A Pilot, Randomized, Placebo-Controlled Trial Evaluating the Treatment of Premenstrual Dysphoric Disorder With Oral Contraceptives in Bipolar Disorder.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility outcome: recruitment capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Combined oral contraceptive (3mg drospirenone/ 0.02mg ethinyl estradiol)
Continuous treatment with 3mg drospirenone/ 0.02mg ethinyl estradiol for 12 weeks
干预措施: Yaz (Drug)
Placebo
Continuous treatment with placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility outcome: recruitment capacity
时间窗: 2 years
Recruitment capacity - total number of participants randomized and enrolled
Feasibility outcome: screening rates (monthly)
时间窗: 2 years
Screening rates (monthly) - number screened; number enrolled as a percentage of number screened
Feasibility outcome: treatment compliance
时间窗: 12 weeks
Treatment compliance - assessed via number and percentage of treatment pills taken
Feasibility outcome: retention rates
时间窗: 12 weeks
Retention rates - number and percentage of people who remain in the study once randomized
Feasibility outcome: duration of assessment process
时间窗: Week 12
Duration of assessment process - mean in hours from start to finish for each visit
Feasibility outcome: tolerability
时间窗: Week 12
Tolerability - assessed as percentage dropped out after randomization due to adverse events
Feasibility outcome: recruitment rate (monthly)
时间窗: 2 years
Recruitment rate (monthly) - number of participants per month
Feasibility outcome: safety of use of oral contraceptives in this population
时间窗: 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
时间窗: 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
时间窗: Week 12
Variance of the treatment effect - standard deviation of above measure.
Feasibility outcome: estimated treatment effect
时间窗: 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
次要结局
未报告次要终点
研究者
Benicio Frey
Psychiatrist/ Professor
St. Joseph's Healthcare Hamilton