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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Feasibility outcome: treatment compliance
Treatment compliance - assessed via number and percentage of treatment pills taken
Time frame: 12 weeks
Feasibility outcome: retention rates
Retention rates - number and percentage of people who remain in the study once randomized
Time frame: 12 weeks
Feasibility outcome: recruitment rate (monthly)
Recruitment rate (monthly) - number of participants per month
Time frame: 2 years
Feasibility outcome: recruitment capacity
Recruitment capacity - total number of participants randomized and enrolled
Time frame: 2 years
Feasibility outcome: screening rates (monthly)
Screening rates (monthly) - number screened; number enrolled as a percentage of number screened
Time frame: 2 years
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Time frame: Screening
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Time frame: Baseline
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Time frame: Week 4
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Time frame: Week 8
Feasibility outcome: duration of assessment process
Duration of assessment process - mean in hours from start to finish for each visit
Time frame: Week 12
Feasibility outcome: safety of use of oral contraceptives in this population
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Time frame: Week 4
Feasibility outcome: safety of use of oral contraceptives in this population
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Time frame: Week 8
Feasibility outcome: safety of use of oral contraceptives in this population
Safety of use of oral contraceptives in this population - adverse events reported, onset of mood episodes (assessed by clinicians)
Time frame: Week 12
Feasibility outcome: tolerability
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Time frame: Week 4
Feasibility outcome: tolerability
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Time frame: Week 8
Feasibility outcome: tolerability
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Time frame: Week 12
Feasibility outcome: response rates
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
Time frame: Week 12
Feasibility outcome: estimated treatment effect
Estimated treatment effect - mean percent change from baseline to post-treatment in percent change on the MAC-PMSS from late luteal to follicular phase
Time frame: Week 12
Feasibility outcome: variance of the treatment effect
Variance of the treatment effect - standard deviation of above measure.
Time frame: Week 12
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