45
Years
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Maximum age
55
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2012
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Sample size
Target
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Accrual to date
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Final
2
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01368068
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jayashri Kulkarni, PhD,FRANZP
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Address
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Monash Alfred Psychiatry Research Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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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
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