Oral Contraceptives for Treating Premenstrual Dysphoric Disorder in Bipolar Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot, Randomized, Placebo-Controlled Trial Evaluating the Treatment of Premenstrual Dysphoric Disorder With Oral Contraceptives in Bipolar Disorder.

Conditions
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Premenstrual Dysphoric Disorder, Bipolar Disorder

Intervention / Treatment
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* Drug: Yaz
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol)<br>Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks | Drug: Yaz<br>* Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks<br>* Other names: 3mg drospirenone/ 0.02mg ethinyl estradiol;|
| Placebo Comparator: Placebo<br>Continuous treatment with placebo for 12 weeks | Drug: Placebo<br>* Appearance, packaging, and labeling of placebo will be matched to their active counterpart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility outcome: treatment compliance | Treatment compliance - assessed via number and percentage of treatment pills taken | 12 weeks | 
| Feasibility outcome: retention rates | Retention rates - number and percentage of people who remain in the study once randomized | 12 weeks | 
| Feasibility outcome: recruitment rate (monthly) | Recruitment rate (monthly) - number of participants per month | 2 years | 
| Feasibility outcome: recruitment capacity | Recruitment capacity - total number of participants randomized and enrolled | 2 years | 
| Feasibility outcome: screening rates (monthly) | Screening rates (monthly) - number screened; number enrolled as a percentage of number screened | 2 years | 
| Feasibility outcome: duration of assessment process | Duration of assessment process - mean in hours from start to finish for each visit | Screening | 
| Feasibility outcome: duration of assessment process | Duration of assessment process - mean in hours from start to finish for each visit | Baseline | 
| Feasibility outcome: duration of assessment process | Duration of assessment process - mean in hours from start to finish for each visit | Week 4 | 
| Feasibility outcome: duration of assessment process | Duration of assessment process - mean in hours from start to finish for each visit | Week 8 | 
| Feasibility outcome: duration of assessment process | Duration of assessment process - mean in hours from start to finish for each visit | 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) | 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) | 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) | Week 12 | 
| Feasibility outcome: tolerability | Tolerability - assessed as percentage dropped out after randomization due to adverse events | Week 4 | 
| Feasibility outcome: tolerability | Tolerability - assessed as percentage dropped out after randomization due to adverse events | Week 8 | 
| Feasibility outcome: tolerability | Tolerability - assessed as percentage dropped out after randomization due to adverse events | 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 | 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 | Week 12 | 
| Feasibility outcome: variance of the treatment effect | Variance of the treatment effect - standard deviation of above measure. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar disorder, premenstrual dysphoric disorder