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Trial registered on ANZCTR


Registration number
ACTRN12623000496617
Ethics application status
Approved
Date submitted
1/05/2023
Date registered
15/05/2023
Date last updated
23/05/2024
Date data sharing statement initially provided
15/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Zoely vs. Zoloft in Premenstrual Dysphoric Disorder
Scientific title
A randomised double-blinded interventional pilot of Zoely and Zoloft to treat Premenstrual Dysphoric Disorder
Secondary ID [1] 309535 0
None
Universal Trial Number (UTN)
U1111-1291-8407
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
premenstrual dysphoric disorder 329821 0
Condition category
Condition code
Mental Health 326718 326718 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 : Sertraline 100mg oral tablet daily for 3 months or
Arm 2: Nomegestrol acetate (2.5mg) and 17-beta estradiol (1.5mg) (Zoely) oral tablet daily for 3 months.
Intervention code [1] 325964 0
Treatment: Drugs
Comparator / control treatment
Comparator is Arm 1 Sertraline 100mg
Control group
Active

Outcomes
Primary outcome [1] 334589 0
Change in the Daily Record of Severity of Problems (DRSP) in the luteal phase
Timepoint [1] 334589 0
7-days before menses, to 7-days after menses, and to be completed across two menstrual cycles in months 1 and 2 and months 3-5 (treatment)
Secondary outcome [1] 421313 0
Depression, anxiety and stress scale (DASS)
Timepoint [1] 421313 0
Change in DASS scores over time from Baseline to week 12
Secondary outcome [2] 421317 0
Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [2] 421317 0
Change in MADRS scores over time from Baseline to week 12

Eligibility
Key inclusion criteria
Women of reproductive age (18-50 years) with regular menstrual cycles who:
1. Meet the DSM-5 diagnostic criteria for PMDD
2. Report at least one-year history of regularly experiencing PMDD symptoms, with sudden onset and sudden offset of depressive symptoms. This may or may not directly coincide with the luteal phase
3. Must use appropriate barrier contraception precaution
4. Demonstrated capacity to give informed consent
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are:
1. Unable to provide informed consent
2. Women taking the OCP, using a hormonal intrauterine device (IUD) or contraceptive implant (Implanon)
3. Known history of estrogen dependent cancers (individual)
4. Contraindications to estradiol
5. History of blood clots (e.g., deep vein thrombosis, pulmonary embolism)
6. Clinical evidence of acute delirium or severe head injury
7. Presenting with ongoing, acute clinically-significant risk of suicide, as determined by PI (psychiatrist) on the basis of clinical assessment
8. Lifetime diagnosis of schizophrenia, schizoaffective disorder, substance-induced psychotic disorder or bipolar I disorder
9. Substance dependence requiring intervention or rehabilitation in the last 3 months
10. Currently pregnant or breastfeeding

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)
The Alfred Clinical Trials Pharmacy will perform trial randomisation, allocate, and dispense treatment. Study participants and research staff will remain blind to the intervention. A designated senior staff member who is not involved in the conduct of the study will facilitate unblinding due to any adverse event. Participants will receive notification of their results after the study is completed. Each participant will have a sealed opaque envelopes with their arm allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants who pass screening will be assigned by a permuted block 1:1 randomisation to be allocated to one of the two study arms
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 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be collated, cleaned and validated using programmed edit checks, and stored in a secure database that will be locked to the Biostatistician and the Principal Investigators prior to reaching the recruitment target and analysis of the primary endpoint. This primary analysis will take place after all participants, apart from those who may have withdrawn, have had their final assessments. All randomised participants will be included in the statistical analysis (i.e., intention-to-treat) for primary and secondary outcomes
The primary analyses will compare, using the paired samples t-test:
1. The average of daily total DRSP scores for both the luteal and follicular phases between the pre-treatment (months 1 and 2) and treatment (months 3, 4 and 5) phases
2. The average of the total MADRS scores for both the luteal and follicular phases between the pre-treatment (months 1 and 2) and treatment (months 3, 4 and 5) phases
3. The average of the total DASS-21 scores for both the luteal and follicular phases between the pre-treatment (months 1 and 2) and treatment (months 3, 4 and 5) phases.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/05/2024
Actual
7/05/2024
Date of last participant enrolment
Anticipated
3/02/2026
Actual
Date of last data collection
Anticipated
25/06/2026
Actual
Sample size
Target
160
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24615 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 40222 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 313728 0
University
Name [1] 313728 0
Monash University
Country [1] 313728 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 315564 0
None
Name [1] 315564 0
Address [1] 315564 0
Country [1] 315564 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312898 0
The Alfred Ethics Committee
Ethics committee address [1] 312898 0
Ethics committee country [1] 312898 0
Australia
Date submitted for ethics approval [1] 312898 0
03/05/2023
Approval date [1] 312898 0
16/08/2023
Ethics approval number [1] 312898 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126266 0
Prof Jayashri Kulkarni
Address 126266 0
Monash Alfred Psychiatry research centre
Level 4, 607 St Kilda Rd
Melbourne VIC 3004
Country 126266 0
Australia
Phone 126266 0
+61 3 9076 6564
Fax 126266 0
Email 126266 0
jayashri.kulkarni@monash.edu
Contact person for public queries
Name 126267 0
Emorfia Gavrilidis
Address 126267 0
Monash Alfred Psychiatry research centre
Level 4, 607 St Kilda Road
Melbourne VIC 3004
Country 126267 0
Australia
Phone 126267 0
+61 3 9076 6564
Fax 126267 0
Email 126267 0
emmy.gavrilidis@monash.edu
Contact person for scientific queries
Name 126268 0
Eveline Mu
Address 126268 0
Monash Alfred Psychiatry research centre
Level 4, 607 St Kilda Road
Melbourne VIC 3004
Country 126268 0
Australia
Phone 126268 0
+61 3 9076 6589
Fax 126268 0
Email 126268 0
eveline.mu@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.