Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder
- Conditions
- Premenstrual Dysphoric DisorderBipolar Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT05098574
- Lead Sponsor
- St. Joseph's Healthcare Hamilton
- Brief Summary
This study is a pilot, randomized, placebo-controlled trial evaluating the treatment of Premenstrual Dysphoric Disorder comorbid with Bipolar Disorder using combined oral contraceptives.
Lay Summary:
This study is being done with the hope of finding a safe and effective treatment for individuals who experience both bipolar disorder and severe premenstrual symptoms. As part of this clinical trial, participants will receive either a combined oral contraceptive (i.e. oral birth control pills) as a treatment for severe premenstrual symptoms or a placebo (a pill without any active components - similar to a sugar pill). People that are enrolled in this study will either receive the treatment or the placebo for a period of 90 days. During this time, people that are participating in the study will fill out some questionnaires, and their mental and physical health will be monitored by the study physicians.
One of the goals of this study is to also understand whether it is feasible (practical) to do a larger clinical trial using this treatment in this group of people.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 16-45 years of age
- Diagnosis of BD (clinically euthymic) according to the DSM-5
- Diagnosis of PMDD according to the DSM-5
- Regular menstrual cycles
- No contraindication to use oral contraceptives
- Capable of consent for treatment
- Smoking and over the age of 35
- Current or recent (last month) use of systemic estrogen or progesterone treatment
- Severe reactions to hormone treatment
- Pregnant or breastfeeding
- Current substance use disorder
- Oophorectomy or hysterectomy
- Current unstable medical conditions
- History of current or past breast cancer, pancreatitis, migraines or blood clotting disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Continuous treatment with placebo for 12 weeks Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol) Yaz Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
- Primary Outcome Measures
Name Time Method Feasibility outcome: recruitment capacity 2 years Recruitment capacity - total number of participants randomized and enrolled
Feasibility outcome: screening rates (monthly) 2 years Screening rates (monthly) - number screened; number enrolled as a percentage of number screened
Feasibility outcome: treatment compliance 12 weeks Treatment compliance - assessed via number and percentage of treatment pills taken
Feasibility outcome: retention rates 12 weeks Retention rates - number and percentage of people who remain in the study once randomized
Feasibility outcome: duration of assessment process Week 12 Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: tolerability Week 12 Tolerability - assessed as percentage dropped out after randomization due to adverse events
Feasibility outcome: recruitment rate (monthly) 2 years Recruitment rate (monthly) - number of participants per month
Feasibility outcome: safety of use of oral contraceptives in this population Week 12 Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Feasibility outcome: response rates Week 12 Response rates - response will be defined as 50% decrease from baseline symptom change from late luteal to follicular phase; remission will be defined as number and percentage of responders who no longer need DSM-5 criteria for PMDD
Feasibility outcome: variance of the treatment effect Week 12 Variance of the treatment effect - standard deviation of above measure.
Feasibility outcome: estimated treatment effect Week 12 Estimated treatment effect - mean percent change from baseline to post-treatment in percent change on the MAC-PMSS from late luteal to follicular phase
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada