Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Premenstrual Tension Scale (PMTS)
研究概览
简要总结
This study will determine whether characteristics of women with Premenstrual Syndrome influence response to treatment with serotonin reuptake inhibitors and whether SRIs can alleviate premenstrual symptoms.
详细描述
Moderate to severe premenstrual disturbances afflict up to 20 percent of women. Studies have shown the use of serotonin reuptake inhibitors (SRIs) during the luteal phase of the menstrual cycle to be effective in improving symptoms in women with premenstrual dysphoric disorder (PMDD). Unfortunately, SRI treatment has only been evaluated in controlled clinical trials, and evidence suggests that patients in these clinical trials are not representative of women commonly seen in clinical practice. Thus, the real-world feasibility of intermittent dosing is questionable.
Patients in this study receive sertraline (Zoloft) during the luteal phase of their menstrual cycle every month for 6 months. The dose may be modified based on structured interviews with the patients. Assessments include questionnaires and interviews which take place at study start, at midpoint, and at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DSM-IV criteria for Premenstrual syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD)
- •For a diagnosis of PMS but not PMDD, patients must have 3 to 4 symptoms, complain of functional impairment as a result of their symptoms, and identify symptoms as problematic enough to warrant treatment
- •Symptoms of PMS/PMDD in at least 9 of 12 menstrual cycles during the year prior to screening
- •Symptom-free during the follicular phase and impairment during the luteal phase
- •Regular menstrual cycles
- •Adequate methods of birth control
排除标准
- •Major depression, bipolar disorder, or psychotic disorders
- •Hepatitis or hepatic failure
- •Amenorrhea, oligomenorrhea, blood dyscrasias, or illnesses for which monoamine oxidase inhibitors must be prescribed
- •Follicular phase symptoms consistent with a diagnosis of major depression, bipolar disorder, or psychotic disorders
- •Co-existing condition that renders the patient unsuitable for the study
- •Risk of suicide
- •Antidepressants or other psychotropic medication
- •Hypersensitivity or adverse reaction to sertraline
- •Pregnancy, breast-feeding, or plans to become pregnant during the course of the study
- •Depot hormonal preparation or any other medication that would lead to lack of menses or markedly irregular menses
研究组 & 干预措施
1
Participants will receive treatment as usual
干预措施: Treatment as usual (TAU) (Other)
2
Participants will take sertraline
干预措施: Sertraline (Drug)
结局指标
主要结局
Premenstrual Tension Scale (PMTS)
时间窗: Measured at Month 8
次要结局
- Patient Global Impressions scale(Measured at Month 8)
- Quality of Life, Enjoyment, and Satisfaction Questionnaire Scale (Q-LES-Q)(Measured at Month 8)
- Inventory of Depressive Symptomatology Clinician-rated version (IDS-C)(Measured at Month 8)