Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000475549p
Ethics application status
Submitted, not yet approved
Date submitted
20/03/2024
Date registered
17/04/2024
Date last updated
17/04/2024
Date data sharing statement initially provided
17/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised double-blinded interventional trial of Estradiol and Zoloft to treat Menopausal Depression
Scientific title
A randomised double-blinded interventional trial of the efficacy of Estradiol and Zoloft in treating Menopausal Depression
Secondary ID [1] 311780 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopausal depression 333288 0
Depression 333289 0
Menopause 333290 0
Condition category
Condition code
Mental Health 329978 329978 0 0
Depression
Reproductive Health and Childbirth 330143 330143 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
50mcg estradiol transdermal patch applied twice a week and 100mg prometrium oral tablet taken daily (both for 12 weeks in total)
Adherence will be assessed at each visit with participant reporting number of pills left
Intervention code [1] 328232 0
Treatment: Drugs
Comparator / control treatment
100mg sertraline (Zoloft) tablet taken daily for 12 weeks
Control group
Active

Outcomes
Primary outcome [1] 337744 0
Menopausal depression
Timepoint [1] 337744 0
Baseline and Week 12 post-commencement of intervention
Primary outcome [2] 337745 0
Menopausal depression
Timepoint [2] 337745 0
Baseline and Week 12 post-commencement of intervention
Secondary outcome [1] 433100 0
Menopausal depression
Timepoint [1] 433100 0
Baseline vs Week 12 post-commencement of intervention
Secondary outcome [2] 434153 0
Menopausal depression
Timepoint [2] 434153 0
Baseline vs Week 12 post-commencement of intervention

Eligibility
Key inclusion criteria
i. Females who are currently physically well
ii. 45 – 60 years of age
iii. Current DSM-5 diagnosis of depression disorder
iv. MENO-D score > 20
v. Able to give informed consent
vi. Menopausal as determined by standardised classification guidelines for female reproductive aging (Stages of Reproductive – STRAW)
vii. First-onset or relapse of depression during menopause
viii. Evidence of a normal mammogram in the preceding 24 months
ix. Documented normal Pap smear and pelvic examination in the preceding two years
x. English language proficiency (to provide informed consent and complete cognitive test battery)
Minimum age
45 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
i. 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.
ii. 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.
iii. Patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment.
iv. Patients whose depressive illness is directly related to illicit substance use
v. Patients with psychotic symptoms or past history of severe mental illness including schizophrenia, and bipolar disorder.
vi. Pregnancy / Lactation
vii. Smoking > 10 cigarettes per day, >3 standard drinks of alcohol per day, illicit drug use.
viii. Planned changes to psychotropic medication or psychotherapy regimen.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/07/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2027
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26290 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 42261 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 316114 0
University
Name [1] 316114 0
Monash University
Country [1] 316114 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318291 0
None
Name [1] 318291 0
Address [1] 318291 0
Country [1] 318291 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314946 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314946 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 314946 0
Australia
Date submitted for ethics approval [1] 314946 0
18/03/2024
Approval date [1] 314946 0
Ethics approval number [1] 314946 0

Summary
Brief summary
Depressive symptoms are prevalent among middle-aged women, especially during the menopausal transition. However, the impact of menopause on depression is often overlooked, leading to inadequate treatment and poor outcomes. While current guidelines recommend traditional antidepressants as first-line management, the evidence for hormonal therapy is limited. To address this gap, we propose a new clinical trial comparing the efficacy of Menopause Hormone Therapy and antidepressants in treating menopausal depression. Given that menopausal depression most likely stems from hormonal fluctuations, it is hypothesised that hormonal treatments are more appropriate than antidepressants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133206 0
Prof Jayashri Kulkarni
Address 133206 0
Monash Alfred Psychiatry research centre, Level 4, 607 St Kilda Road, Melbourne 3004 VIC
Country 133206 0
Australia
Phone 133206 0
+61 390766924
Fax 133206 0
Email 133206 0
jayashri.kulkarni@monash.edu
Contact person for public queries
Name 133207 0
Dr Eveline Mu
Address 133207 0
Monash Alfred Psychiatry research centre, Level 4, 607 St Kilda Road, Melbourne 3004 VIC
Country 133207 0
Australia
Phone 133207 0
+61 390766564
Fax 133207 0
Email 133207 0
eveline.mu@monash.edu
Contact person for scientific queries
Name 133208 0
Dr Eveline Mu
Address 133208 0
Monash Alfred Psychiatry research centre, Level 4, 607 St Kilda Road, Melbourne 3004 VIC
Country 133208 0
Australia
Phone 133208 0
+61 390766564
Fax 133208 0
Email 133208 0
eveline.mu@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual data (de-identified) for the primary and secondary outcomes
When will data be available (start and end dates)?
Immediately following publication and available for 5 years after publication
Available to whom?
Upon email request to Principal Investigator
Available for what types of analyses?
Any
How or where can data be obtained?
Via email (jayashri.kulkarni@monash.edu) request to the Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.