Zoely vs. Zoloft in Premenstrual Dysphoric Disorder

Phase 2

Recruiting

Conditions: premenstrual dysphoric disorder
Mental Health - Depression

Registration Number: ACTRN12623000496617

Lead Sponsor: Monash University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 160

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

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

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Daily Record of Severity of Problems (DRSP) in the luteal phase[ 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) <br>]

Secondary Outcome Measures

Name	Time	Method
Depression, anxiety and stress scale (DASS)[ Change in DASS scores over time from Baseline to week 12];Montgomery-Asberg Depression Rating Scale (MADRS) <br>[ Change in MADRS scores over time from Baseline to week 12]