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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] 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
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)
Timepoint [1] 0 0
Baseline and 12
Secondary outcome [2] 0 0
Pittsburgh Sleep Quality Index
Timepoint [2] 0 0
Baseline and 12.
Secondary outcome [3] 0 0
Adverse Symptoms Checklist
Timepoint [3] 0 0
Weeks 2, 4, 8 and 12
Secondary outcome [4] 0 0
Beck Depression Inventory Scale
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
Sex
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
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
2
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
Trial website
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

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