The Oral Contraceptive Pill for Premenstrual Worsening of Depression.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
To determine if augmentation with the oral-contraceptive pill containing drospirenone and ethinyl estradiol is more effective than placebo in the treatment of premenstrual breakthrough of depression.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 6 months
- •Pregnancy or breastfeeding (serum HCG test administered at baseline study visit, and urine HCG at visits 3 and 5)
- •Current cigarette smoking in women who are older than 34 years
- •Presence of any of the following psychiatric and substance use disorders, based on administration of the MINI at the baseline study visit:
- •Any history of mania or hypomania suggesting bipolar disorder Any lifetime history of a psychotic disorder
- •Depression deemed by the physician investigator to be too severe to be treated in the study
- •Use of benzodiazepines or antipsychotic to target premenstrual symptoms
- •Luteal-phase dose adjustment of the antidepressant. Use of a hormone releasing IUD (intrauterine device)
- •Use of an OCP or other systemic hormonal therapies (oral, transdermal or injection preparations of androgens, estrogens, or progestins) in the past 2 months;
- •Any contraindication or previous adverse event to any OCP therapy;
- •Current use of ketoconazole, rifampin, carbamazepine, topiramate, oxcarbazepine, modafinil, phenytoin, or phenobarbital (because of interaction with hormonal therapy).
- •Current use of potassium-sparing agents, such as potassium-sparing diuretics (e.g., spironolactone), ACE inhibitors, angiotensin-II receptor antagonists, heparin, aldosterone antagonists, NSAIDS, potassium sparing diuretics or potassium-supplements (because of risk of developing arrhythmia with two potassium-elevating agents).
- •Hepatic dysfunction, renal insufficiency, pulmonary, adrenal, or metabolic diseases (including elevated serum potassium levels, if known) that may put subject at risk when treated with study medication.
研究组 & 干预措施
Drospirenone and ethinyl estradiol
干预措施: Drospirenone and ethinyl estradiol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline and 2 months
The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.
次要结局
- Percent Change in Daily Record of Severity of Problems (DRSP)(Baseline and 2 months)
研究者
Hadine Joffe, MD
Vice Chair for Research, Psychiatry Department
Brigham and Women's Hospital