Bipolar Disorder, Premenstrual Dysphoric Disorder
Conditions
Keywords
bipolar disorder, premenstrual dysphoric disorder
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.
Interventions
DRUGYaz
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
DRUGPlacebo
Appearance, packaging, and labeling of placebo will be matched to their active counterpart.
Sponsors
Hamilton Academic Health Sciences Organization
McMaster University
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: recruitment rate (monthly) | 2 years | Recruitment rate (monthly) - number of participants per month |
| 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: duration of assessment process | Screening | Duration of assessment process - mean in hours from start to finish for each visit |
| Feasibility outcome: safety of use of oral contraceptives in this population | Week 4 | Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians) |
| Feasibility outcome: tolerability | Week 4 | Tolerability - assessed as percentage dropped out after randomization due to adverse events |
| 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: 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 |
| Feasibility outcome: variance of the treatment effect | Week 12 | Variance of the treatment effect - standard deviation of above measure. |
Countries
Canada
Outcome results
None listed