The Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.
研究概览
简要总结
The goal of this series of challenge studies is to examine the impact of menstrual cycle phase on cortical GABA response to administration of agents with either direct (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While the impact of these agents on cortical GABA levels in women with premenstrual dysphoric disorder (PMDD) is of interest, this study is designed primarily for those women without a psychiatric illness.
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
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ages 18-45 and able to give voluntary written informed consent;
- •Regular menstrual periods of 24-35 days in length;
- •Body mass index 18.5 to 30 kg/m2;
- •No past or present DSM-IV psychiatric or substance dependence diagnosis by structured diagnostic interview (SCID-NP); no substance abuse history within the previous 2 years;
- •Absence of mood symptoms across the menstrual cycle during one month of prospective daily ratings with the Daily Record of Severity of Problems (DRSP); the DRSP is based on the DSM-IV research criteria for premenstrual dysphoric disorder (PMDD) and has been used in numerous studies to confirm the presence or absence of significant premenstrual mood and behavioral difficulties;
- •Must be willing and able to participate in at least three of the four challenge paradigms.
排除标准
- •Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.);
- •Family history of first degree relative with an Axis I psychiatric or substance dependence disorder (excepting alcohol and nicotine) (per subject report);
- •Current treatment with psychoactive medication;
- •Diabetes controlled by means other than diet;
- •Use of steroid contraceptives (any method involving hormones) within the previous 4 months;
- •Habitual consumption of more than 7 alcoholic drinks per week or more than 2 drinks on any particular occasion; must be willing to abstain from alcohol consumption for 48 hours prior to each 1H-MRS scan;
- •Implanted metallic devices.
研究组 & 干预措施
Zolpidem 1
Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle.
干预措施: Zolpidem (Drug)
Progesterone 2
Progesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.
干预措施: Progesterone (Drug)
Fluoxetine 3
Fluoxetine will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.
干预措施: Fluoxetine (Drug)
结局指标
主要结局
To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.
时间窗: Each medication will be administered 2 times during a 1-month menstrual cycle.
This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
次要结局
未报告次要终点